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Cumulative List of All Orphan Designated Products

Total Number of Active Designations 1749 Effective: 10/3/2007

Generic Name Approved Orphan Indication:

Trade Name:
Valortim Orphan Designation:
Treatment of anthrax infection

Designation
2/16/2006 Sponsor and Address
Marketing Exclusivity PharmAthene, Inc.
One Park Place
Suite 450
Annapolis MD 21401
***************************************************************************************
Generic Name Approved Orphan Indication:
(+/-)-7-[3-(4-acetyl-3-methoxy-2-
propylphenoxy)propoxy]-3,4-dihydro-8-propyl-2H-1-

Trade Name:
Orphan Designation:
Prevention of serious adverse events associated with vascular leak
syndrome caused by Interleukin-2 therapy
Designation
3/31/2003 Sponsor and Address
Marketing Exclusivity Intarcia Therapeutics, Inc.
2000 Powell Street
Suite 1640
Emeryville CA 94608
***************************************************************************************
Generic Name Approved Orphan Indication:
(1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-
methoxy-alpha-(1-naphthyl)-beta-phenyl-3-
quinolineethanol

Trade Name:
Orphan Designation:
Treatment of pulmonary tuberculosis (active disease)

Designation
1/10/2005 Sponsor and Address
Marketing Exclusivity Tibotec, Inc.
1020 Stony Hill Road
Yardley PA 19067

***************************************************************************************
Generic Name Approved Orphan Indication:
(1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-
imino-D-ribitol-hydrochloride

Trade Name:
Orphan Designation:
Treatment of chronic lymphocytic leukemia and related leukemias to
include prolymphocytic leukemia, adult T-cell leukemia, and hairy
Designation cell leukemia
8/10/2004 Sponsor and Address
Marketing Exclusivity BioCryst Pharmaceuticals, Inc.
2190 Parkway Lake Drive
Birmingham AL 35244

***************************************************************************************
Generic Name Approved Orphan Indication:
(1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-
imino-D-ribitol-hydrochloride

Trade Name:
Orphan Designation:
Treatment of acute lymphoblastic leukemia

Designation
8/13/2004 Sponsor and Address
Marketing Exclusivity BioCryst Pharmaceuticals, Inc.
2190 Parkway Lake Drive
Birmingham AL 35244

***************************************************************************************
Generic Name Approved Orphan Indication:
(1S)-1-(9-deazahypoxanthin-9-yl)-1,4-dideoxy-1,4-
imino-D-ribitol-hydrochloride

Trade Name:
Orphan Designation:
Treatment of T-cell non-Hodgkin's lymphoma

Designation
1/29/2004 Sponsor and Address
Marketing Exclusivity BioCryst Pharmaceuticals, Inc.
2190 Parkway Lake Drive
Birmingham AL 35244

***************************************************************************************
Generic Name Approved Orphan Indication:
(2Z)-2-cyano-3-3hydroxy-N-[4-(trifluoromethly)phenyl]-
2-hepten-6-ynamide

Trade Name:
FK778 Orphan Designation:
Prevention of acute rejection following kidney, heart, and liver
tranplantation
Designation
1/10/2005 Sponsor and Address
Marketing Exclusivity Fujisawa Healthcare, Inc.
Three Parkway North
Deerfield IL 60015-2548

***************************************************************************************
Generic Name Approved Orphan Indication:
(3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic
acid
Trade Name:
Orphan Designation:
For use in the treatment of cystic fibrosis resulting fron a nonsense
(premature stopcodon) mutation in the cystic bibrosis transmembrane
Designation conductance regulatory gene.
9/1/2004 Sponsor and Address
Marketing Exclusivity PTC Therapeutics
100 Corporate Court
South Plainfield NJ 07080

***************************************************************************************
Generic Name Approved Orphan Indication:
(3-[5-(2-fluoro-phenyl)-[1,2,4]oxadiazole-3-yl]-benzoic
acid)

Trade Name:
Orphan Designation:
Treatment of Muscular Dystrophy resulting from premature stop
mutations in the dystrohin gene.
Designation
1/10/2005 Sponsor and Address
Marketing Exclusivity PTC Therapeutics, Inc.
100 Corporate Court
South Plainfield NJ 07080

***************************************************************************************
Generic Name Approved Orphan Indication:
(3S)-3-(4-trifluoromethoxybenzyloxy)-6-nitro-2H-3,4-
dihydroimidazo[2,1-b]oxazine

Trade Name:
Orphan Designation:
Treatment of tuberculosis.

Designation
7/5/2007 Sponsor and Address
Marketing Exclusivity Global Alliance for TB Drug Development
80 Broad Street
New York NY 10004

***************************************************************************************
Generic Name Approved Orphan Indication:
(3S)-3-[(2S)-2-({N-[2-tert-
butyl)phenyl]carbamoyl}carbonylamino)
propanoylamino]-4-oxo-5-(2,3,5,6-

Trade Name:
Orphan Designation:
Treatment of patients undergoing solid organ transplantation.

Designation
8/19/2003 Sponsor and Address
Marketing Exclusivity Pfizer Global Research and Development
50 Pequot Avenue
New London CT 06320

***************************************************************************************
Generic Name Approved Orphan Indication:
(4S)-4-ethyl-4-hydroxy-3,14-dioxo-3,4,12,14-
tetrahydro-1-H-pyrano[3?,4?:6,7]-indolizino-[1,2-b]-
quinoline-11-carbaldehyde O-(tert-butyl)-(E)-oxime

Trade Name:
Gimatecan Orphan Designation:
Treatment malignant glioma

Designation
11/29/2002 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
One Health Plaza
Building 105
East Hanover NJ 07936-1080
***************************************************************************************
Generic Name Approved Orphan Indication:
(6R,S)5,10-methylene-tetrahydrofolic acid

Trade Name:
CoFactor Orphan Designation:
For use in combination with 5-fluorouracil for the treatment of
patients with pancreatic cancer
Designation
8/13/2004 Sponsor and Address
Marketing Exclusivity Adventrx Pharmaceuticals, Inc.
6725 Mesa Ridge Road
Suite 100
San Diego CA 92121
***************************************************************************************
Generic Name Approved Orphan Indication:
(9-[N-(3-morpholinopropyl)-sulfonyl]-5,6-dihydro-5-
oxo-11-H-indeno [1,2-c] isoquinoline

Trade Name:
Orphan Designation:
Prevention of post-operative complications of aortic anuerysm
surgical repair
Designation
12/8/2004 Sponsor and Address
Marketing Exclusivity Inotek Pharmaceuticals Corporation
100 Cummings Center
Beverly MA 01915

***************************************************************************************
Generic Name Approved Orphan Indication:
(R)-2-methyl-6-nitro-2-{4-[4-(4-
trifluoromethoxyphenoxy)piperidin-1-
yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole

Trade Name:
Orphan Designation:
Treatment of pulmonary tuberculosis.

Designation
7/12/2007 Sponsor and Address
Marketing Exclusivity Otsuka Pharmaceutical Company, Ltd
2440 Research Blvd
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
(R)-N-[2-(6-chloro-5-methoxy-1H-indol-3-
yl)propyl]acetamide

Trade Name:
Orphan Designation:
Treatment of circadian rhythm sleep disorders in blind people with no
light perception
Designation
10/3/2001 Sponsor and Address
Marketing Exclusivity Phase 2 Discovery, Inc.
3130 Highland Avenue, Third Floor
Cincinnati OH 45219-2374

***************************************************************************************
Generic Name Approved Orphan Indication:
(R)-N-[2-(6-Chloro-methoxy-1H-indol-
3yl)propyl]acetamide
Trade Name:
Orphan Designation:
Treatment of neuroleptic-induced tardive dyskinesia in schizophrenia
patients
Designation
7/3/2003 Sponsor and Address
Marketing Exclusivity Phase 2 Discovery, Inc.
3130 Highland Ave.
Third Floor
Cincinnati OH 45219
***************************************************************************************
Generic Name Approved Orphan Indication:
(UDU-stereoisomer of c-UJUun UNU-terminal
UkUnhibitor)

Trade Name:
Orphan Designation:
Treatment of acute sensorineural hearing loss

Designation
3/28/2006 Sponsor and Address
Marketing Exclusivity Auris Medical, Inc.
211 East Ontario Street
Chicago IL 60611

***************************************************************************************
Generic Name Approved Orphan Indication:
[5,10,15,20-tetrakis(1,3-diethylimidazolium-2-
yl)porphyrinato] manganese(III)pentachloride

Trade Name:
Orphan Designation:
Treatment of Amyotrophic Lateral Sclerosis

Designation
11/4/2003 Sponsor and Address
Marketing Exclusivity Aeolus Pharmaceuticals, Inc.
PO Box 14287; 79 T.W. Alexander Dr.
4401 Research
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
1,1'-[1,4-phenylenebis(methylene)-bis-1,4,8,11-
tetraazacyclotetradecan

Trade Name:
Orphan Designation:
For use to improve the yield of progentor cells in the apheresis
product for subsequest stem cell transplantation following
Designation myelosuppressive or myeloablative chemotherapy
7/10/2003 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
500 Kendall Street
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
1,2-bis(methylsulfonyl)-1-(2-chloroethyl)-2-
[(methylamino)carbonyl]hydrazine

Trade Name:
Cloretazine Orphan Designation:
Treatment of acute myelogenous leukemia

Designation
10/21/2004 Sponsor and Address
Marketing Exclusivity Vion Pharmaceuticals, Inc.
Four Science Park
New Haven CT 06511

***************************************************************************************
Generic Name Approved Orphan Indication:
1,5-(Butylimino)-1,5 dideoxy,D-glucitol

Trade Name:
Orphan Designation:
Treatment of Fabry's disease.

Designation
5/12/1998 Sponsor and Address
Marketing Exclusivity Oxford GlycoSciences
10, The Quadrant
Abington Science Park
United Kingdom
UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
111Indium pentetreotide

Trade Name:
SomatoTher Orphan Designation:
Treatment of somatostatin receptor positive neuroendocrine tumors.

Designation
6/10/1999 Sponsor and Address
Marketing Exclusivity Louisiana State University Medical Center Foundation
1600 Canal St.
10th Floor
New Orleans LA 70112
***************************************************************************************
Generic Name Approved Orphan Indication:
166Ho-DOTMP

Trade Name:
Orphan Designation:
Treatment of multiple myeloma.

Designation
2/10/1999 Sponsor and Address
Marketing Exclusivity NeoRx Corporation
410 W. Harrison Street
Seattle WA 98119-4007

***************************************************************************************
Generic Name Approved Orphan Indication:
17 a-Hydroxyprogesterone caproate

Trade Name:
Gestiva Orphan Designation:
Prevention of preterm birth in singleton pregnancies

Designation
1/25/2007 Sponsor and Address
Marketing Exclusivity Adeza Biomedical
1240 Elko Drive
Sunnyvale CA 94089

***************************************************************************************
Generic Name Approved Orphan Indication:
17-alltlamino-17-demethoxygeldanamycin (17-AGG)

Trade Name:
Orphan Designation:
Treatment of multiple myeloma.

Designation
9/9/2004 Sponsor and Address
Marketing Exclusivity Kosan Biosciences, Inc
3832 Bay Center Place
Hayward CA 94545

***************************************************************************************
Generic Name Approved Orphan Indication:
17-allylamino-17-demethoxygeldanamycin (17-AGG)

Trade Name:
Orphan Designation:
For the treatment of chronic myelogenous leukemia

Designation
9/3/2004 Sponsor and Address
Marketing Exclusivity Kosan Biosciences, Inc.
3832 Bay Center Place
Hayward CA 94545

***************************************************************************************
Generic Name Approved Orphan Indication:
1-Deoxygalactonojirimycin

Trade Name:
Orphan Designation:
Treatment of Fabry Disease

Designation
2/25/2004 Sponsor and Address
Marketing Exclusivity Amicus Therapeutics, Inc.
6 Cedar Brook Drive
Cranbury NJ 08512

***************************************************************************************
Generic Name Approved Orphan Indication:
1-dexynojirimycin hydrochloride

Trade Name:
Orphan Designation:
Treatment of Pompe disease

Designation
6/18/2007 Sponsor and Address
Marketing Exclusivity Amicus Therapeutics, Inc
6 Cedar Brook Drive
Cranbury NJ 08512

***************************************************************************************
Generic Name Approved Orphan Indication:
2-(3,5-dichloro-phenyl)-benzoxazole-6-carboxylic
acid
Trade Name:
Orphan Designation:
Treatment of familial amyloid polyneuropathy

Designation
5/23/2006 Sponsor and Address
Marketing Exclusivity FoldRx Pharmaceuticals, Inc.
300 Technology Square
Cambridge MA 02139

***************************************************************************************
Generic Name Approved Orphan Indication:
2-(3-diethylaminopropyl)-8,8-dipropyl-2-azaspiro [4,5]
decan dimaleate

Trade Name:
Atiprimod Orphan Designation:
Treatment of mulitple myeloma and associated bone resorption

Designation
12/2/2003 Sponsor and Address
Marketing Exclusivity Callisto Pharmaceuticals, Inc.
2 Executive Drive
Suite 450
Somerset NJ 08873
***************************************************************************************
Generic Name Approved Orphan Indication:
2-(3-Diethylaminopropyl)-8,8-dipropyl-2-azaspiro[4,5]
decane dimaleate

Trade Name:
Atiprimod Orphan Designation:
Treatment of carcinoid tumors

Designation
9/18/2006 Sponsor and Address
Marketing Exclusivity Callisto Pharmaceuticals, Inc.
420 Lexington Avenue
New York NY 10170

***************************************************************************************
Generic Name Approved Orphan Indication:
2',3',5'-tri-o-acetyluridine

Trade Name:
Orphan Designation:
Treatment of mitochondrial disease

Designation
1/13/2003 Sponsor and Address
Marketing Exclusivity Repligen Corporation
41 Seyon Street
Building 1, Suite 100
Waltham MA 02453
***************************************************************************************
Generic Name Approved Orphan Indication:
2-0-Butyryl-1-0-octyl-myo-inositol 3,4,5,6-
tetrakisphosphate

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis

Designation
8/15/2003 Sponsor and Address
Marketing Exclusivity Inologic, Inc.
101 Elliott Ave., West
Seattle WA 98119

***************************************************************************************
Generic Name Approved Orphan Indication:
2-0-desulfated heparin

Trade Name:
Aeropin Orphan Designation:
Treatment of cystic fibrosis.

Designation
9/17/1993 Sponsor and Address
Marketing Exclusivity Kennedy & Hoidal, M.D.'s
University of Utah Health Sciences Center
50 North Medical Drive, Room 4R240
Salt Lake City UT 84132
***************************************************************************************
Generic Name Approved Orphan Indication:
20-mer complementary to Akt mRNA

Trade Name:
Orphan Designation:
Treatment of stomach cancer

Designation
12/10/2004 Sponsor and Address
Marketing Exclusivity Rexahn Corporation
9620 Medical center Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
20-mer oligonucleotide complementary to Akt mRNA

Trade Name:
Orphan Designation:
Treatment of pancreatic cancer

Designation
12/8/2004 Sponsor and Address
Marketing Exclusivity Rexahn Corporation
9620 Medical Center Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
20-mer oligonucleotide complementary to Akt mRNA

Trade Name:
Orphan Designation:
Treatment of glioblastoma

Designation
12/8/2004 Sponsor and Address
Marketing Exclusivity Rexahn Corporation
9620 Medical center Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
20-mer oligonucleotide complementary to Akt mRNA

Trade Name:
Orphan Designation:
Treatment of renal cell carcinoma

Designation
12/1/2004 Sponsor and Address
Marketing Exclusivity Rexahn Corporation
9620 Medical Center Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
20-mer oligonucleotide complementary to Akt mRNA

Trade Name:
Orphan Designation:
Treatment of ovarian cancer

Designation
12/1/2004 Sponsor and Address
Marketing Exclusivity Rexahn Corporation
9620 Medical Center Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
2'-3'-dideoxyadenosine

Trade Name:
Orphan Designation:
Treatment of aquired immunodeficiency syndrome.

Designation
7/21/1987 Sponsor and Address
Marketing Exclusivity National Cancer Institute, Dct
NIH, Exec. Plaza N., Room 7-18
Bethesda MD 20892

***************************************************************************************
Generic Name Approved Orphan Indication:
24,25 dihydroxycholecalciferol

Trade Name:
Orphan Designation:
Treatment of uremic osteodystrophy.

Designation
2/27/1987 Sponsor and Address
Marketing Exclusivity Lemmon Company
1510 Delp Drive
Kulpsville PA 19443

***************************************************************************************
Generic Name Approved Orphan Indication:
2-chloroethyl-3-sarcosinamide-1-nitrosourea

Trade Name:
Orphan Designation:
Treatment for malignant gliomas

Designation
8/3/2001 Sponsor and Address
Marketing Exclusivity Lawrence Panasci, MD
Professor of Medicine, McGill University
3755 Cote Ste Catherine
Montreal, Quebec H3T 1E2
CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
2-chloroethyl-3-sarcosinamide-1-nitrosourea

Trade Name:
Sarmustine Orphan Designation:
Treatment for malignant glioma

Designation
11/15/2001 Sponsor and Address
Marketing Exclusivity Pangene Corporation
5500 Stewart Avenue
Fremont CA 94538

***************************************************************************************
Generic Name Approved Orphan Indication:
2'-deoxycytidine

Trade Name:
Orphan Designation:
As a host-protective agent in the treatment of acute myelogenous
leukemia.
Designation
9/9/1996 Sponsor and Address
Marketing Exclusivity Grant, Steven M.D.
Massey Cancer Center, VCU
P.O. Box 980230
Richmond VA 23298-0230
***************************************************************************************
Generic Name Approved Orphan Indication:
2-methoxyestradiol

Trade Name:
PulmoLAR Orphan Designation:
Treatment of pulmonary arterial hypertension

Designation
4/11/2005 Sponsor and Address
Marketing Exclusivity PR Pharmaceuticals, Inc.
1716 Heath Parkway
Fort Collins CO 80524

***************************************************************************************
Generic Name Approved Orphan Indication:
2-methoxyestradiol

Trade Name:
Panzem NCD Orphan Designation:
Treatment of ovarian cancer

Designation
4/4/2005 Sponsor and Address
Marketing Exclusivity EntreMed, Inc.
9640 Medical Center Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
2-methoxyestradiol

Trade Name:
Panzem Orphan Designation:
Treatment of multiforme glioblastoma

Designation
6/16/2006 Sponsor and Address
Marketing Exclusivity EntreMed, Inc.
9640 Medical Center Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
2-methoxyestradiol

Trade Name:
Panzem Orphan Designation:
Treatment of multiple myeloma

Designation
7/10/2001 Sponsor and Address
Marketing Exclusivity EntreMed, Inc.
9640 Medical Center Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
2'-O-methyl-phosphorothiolate oliogribonucleotide

Trade Name:
Orphan Designation:
Treatment of Duchenne muscular dystrophy

Designation
11/18/2005 Sponsor and Address
Marketing Exclusivity Prosena B.V.
Einsteinweg 55

NETHERLANDS
***************************************************************************************
Generic Name Approved Orphan Indication:
3-(3,5-Dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-
2-one
Trade Name:
Orphan Designation:
Treatment of von Hippel-Lindau disease.

Designation
3/23/2000 Sponsor and Address
Marketing Exclusivity Sugen, Inc.
230 East Grand Ave.
South San Francisco CA 94080

***************************************************************************************
Generic Name Approved Orphan Indication:
3-(3,5-dimethyl-1H-2ylmethylene)-1,3-dihydro-indol-
2-one
Trade Name:
Orphan Designation:
Treatment of Kaposi's sarcoma.

Designation
9/11/1998 Sponsor and Address
Marketing Exclusivity Sugen, Inc.
230 East Grand Ave.
South San Francisco CA 94080-4811

***************************************************************************************
Generic Name Approved Orphan Indication:
3,4-diaminopyridine

Trade Name:
Orphan Designation:
Treatment of Lambert-Eaton myasthenic syndrome.

Designation
12/18/1990 Sponsor and Address
Marketing Exclusivity Jacobus Pharmaceutical Company
37 Cleveland Avenue
P.O. Box 5290
Princeton NJ 08540
***************************************************************************************
Generic Name Approved Orphan Indication:
3,5,3'-triiodothyroacetate

Trade Name:
Orphan Designation:
Treatment of well-differentiated papillary, follicular or combined
papillary/follicular carcinomas of the thyroid gland.
Designation
9/20/2000 Sponsor and Address
Marketing Exclusivity Elliot Danforth, Jr., M.D.
University of Vermont
84 Beartown Road
Underhill VT 05489
***************************************************************************************
Generic Name Approved Orphan Indication:
3'-azido-2',3'dideoxyuridine

Trade Name:
AZDU Orphan Designation:
Treatment of acquired immunodeficiency syndrome.

Designation
11/20/1989 Sponsor and Address
Marketing Exclusivity Berlex Laboratories, Inc.
1401 Harbor Bay Parkway
Alameda CA 94501

***************************************************************************************
Generic Name Approved Orphan Indication:
4-(2-fluorophenyl)-6-methyl-2-(1-piperzinyl)

Trade Name:
Orphan Designation:
Treatment of Chronic Functional Vomiting to include functional
vomiting and cyclic vomiting syndrome.
Designation
10/11/2006 Sponsor and Address
Marketing Exclusivity Dynogen Pharmaceuticals, Inc.
52 Second Avenue
Waltham MA 02451

***************************************************************************************
Generic Name Approved Orphan Indication:
4-(3-Methanesulfonyl-phenyl)-1-propylpiperidine HCl

Trade Name:
Orphan Designation:
Treatment of Huntington disease.

Designation
12/12/2005 Sponsor and Address
Marketing Exclusivity A. Carlsson Research AB
Joakim Tedroff, M.D.
S-412 46 Goteborg

SWEDEN
***************************************************************************************
Generic Name Approved Orphan Indication:
4,5-dibromorhodamine 123

Trade Name:
Theralux Irradiation Device Orphan Designation:
Treatment of chronic myelogenous leukemia

Designation
4/10/2003 Sponsor and Address
Marketing Exclusivity Kiadis Pharma Canada, Inc.
2525 Marie-Curie
Saint-Laurent (Quebec) H4S 2E1

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
40SD02

Trade Name:
Orphan Designation:
Treatment of chronic iron overload resulting from conventional
transfusional treatment of beta-thalassemia major and sickle cell
Designation anemia.
12/21/1998 Sponsor and Address
Marketing Exclusivity Biomedical Frontiers, Inc.
1095 10th Ave., S.E.
Minneapolis MN 55414

***************************************************************************************
Generic Name Approved Orphan Indication:
4-Amino-1-[5-O-[(2R, 4S)-2-oxido-4-(4-pyridinyl)-1, 3,
2-dioxaphosphorinan-2-yl]-b-D-arabinofuranosyl]-
2(1H)-pyrimidinone

Trade Name:
Orphan Designation:
Treatment of hepatocellular carcinoma.

Designation
8/22/2007 Sponsor and Address
Marketing Exclusivity Metabasis Therapeutics, Incorporated
11119 North Torrey Pines Road
LaJolla CA 92037

***************************************************************************************
Generic Name Approved Orphan Indication:
4-Aminopyridine

Trade Name:
Orphan Designation:
Treatment chronic functional motor and sensory deficits from
Guillain-Barre syndrome
Designation
12/14/2005 Sponsor and Address
Marketing Exclusivity Neurorecovery, Inc.
Crescent Center
Suite 930
Memphis TN 38119
***************************************************************************************
Generic Name Approved Orphan Indication:
4-aminosalicylic acid

Trade Name:
Paser Granules Orphan Designation:
Treatment of acute flares in pediatric patients with ileo-cecal Crohn's
disease
Designation
4/26/2006 Sponsor and Address
Marketing Exclusivity Jacobus Pharmaceutical Co., Inc.
37 Cleveland Lane
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
4-aminosalicylic acid

Trade Name:
Pamisyl (P-D), Rezipas (Squibb) Orphan Designation:
Treatment of mild to moderate ulcerative colitis in patients intolerant
to sulfasalazine.
Designation
12/13/1989 Sponsor and Address
Marketing Exclusivity Beeken, Warren M.D.
University Of Vermont
Given C-317
Burlington VT 05405
***************************************************************************************
Generic Name Approved Orphan Indication:
4-cholest-en-3-one, oxime

Trade Name:
Orphan Designation:
Treatment of amyotrophic lateral sclerosis

Designation
12/1/2005 Sponsor and Address
Marketing Exclusivity Trophos SA
Parc scientifique de Lumigny, Case 931
1322 Marseille cedex

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
4-cyano-N-[2-(1-cyclohexen-1-yl)-4-[1-
[dimethylamino)acetyl]-4-piperidinyl]phenyl]-1H-
imidazole-2-carboxamide monohydrochloride

Trade Name:
Orphan Designation:
Treatment of acute myeloid leukemia

Designation
7/20/2006 Sponsor and Address
Marketing Exclusivity Johnson & Johnson Pharmaceutical Research & Dev,
920 U S Highway 202
P.O. Box 300
Raritan NJ 08869
***************************************************************************************
Generic Name Approved Orphan Indication:
4-trifluoromethyl-N-(3.3a.4.4a.5,5a,6,6a-octahydro-
1,3-dioxo-4,6ethenocycloprop[f]isoindol-2(1H)-yl)-

Trade Name:
Orphan Designation:
Treatment of smallpox.

Designation
12/27/2006 Sponsor and Address
Marketing Exclusivity SIGA Technologies, Inc.
4575 SW Research Way
Corvallis OR 97333

***************************************************************************************
Generic Name Approved Orphan Indication:
4-trifluoromethyl-N-(3.3a.4.4a.5,5a,6,6a-octahydro-
1,3-dioxo-4,6ethenocycloprop[f]isoindol-2(1H)-yl)-

Trade Name:
Orphan Designation:
post exposure prophylaxis against smallpox

Designation
12/18/2006 Sponsor and Address
Marketing Exclusivity SIGA Technologies, Inc.
4575 SW Research Way
Corvallis OR 97333

***************************************************************************************
Generic Name Approved Orphan Indication:
5(S)-(2'-hydroxy ethoxy)-20(S)-Camptothecin

Trade Name:
Orphan Designation:
Treatment of osteosarcoma (bone cancer)

Designation
6/15/2007 Sponsor and Address
Marketing Exclusivity ClinTec International Ltd.
1055 Westlakes Drive
Berwyn PA 19312

***************************************************************************************
Generic Name Approved Orphan Indication:
5,12-Naphthacenedione, 10-[[3-amino-2,3,6-trideoxy-
4-O-(phenylmethyl)-a-L-lyxo-hexopyranosyl]oxy]-
7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-
(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S,10S)-

Trade Name:
Orphan Designation:
Treatment of malignant gliomas

Designation
10/11/2006 Sponsor and Address
Marketing Exclusivity Reata Pharmaceuticals, Inc.
1950 N. Stemmons Freeway
Dallas TX 75207-3199

***************************************************************************************
Generic Name Approved Orphan Indication:
5,5',5"-[Phosphinothioylidyne-tris(imino-2,1-
ethanediyl)]tris[5-methylchelidoninium]trihydroide
hexahydrochloride

Trade Name:
Orphan Designation:
Treatment of pancreatic cancer

Designation
8/20/2003 Sponsor and Address
Marketing Exclusivity Now Pharm AG
241, route d'Arlon
L-1150

LUXEMBOURG
***************************************************************************************
Generic Name Approved Orphan Indication:
5,6-dihydro-5-azacytidine

Trade Name:
Orphan Designation:
Treatment of malignant mesothelioma.

Designation
5/11/1992 Sponsor and Address
Marketing Exclusivity ILEX Oncology, Inc.
4545 Horizon Hill Blvd.
San Antonio TX 78229-2263

***************************************************************************************
Generic Name Approved Orphan Indication:
5,7-dihydroxy-3-(4-hydroxyphenyl)-chromen-4-one

Trade Name:
Orphan Designation:
Prevention of acute radiation syndrome

Designation
6/18/2007 Sponsor and Address
Marketing Exclusivity Humanetics, Inc.
10400 Viking Drive
Eden Prairie MN 55344

***************************************************************************************
Generic Name Approved Orphan Indication:
506U78

Trade Name:
Orphan Designation:
Treatment of chronic lymphocytic leukemia.

Designation
9/2/1999 Sponsor and Address
Marketing Exclusivity GlaxoSmithKline
Five Moore Dr.
P.O. Box 13398
Research Triangle Park NC 27709-3398
***************************************************************************************
Generic Name Approved Orphan Indication:
5a8, monoclonal antibody to CD4

Trade Name:
Orphan Designation:
For use in post-exposure prophylaxis for occupational exposure to
human immunodeficiency virus.
Designation
12/20/1993 Sponsor and Address
Marketing Exclusivity Biogen, Inc.
14 Cambridge Center
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
5-aza-2'-deoxycytidine

Trade Name:
Orphan Designation:
Treatment of acute leukemia.

Designation
8/3/1987 Sponsor and Address
Marketing Exclusivity SuperGen, Inc.
4140 Dublin Blvd.
Suite 200
Dublin CA 94568
***************************************************************************************
Generic Name Approved Orphan Indication:
5-hydroxymethyl-2-furfuraldehyde

Trade Name:
Orphan Designation:
Treatment of sickle cell disease

Designation
5/26/2006 Sponsor and Address
Marketing Exclusivity Xechem International, Inc.
New Brunswick Technoloogy Center
Building 1, Suite 310
New Brunswick NJ 08901-3279
***************************************************************************************
Generic Name Approved Orphan Indication:
5-iodo-2-pytimidinone-2'-deoxyribose

Trade Name:
Orphan Designation:
Treatment of malginant glioma

Designation
5/26/2006 Sponsor and Address
Marketing Exclusivity Hana Biosciences, Inc.
7000 Shoreline Court
Suite 370
South San Francisco CA 94080
***************************************************************************************
Generic Name Approved Orphan Indication:
5-methyl-1-phenyl-2-(1H)-pyridone(CAS 53179-13-8)

Trade Name:
Pirfenidone Orphan Designation:
Treatment of idiopathic pulmonary fibrosis

Designation
3/5/2004 Sponsor and Address
Marketing Exclusivity InterMune, Inc.
3280 Bayshore Blvd
Brisbane CA 94005

***************************************************************************************
Generic Name Approved Orphan Indication:
6,8-bis-benzylsulfanyl-octanoic acid

Trade Name:
Orphan Designation:
Treatment of pancreatic cancer

Designation
2/6/2006 Sponsor and Address
Marketing Exclusivity Cornerstone Pharmaceuticals, Inc.
25 Health Science Drive
Stony Brook NY 11790

***************************************************************************************
Generic Name Approved Orphan Indication:
6-hydroxymethylacylfulvene

Trade Name:
Orphan Designation:
Treatment of histologically confirmed advanced or metastatic
pancreatic cancer.
Designation
4/6/1999 Sponsor and Address
Marketing Exclusivity MGI Pharma, Inc.
5775 West Old Shakopee
Suite 100
Bloomington MN 55437-3107
***************************************************************************************
Generic Name Approved Orphan Indication:
8 Cyclopentyl 1,3-dipropylxanthine

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis.

Designation
3/24/1997 Sponsor and Address
Marketing Exclusivity SciClone Pharmaceuticals, Inc.
901 Mariner's Island Boulevard
San Mateo CA 94404-1593

***************************************************************************************
Generic Name Approved Orphan Indication:
8-methoxsalen

Trade Name:
Uvadex Orphan Designation:
For use in conjunction with the UVAR photopheresis to treat diffuse
systemic sclerosis.
Designation
6/22/1993 Sponsor and Address
Marketing Exclusivity Therakos, Inc.
Oaklands Corporate Center
437 Creamery Way
Exton PA 19341
***************************************************************************************
Generic Name Approved Orphan Indication:
8-methoxsalen

Trade Name:
Uvadex Orphan Designation:
For the prevention of acute rejection of cardiac allografts.

Designation
5/12/1994 Sponsor and Address
Marketing Exclusivity Therakos, Inc.
Oaklands Corporate Center
437 Creamery Way
Exton PA 19341
***************************************************************************************
Generic Name Approved Orphan Indication:
90Y-hPAMA4

Trade Name:
PAN-Cide Orphan Designation:
Treatment of pancreatic cancer

Designation
1/29/2004 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
9-cis-retinoic acid

Trade Name:
Orphan Designation:
Prevention of retinal detachment due to proliferative
vitreoretinopathy.
Designation
1/2/1997 Sponsor and Address
Marketing Exclusivity Allergan, Inc.
2525 Dupont Drive
P.O. Box 19534
Irvine CA 92623-9534
***************************************************************************************
Generic Name Approved Orphan Indication:
9-nitro-20-(S)-camptothecin

Trade Name:
Orphan Designation:
Treatment of pancreatic cancer.

Designation
9/16/1996 Sponsor and Address
Marketing Exclusivity SuperGen, Inc.
4140 Dublin Blvd.
Suite 200
Dublin CA 94568
***************************************************************************************
Generic Name Approved Orphan Indication:
9-nitro-20-(S)-camptothecin Treatment of pediatric HIV-infection/AIDS patients

Trade Name:
Camvirex Orphan Designation:
Treatment of pediatric HIV infection/AIDS

Designation
5/15/2001 Sponsor and Address
Marketing Exclusivity NovoMed Pharmaceuticals, Inc.
P.O. Box 900
Germantown MD 20875-0900

***************************************************************************************
Generic Name Approved Orphan Indication:
a-(3-aminophthalimido) glutaramide

Trade Name:
Actimid Orphan Designation:
Treatment of multiple myeloma

Designation
1/15/2003 Sponsor and Address
Marketing Exclusivity Celgene Corporation

7 Powder Horn Drive


Warren NJ 07059
***************************************************************************************
Generic Name Approved Orphan Indication:
A10 & AS2-1 Antineoplaston

Trade Name:
Orphan Designation:
Treatment for patients with brain stem glioma

Designation
9/3/2004 Sponsor and Address
Marketing Exclusivity Burzynski Research Institute, Inc.
9432 Old Katy Road
Houston TX 77055

***************************************************************************************
Generic Name Approved Orphan Indication:
Abetimus

Trade Name:
Orphan Designation:
Treatment of lupus nephritis.

Designation
7/28/2000 Sponsor and Address
Marketing Exclusivity La Jolla Pharmaceutical Co.
6455 Nancy Ridge Dr.
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
ACA125

Trade Name:
Orphan Designation:
Treatment of epithelial ovarian cancer

Designation
11/25/2003 Sponsor and Address
Marketing Exclusivity Menarini Ricerche S.p.A.
Via Tito Speri 10
Pomezia Roma

ITALY
***************************************************************************************
Generic Name Approved Orphan Indication:
Acetylcysteine

Trade Name:
Mucomyst/Mucomyst 10 IV Orphan Designation:
Intravenous treatment of patients presenting with moderate to severe
acetaminophen overdose.
Designation
8/13/1987 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Company
P.O. Box 4500
Princeton NJ 08543-4500

***************************************************************************************
Generic Name Approved Orphan Indication:
acetylcysteine For the use of Acetadote(registered TM) Injection, administered
intravenously within 8 to 10 hours after ingestion of a potentially
heptotoxic quantity of acetaminophen, to prevent or lessen hepatic
Trade Name: injur
Acetadote Orphan Designation:
For the intravenous treatment of moderate to severe acetaminophen
overdose
Designation
10/19/2001 Sponsor and Address
Marketing Exclusivity Cumberland Pharmaceuticals, Inc.
1/23/2004 209 10th Street South
Suite 332
Nashville TN 37203
***************************************************************************************
Generic Name Approved Orphan Indication:
Acid sphingomyelinase

Trade Name:
Orphan Designation:
Treatment of Niemann-Pick disease type B.

Designation
8/3/2000 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
500 Kendall Street
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Aconiazide

Trade Name:
Orphan Designation:
Treatment of tuberculosis.

Designation
6/20/1988 Sponsor and Address
Marketing Exclusivity Lincoln Diagnostics
P.O. Box 1128
Decatur IL 62525

***************************************************************************************
Generic Name Approved Orphan Indication:
Adalimumab

Trade Name:
Humira Orphan Designation:
Treatment of pediatric Crohn's disease.

Designation
10/19/2006 Sponsor and Address
Marketing Exclusivity Abbott Laboratories
200 Abbott Park Road
Abbott Park IL 60064-6188

***************************************************************************************
Generic Name Approved Orphan Indication:
Adalimumab

Trade Name:
Humira Orphan Designation:
Treatment of juvenile rheumatoid arthritis

Designation
3/21/2005 Sponsor and Address
Marketing Exclusivity Abbott Laboratories
200 Abbott Park Road
Abbott Park IL 60064-6157

***************************************************************************************
Generic Name Approved Orphan Indication:
Adeno-associated vector expressing the human
lipoprotein lipase protein

Trade Name:
Orphan Designation:
Treatment of lipoprotein lipase deficiency

Designation
5/21/2007 Sponsor and Address
Marketing Exclusivity Amsterdam Molecular Therapeutics BV
P. O. Box 22506

NETHERLANDS
***************************************************************************************
Generic Name Approved Orphan Indication:
Adeno-associated viral vector containing the gene for
human coagulation factor IX

Trade Name:
Coagulin-B Orphan Designation:
Intramuscular treatment of patients with moderate to severe
hemophilia
Designation
6/13/2001 Sponsor and Address
Marketing Exclusivity Avigen, Inc.
1301 Harbor Bay Parkway
Alameda CA 94502

***************************************************************************************
Generic Name Approved Orphan Indication:
Adeno-associated viral vector containing the gene for
human coagulation factor IX

Trade Name:
Coagulin-B Orphan Designation:
Intrahepatic treatment of patients with moderate to severe
hemophilia
Designation
6/13/2001 Sponsor and Address
Marketing Exclusivity Avigen, Inc.
1301 Harbor Bay Parkway
Alameda CA 94502

***************************************************************************************
Generic Name Approved Orphan Indication:
Adeno-associated viral vector expressing human acid
alpha glucosidase gene

Trade Name:
Orphan Designation:
Treatment for Pompe disease

Designation
3/20/2007 Sponsor and Address
Marketing Exclusivity Applied Genetic Technologies Corporation
11801 Research Drive
Alachua FL 32615

***************************************************************************************
Generic Name Approved Orphan Indication:
adeno-associated viral vector expressing human
retinoschisin-1 gene

Trade Name:
Orphan Designation:
Treatment of X-linked juvenile retinoschisis (XLRS).

Designation
5/21/2007 Sponsor and Address
Marketing Exclusivity Applied Genetic Technologies Corporation
11801 Research Drive
Alachua FL 32615

***************************************************************************************
Generic Name Approved Orphan Indication:
Adeno-associated viral-based vector cystic fibrosis
gene therapy

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis.

Designation
2/15/1995 Sponsor and Address
Marketing Exclusivity Targeted Genetics Corporation
1100 Olive Way, Suite 100
Seattle WA 98101

***************************************************************************************
Generic Name Approved Orphan Indication:
Adenosine

Trade Name:
Orphan Designation:
For use in conjunction with BCNU in the treatment of brain tumors.

Designation
8/1/1989 Sponsor and Address
Marketing Exclusivity Medco Research, Inc.
8455 Beverly Boulevard
Suite 308
Los Angeles CA 90048
***************************************************************************************
Generic Name Approved Orphan Indication:
Adenoviral vector expressing Herpes simplex virus
thymidine kinase gene

Trade Name:
Orphan Designation:
Treatment of malignant brain tumors

Designation
6/17/2005 Sponsor and Address
Marketing Exclusivity Advantagene, Inc.
160 Paulson Road
Waban MA 02468

***************************************************************************************
Generic Name Approved Orphan Indication:
Adenovirus-based vector Factor VIII complementary
DNA to somatic cells

Trade Name:
MiniAdFVIII Orphan Designation:
Treatment of hemophilia A.

Designation
12/15/1999 Sponsor and Address
Marketing Exclusivity GenStar Therapeutics Corporation
10835 Altman Row
Suite 150
San Diego CA 92121
***************************************************************************************
Generic Name Approved Orphan Indication:
adenovirus-mediated herpes simplex virus-thymidine
kinase gene

Trade Name:
Orphan Designation:
Use with gancyclovir in the treatment of malignant glioma

Designation
7/31/2001 Sponsor and Address
Marketing Exclusivity Ark Therapeutics Ltd
6 Warren Mews
London W1T6AR
London
UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Aerosolized pooled immune globulin

Trade Name:
Orphan Designation:
Treatment of respiratory syncytial virus lower respiratory tract disease.

Designation
1/3/1989 Sponsor and Address
Marketing Exclusivity Pediatric Pharmaceuticals, Inc.
718 Bradford Avenue
Westfield NJ 07090

***************************************************************************************
Generic Name Approved Orphan Indication:
a-Galactosidase A

Trade Name:
Plant-Produced Human a-Glactosidase A Orphan Designation:
Treatment of Fabry's disease

Designation
1/21/2003 Sponsor and Address
Marketing Exclusivity Large Scale Biology Corporation
3333 Vacaville Parkway
Suite 1000
Vacaville CA 95688
***************************************************************************************
Generic Name Approved Orphan Indication:
Aglycosyl anti-CD3 monoclonal antibody

Trade Name:
Orphan Designation:
Treatment of new-onset type I diabetes mellitus

Designation
2/6/2006 Sponsor and Address
Marketing Exclusivity TolerRX, Inc.
300 Technology Square
Cambridge MA 02139

***************************************************************************************
Generic Name Approved Orphan Indication:
AI-RSA

Trade Name:
Orphan Designation:
Treatment of autoimmune uveitis.

Designation
10/8/1992 Sponsor and Address
Marketing Exclusivity AutoImmune, Inc.
128 Spring Street
Lexington MA 02173

***************************************************************************************
Generic Name Approved Orphan Indication:
Albendazole Treatment of parenchymal neurocysticercosis due to active lesions
caused by larval forms of the pork tapeworm, Taenia solium.

Trade Name:
Albenza Orphan Designation:
Treatment of neurocysticercosis due to Taenia solium as: 1)
chemotherapy of parenchymal, subarachnoidal and racemose (cysts
Designation in spinal fluid) neurocysticercosis in symptomatic cases and 2)
1/18/1996 prophylaxis of epilepsy and other sequelae in asymptomatic
Sponsor and Address
Marketing Exclusivity SmithKline Beecham Pharmaceuticals
6/11/1996 One Franklin Plaza
P.O. Box 7929
Philadelphia PA 19101
***************************************************************************************
Generic Name Approved Orphan Indication:
Albendazole Treatment of cystic hydatid disease of the liver, lung, and
peritoneum, caused by the larval form of the dog tapeworm,
Echinococcus granulosus.
Trade Name:
Albenza Orphan Designation:
Treatment of hydatid disease (cystic echinococcosis due to E.
granulosus larvae or alveolar echinococcosis due to E. multilocularis
Designation larvae).
1/17/1996 Sponsor and Address
Marketing Exclusivity SmithKline Beecham Pharmaceuticals
6/11/1996 One Franklin Plaza
P.O. Box 7929
Philadelphia PA 19101
***************************************************************************************
Generic Name Approved Orphan Indication:
Albuterol

Trade Name:
Orphan Designation:
Prevention of paralysis due to spinal cord injury

Designation
3/12/2002 Sponsor and Address
Marketing Exclusivity MotoGen, Inc.
3 Pine View Road
Mount Kisco NY 10549

***************************************************************************************
Generic Name Approved Orphan Indication:
Aldesleukin

Trade Name:
Proleukin Orphan Designation:
Treatment of primary immunodeficiency disease associated with T-
cell defects.
Designation
3/22/1989 Sponsor and Address
Marketing Exclusivity Chiron Corporation
4560 Horton Street
Emeryville CA 94608-2916

***************************************************************************************
Generic Name Approved Orphan Indication:
Aldesleukin Treatment of adults (>18 years old) with metastatic renal cell
carcinoma.

Trade Name:
Proleukin Orphan Designation:
Treatment of metastatic renal cell carcinoma.

Designation
9/14/1988 Sponsor and Address
Marketing Exclusivity Chiron Corporation
5/5/1992 4560 Horton Street
Emeryville CA 94608-2916

***************************************************************************************
Generic Name Approved Orphan Indication:
Aldesleukin Treatment of adults with metastatic melanoma.

Trade Name:
Proleukin Orphan Designation:
Treatment of metastatic melanoma.

Designation
9/10/1996 Sponsor and Address
Marketing Exclusivity Chiron Corporation
1/9/1998 4560 Horton Street
Emeryville CA 94608-2916

***************************************************************************************
Generic Name Approved Orphan Indication:
Aldesleukin

Trade Name:
Proleukin Orphan Designation:
For the treatment non-Hodgkin's lymphoma.

Designation
11/24/1998 Sponsor and Address
Marketing Exclusivity Chiron Corporation
4560 Horton St.
Emeryville CA 94608-2916

***************************************************************************************
Generic Name Approved Orphan Indication:
alemtuzumab The treatment of patients with B-cell chronic lymphocytic leukemia
who have been treated with alkylating agents and who have failed
fludarabine therapy.
Trade Name:
Campath Orphan Designation:
Treatment of chronic lymphocytic leukemia.

Designation
10/20/1997 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
5/7/2001 4545 Horizon Hill Blvd.
San Antonio TX 78229-2263

***************************************************************************************
Generic Name Approved Orphan Indication:
alendronate

Trade Name:
Fosamax Orphan Designation:
Treatment of osteogenesis imperfecta in pediatric patients 4 years of
age and older
Designation
3/31/2003 Sponsor and Address
Marketing Exclusivity Merck & Co., Inc.
126 East Lincoln Ave.
Rahway NJ 07065-0900

***************************************************************************************
Generic Name Approved Orphan Indication:
Alendronate disodium

Trade Name:
Fosamax Orphan Designation:
Treatment of the bone manifestations of Gaucher disease

Designation
2/13/2001 Sponsor and Address
Marketing Exclusivity Richard J. Wenstrup, M.D.
Division of Human Genetics
Children's Hospital Research Foundation
Cincinnati OH 45229-3039
***************************************************************************************
Generic Name Approved Orphan Indication:
Alfentanil

Trade Name:
Orphan Designation:
Management of postherpetic neuralgia

Designation
7/8/2005 Sponsor and Address
Marketing Exclusivity Cinergen, LLC
146 Medinah Drive
Blue Bell PA 19422-3212

***************************************************************************************
Generic Name Approved Orphan Indication:
Alfentanil

Trade Name:
Orphan Designation:
Treatment of painful HIV-associated neuropathy

Designation
8/9/2005 Sponsor and Address
Marketing Exclusivity Cinergen, LLC
146 Medinah Drive
Blue Bell PA 19422-3212

***************************************************************************************
Generic Name Approved Orphan Indication:
Alglucerase injection

Trade Name:
Ceredase Orphan Designation:
Replacement therapy in patients with Type II and III Gaucher's
disease.
Designation
7/21/1995 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
One Kendall Square
Cambridge MA 02139-1562

***************************************************************************************
Generic Name Approved Orphan Indication:
Alglucerase injection Long-term enzyme replacement therapy for children, adolescents and
adult patients with a confirmed diagnosis of Type I Gaucher disease
who
Trade Name: exhibit signs and symptoms that are severe enough to result in one or
more of the following conditions:
a) moderate-to-severe anemia;
b) thrombocytopenia with bleeding tendency;
c) bone disease;
Ceredase Orphan Designation:
For replacement therapy in patients with Gaucher's disease type I.

Designation
3/11/1985 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
4/5/1991 One Kendall Square
Cambridge MA 02139-1562

***************************************************************************************
Generic Name Approved Orphan Indication:
Alitretinoin Topical treatment of cutaneous lesions in patients with AIDS-related
Kaposi's sarcoma.

Trade Name:
Panretin Orphan Designation:
Topical treatment of cutaneous lesions in patients with AIDS-related
Kaposi's sarcoma.
Designation
3/24/1998 Sponsor and Address
Marketing Exclusivity Eisai Medical Research, Inc
2/2/1999 55 Challenger Road
Ridgefield Park NJ 07660

***************************************************************************************
Generic Name Approved Orphan Indication:
Alitretinoin

Trade Name:
Panretin Orphan Designation:
Treatment of acute promyelocytic leukemia

Designation
4/10/1992 Sponsor and Address
Marketing Exclusivity Ligand Pharmaceuticals, Inc.
10275 Science Center Dr.
San Diego CA 92121-1117

***************************************************************************************
Generic Name Approved Orphan Indication:
allantoin

Trade Name:
Alwextin Orphan Designation:
Treatment of skin blistering and erosions associated with inherited
epidermolysis bullosa
Designation
11/21/2002 Sponsor and Address
Marketing Exclusivity Alwyn Company, Inc.
2301 Highway 60 East
Lake Crystal MN 56055

***************************************************************************************
Generic Name Approved Orphan Indication:
Allogeneic human retinal pigment epithelial cells on
gelatin microcarriers

Trade Name:
Spheramine Orphan Designation:
Treatment of Hoehn and Yahr stage 3 and 4 Parkinson's disease.

Designation
7/18/1997 Sponsor and Address
Marketing Exclusivity Bayer Healthcare Pharmaceuticals, Inc.
Post Office Box 1000
50 Division Street, Suite 503
Montville NJ 07045-1000
***************************************************************************************
Generic Name Approved Orphan Indication:
Allogeneic peripheral blood mononuclear cells
sensitized against patient alloantigens by mixed

Trade Name:
CYTOIMPLANT Orphan Designation:
Treatment of pancreatic cancer

Designation
6/13/1997 Sponsor and Address
Marketing Exclusivity Applied Immunotherapeutics, LLC
14132 E. Firestone Boulevard
Santa Fe Springs CA 90670

***************************************************************************************
Generic Name Approved Orphan Indication:
Allogeneic retinal epithelial cells transfected with
plasmid vector expressing ciliary neurotrophic growth

Trade Name:
Orphan Designation:
Treatment of retinitis pigmentosa

Designation
9/1/2004 Sponsor and Address
Marketing Exclusivity Neurotech USA, Inc.
6 Blackstone Valley Place
Lincoln RI 02865

***************************************************************************************
Generic Name Approved Orphan Indication:
Allogeneic T-cells cultured with anti-CD3 and IL-2;
transduced with retroviral vector (SFCMM-3),
expressing herpes simplex 1 virus-thymidine kinase
(HSV-TK) and truncated low affinity nerve growth
factor receptor; selected with anti-low affinity nerve gro

Trade Name:
Orphan Designation:
Immunotherapy for acceleration of T-cell reconstitution in patients
undergoing allogeneic hematopoietic stem cell transplantation
Designation
1/28/2005 Sponsor and Address
Marketing Exclusivity MolMed S.p.A.
Via Olgettina 58
Milan 20132

ITALY
***************************************************************************************
Generic Name Approved Orphan Indication:
Allopurinol riboside

Trade Name:
Orphan Designation:
Treatment of cutaneous and visceral leishmaniasis.

Designation
12/4/1985 Sponsor and Address
Marketing Exclusivity Burroughs Wellcome Company
3030 Cornwallis Road
P.O. Box 12700
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Allopurinol riboside

Trade Name:
Orphan Designation:
Treatment of Chagas' disease.

Designation
12/4/1985 Sponsor and Address
Marketing Exclusivity Burroughs Wellcome Company
3030 Cornwallis Road
P.O. Box 12700
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Allopurinol sodium Management of patients with leukemia, lymphoma, and solid tumor
malignancies who are receiving cancer therapy which causes
elevations of serum and urinary uric acid levels and who cannot
Trade Name: tolerate oral therapy.
Aloprim for Injection Orphan Designation:
Management of patients with leukemia, lymphoma, and solid tumor
malignancies who are receiving cancer therapy which causes
Designation elevations of serum and urinary uric acid levels and who cannot
10/16/1992 Sponsor and Address tolerate oral therapy.
Marketing Exclusivity Catalytica Pharmaceuticals, Inc
5/17/1996 PO Box 1887
Greenville NC 27835-1887

***************************************************************************************
Generic Name Approved Orphan Indication:
Allopurinol sodium

Trade Name:
Orphan Designation:
Ex-vivo preservation of cadaveric kidneys for transplantation

Designation
11/9/1987 Sponsor and Address
Marketing Exclusivity Burroughs Wellcome Company
3030 Cornwallis Road
Research Triangle Pk NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha-1-acid glycoprotein

Trade Name:
Orphan Designation:
Treatment of cocaine overdose

Designation
3/5/2004 Sponsor and Address
Marketing Exclusivity Bio Products Laboratory
Dagger Lane, Elstree, Hertfordshire
WD6 3BX

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha-1-acid glycoprotein

Trade Name:
Orphan Designation:
Treatment of tricyclic antidepressant poisoning

Designation
3/17/2004 Sponsor and Address
Marketing Exclusivity Bio Products Laboratory
Dagger Lane
Elstree, Hertfordshire

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha-1-antitrypsin (recombinant DNA Origin)

Trade Name:
Orphan Designation:
As supplementation therapy for alpha-1-antitrypsin deficiency in the
ZZ phenotype population.
Designation
1/1/1984 Sponsor and Address
Marketing Exclusivity Chiron Corporation
4560 Horton Street
Emeryville CA 94608-2916

***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha1-Proteinase Inhibitor (Human)

Trade Name:
Orphan Designation:
Inhalation therapy for the the treatment of congential deficiency of
alpha1-proteinase inhibitor.
Designation
12/22/2004 Sponsor and Address
Marketing Exclusivity Kamada Ltd.
Kiryat Weizmann

ISRAEL
***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha1-Proteinase Inhibitor (Human)

Trade Name:
ARC-API Orphan Designation:
Treatment of cystic fibrosis

Designation
9/1/2004 Sponsor and Address
Marketing Exclusivity Kamada Ltd.
Kiryat Weizmann

ISRAEL
***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha1-proteinase inhibitor (human)

Trade Name:
Orphan Designation:
For slowing the progression of emphysema in alpha1-antitrypsin
deficient patients.
Designation
11/24/1999 Sponsor and Address
Marketing Exclusivity Aventis Behring L.L.C.
1020 First Ave.
PO Box 61501
King of Prussia PA 19406-0901
***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha1-proteinase inhibitor (human) For chronic replacement therapy of individuals having congenital
deficiency of alpha1- proteinase inhibitor with clinically
demonstrable panacinar emphysema.
Trade Name:
Prolastin Orphan Designation:
For replacement therapy in the alpha-1-proteinase inhibitor
congenital deficiency state.
Designation
12/7/1984 Sponsor and Address
Marketing Exclusivity Bayer Corporation
12/2/1987 Pharmaceutical Division, Biological Products
400 Morgan Lane
New Haven CT 06516
***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha-galactosidase A

Trade Name:
Fabrase Orphan Designation:
Treatment of Fabry's disease.

Designation
7/20/1990 Sponsor and Address
Marketing Exclusivity Desnick, Robert J. M.D.
The Mount Sinai School Of Medicine
Fifth Avenue at 100th Street, Box 1203
New York NY 10029
***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha-galactosidase A

Trade Name:
CC-galactosidase Orphan Designation:
Treatment of alpha-galactosidase A deficiency (Fabry's disease).

Designation
6/17/1991 Sponsor and Address
Marketing Exclusivity David Calhoun, Ph.D.
Department of Chemistry
Convent Avenue & 138th Street
New York NY 10031
***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha-galactosidase A

Trade Name:
Replagal Orphan Designation:
Long-term enzyme replacement therapy for the treatment of Fabry
disease.
Designation
6/22/1998 Sponsor and Address
Marketing Exclusivity Shire Human Genetic Therapies, Inc.
700 Main Street
Cambridge MA 02139

***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha-melanocyte stimulating hormone

Trade Name:
Orphan Designation:
Prevention and treatment of intrinsic acute renal failure due to
ischemia.
Designation
8/19/1997 Sponsor and Address
Marketing Exclusivity National Institute of Diabetes, and Digestive and Kidney Diseases
National Institutes of Health, 31 Center Drive MSC
Building 31, Room 9N-222
Bethesda MD 20892-2560
***************************************************************************************
Generic Name Approved Orphan Indication:
Alpha-tocopherol quinone

Trade Name:
Orphan Designation:
Treatment of inherited mitochondrial respiratory chain diseases

Designation
3/28/2006 Sponsor and Address
Marketing Exclusivity Penwest Pharmaceuticals Company
39 Old Ridgebury Road
Suite 11
Danbury CT 06810
***************************************************************************************
Generic Name Approved Orphan Indication:
Alprostadil

Trade Name:
Orphan Designation:
Treatment of severe peripheral arterial occlusive disease (critical limb
ischemia) in patients where other procedures, grafts or angioplasty,
Designation are not indicated.
10/20/1993 Sponsor and Address
Marketing Exclusivity Schwarz Pharma, Inc.
P.O. Box 2038
Milwaukee WI 53201

***************************************************************************************
Generic Name Approved Orphan Indication:
alteplase

Trade Name:
Activase Orphan Designation:
Treatment of intraventricular hemmorage associated with
intracerebral hemmorrhage
Designation
1/27/2003 Sponsor and Address
Marketing Exclusivity Daniel F. Hanley, MD
Johns Hopkins University
600 N. Wolfe St., Jefferson 1-109
Baltimore MD 21287
***************************************************************************************
Generic Name Approved Orphan Indication:
Altretamine Single agent palliative treatment of patients with persistent or
recurrent ovarian cancer following first-line therapy with a cisplatin
and/or alkylating agent based combination.
Trade Name:
Hexalen Orphan Designation:
Treatment of advanced adenocarcinoma of the ovary.

Designation
2/9/1984 Sponsor and Address
Marketing Exclusivity Medimmune Oncology, Inc.
12/26/1990 One Tower Bridge
100 Front Street, Suite 400
Conshohocken PA 19428
***************************************************************************************
Generic Name Approved Orphan Indication:
Alvocidib

Trade Name:
Orphan Designation:
Teatment of B-cell chronic lymphocytic leukemia (B-CLL) or
prolymphocytic leukemia arising from CLL.
Designation
4/13/2007 Sponsor and Address
Marketing Exclusivity Sanofi-Aventis US, Inc.
55 Corporate Drive
Bridgewater NJ 08807

***************************************************************************************
Generic Name Approved Orphan Indication:
ambrisentan Treatment of pulmonary arterial hypertension (WHO group I) in
patients with WHO class II or III symptoms to improve exercise
capacity and delay clinical worsening
Trade Name:
Letairis Orphan Designation:
Treatment of pulmonary arterial hypertension

Designation
7/16/2004 Sponsor and Address
Marketing Exclusivity Gilead Colorado
6/15/2007 7575 West 103rd Avenue
Suite 102
Westminister CO 80021-5426
***************************************************************************************
Generic Name Approved Orphan Indication:
AMG 531

Trade Name:
Orphan Designation:
Treatment of immune thrombocytopenic purpura.

Designation
3/27/2003 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
One Amgen Center Drive
Thousand Oaks CA 91320-1799

***************************************************************************************
Generic Name Approved Orphan Indication:
Amifostine

Trade Name:
Ethyol Orphan Designation:
Treatment of myelodysplastic syndromes.

Designation
10/4/1999 Sponsor and Address
Marketing Exclusivity Medimmune Oncology, Inc.
One MedImmune Way
Gaithersburg MD 20878

***************************************************************************************
Generic Name Approved Orphan Indication:
Amifostine

Trade Name:
Ethyol Orphan Designation:
For use as a chemoprotective agent for cisplatin in the treatment of
metastatic melanoma.
Designation
5/30/1990 Sponsor and Address
Marketing Exclusivity Medimmune Oncology, Inc.
One MedImmune Way
Gaithersburg MD 20878

***************************************************************************************
Generic Name Approved Orphan Indication:
Amifostine

Trade Name:
Ethyol Orphan Designation:
For use as a chemoprotective agent for cyclophosphamide in the
treatment of advanced ovarian carcinoma.
Designation
5/30/1990 Sponsor and Address
Marketing Exclusivity Medimmune Oncology, Inc.
One MedImmune Way
Gaithersburg MD 20878

***************************************************************************************
Generic Name Approved Orphan Indication:
Amifostine To reduce the cumulative renal toxicity associated with repeated
administration of cisplatin in patients with advanced ovarian cancer.

Trade Name:
Ethyol Orphan Designation:
For use as a chemoprotective agent for cisplatin in the treatment of
advanced ovarian carcinoma.
Designation
5/30/1990 Sponsor and Address
Marketing Exclusivity Medimmune Oncology, Inc.
12/8/1995 One Tower Bridge
100 Front Street, Suite 400
West Conshohocken PA 19428
***************************************************************************************
Generic Name Approved Orphan Indication:
Amifostine Reduction of the incidence of moderate to severe xerostomia in
patients undergoing post-operative radiation treatment for head and
neck cancer, where the radiation port includes a substantial portion of
Trade Name: the parotid glands.
Ethyol Orphan Designation:
Reduction of the incidence of moderate to severe xerostomia in
patients undergoing post-operative radiation treatment for head and
Designation neck cancer.
5/12/1998 Sponsor and Address
Marketing Exclusivity Medimmune Oncology, Inc.
6/24/1999 One Tower Bridge
100 Front Street, Suite 400
Conshohocken PA 19428
***************************************************************************************
Generic Name Approved Orphan Indication:
Amifostine

Trade Name:
Ethyol Orphan Designation:
For the reduction of the incidence and severity of toxicities associated
with cisplatin administration.
Designation
11/24/1998 Sponsor and Address
Marketing Exclusivity Medimmune Oncology, Inc.
One MedImmune Way
Gaithersburg MD 20878

***************************************************************************************
Generic Name Approved Orphan Indication:
Amikacin

Trade Name:
SLIT Amikacin Orphan Designation:
Treatment of bronchopulmonary Pseudomonas aeruginosa infections
in cystic fibrosis patients
Designation
3/9/2006 Sponsor and Address
Marketing Exclusivity Transave, Inc.
11 Deer Park Drive
Monmouth Junction NJ 08852-1923

***************************************************************************************
Generic Name Approved Orphan Indication:
Amiloride HCl solution for inhalation

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis.

Designation
7/18/1990 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Research and Development
5 Moore Drive
PO Box 13398
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Aminocaproic acid

Trade Name:
Caprogel Orphan Designation:
For the topical treatment of traumatic hyphema of the eye.

Designation
1/6/1995 Sponsor and Address
Marketing Exclusivity Eastern Virginia Medical School
Department of Ophthalomology
880 Kempsville Road, Suite 2500
Norfolk VA 23502-3990
***************************************************************************************
Generic Name Approved Orphan Indication:
Aminolevlinic acid hydrochloride

Trade Name:
Levulan Orphan Designation:
Treatment of esophageal dysplasia

Designation
3/20/2007 Sponsor and Address
Marketing Exclusivity DUSA Pharmaceuticals, Inc.
25 Upton Drive
Wilmington MA 01887

***************************************************************************************
Generic Name Approved Orphan Indication:
Aminosalicylate sodium

Trade Name:
Orphan Designation:
Treatment of Crohn's disease.

Designation
4/6/1993 Sponsor and Address
Marketing Exclusivity Syncom Pharmaceuticals, Inc.
66 Hanover Road
Florham Park NJ 07932

***************************************************************************************
Generic Name Approved Orphan Indication:
Aminosalicylic acid Treatment of tuberculosis

Trade Name:
Paser Granules Orphan Designation:
Treatment of tuberculosis infections

Designation
2/19/1992 Sponsor and Address
Marketing Exclusivity Jacobus Pharmaceutical Company
6/30/1994 37 Cleveland Lane
P.O. Box 5290
Princeton NJ 08540
***************************************************************************************
Generic Name Approved Orphan Indication:
Aminosidine

Trade Name:
Paromomycin Orphan Designation:
Treatment of visceral leishmaniasis

Designation
3/29/2005 Sponsor and Address
Marketing Exclusivity The Institute for One World Health
580 California Street
San Francisco CA 94104

***************************************************************************************
Generic Name Approved Orphan Indication:
Aminosidine

Trade Name:
Paromomycin Orphan Designation:
Treatment of visceral leishmaniasis (kala-azar).

Designation
9/9/1994 Sponsor and Address
Marketing Exclusivity Kanyok, Thomas P. Pharm.D.
University of Illinois at Chicago College of Pharm
833 South Wood Street (m/c886) Rm. 176
Chicago IL 60612
***************************************************************************************
Generic Name Approved Orphan Indication:
Aminosidine

Trade Name:
Gabbromicina Orphan Designation:
Treatment of tuberculosis.

Designation
5/14/1993 Sponsor and Address
Marketing Exclusivity Kanyok, Thomas P. Pharm.D.
University Of Illinois At Chicago College of Pharm
833 South Wood Street (m/c886) Rm. 176
Chicago IL 60612
***************************************************************************************
Generic Name Approved Orphan Indication:
Aminosidine

Trade Name:
Gabbromicina Orphan Designation:
Treatment of Mycobacterium avium complex.

Designation
11/15/1993 Sponsor and Address
Marketing Exclusivity Kanyok, Thomas P. Pharm.D.
University of Illinois at Chicago College of Pharm
833 South Wood Street (m/c886) Rm. 176
Chicago IL 60612
***************************************************************************************
Generic Name Approved Orphan Indication:
Amiodarone

Trade Name:
Amio-Aqueous Orphan Designation:
Treatment of incessant ventricular tachycardia.

Designation
8/17/1993 Sponsor and Address
Marketing Exclusivity Academic Pharmaceuticals, Inc.
21 N. Skokie Valley Highway
Suite G3
Lake Bluff IL 60044
***************************************************************************************
Generic Name Approved Orphan Indication:
Amiodarone HCl For initiation of treatment and prophylaxis of frequently recurring
ventricular fibrillation and hemodynamically unstable ventricular
tachycardia in patients refractory to other therapy.
Trade Name:
Cordarone Orphan Designation:
For the acute treatment and prophylaxis of life-threatening ventricular
tachycardia or ventricular fibrillation.
Designation
3/16/1994 Sponsor and Address
Marketing Exclusivity Wyeth-Ayerst Laboratories
8/3/1995 P.O. Box 8299
Philadelphia PA 19101

***************************************************************************************
Generic Name Approved Orphan Indication:
Ammonium tetrathiomolybdate

Trade Name:
Coprexa Orphan Designation:
Treatment of Wilson's disease.

Designation
1/31/1994 Sponsor and Address
Marketing Exclusivity Pipex Pharmaceuticals, Inc.
3930 Varsity Drive
Ann Arbor MI 48108

***************************************************************************************
Generic Name Approved Orphan Indication:
amonafide L-malate

Trade Name:
Xanafide Orphan Designation:
Treatment of acute myeloid leukemia.

Designation
12/20/2006 Sponsor and Address
Marketing Exclusivity Xanthus Pharmaceuticals, Inc.
300 Technology Square
Cambridge MA 02139

***************************************************************************************
Generic Name Approved Orphan Indication:
Amphotericin B inhalation powder

Trade Name:
Orphan Designation:
Prevention of pulmonary fungal infections in patients at risk for
aspergillosis due to immunosuppressive therapy including those
Designation receiving organ or stem cell transplants, or teated with chemotherapy
12/15/2005 or radiation for hematologic malignancies
Sponsor and Address
Marketing Exclusivity Nektar Therapeutics
150 Industrial Road
San Carlos CA 94070-6256

***************************************************************************************
Generic Name Approved Orphan Indication:
Amphotericin B lipid complex

Trade Name:
Abelcet Orphan Designation:
Treatment of invasive protothecosis.

Designation
8/21/1996 Sponsor and Address
Marketing Exclusivity The Liposome Company, Inc.
One Research Way
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Amphotericin B lipid complex

Trade Name:
Abelcet Orphan Designation:
Treatment of invasive sporotrichosis.

Designation
9/23/1996 Sponsor and Address
Marketing Exclusivity The Liposome Company, Inc.
One Research Way
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Amphotericin B lipid complex

Trade Name:
Abelcet Orphan Designation:
Treatment of invasive coccidioidomycosis.

Designation
5/6/1996 Sponsor and Address
Marketing Exclusivity The Liposome Company, Inc.
One Research Way
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Amphotericin B lipid complex

Trade Name:
Abelcet Orphan Designation:
Treatment of invasive zygomycosis.

Designation
5/6/1996 Sponsor and Address
Marketing Exclusivity The Liposome Company, Inc.
One Research Way
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Amphotericin B lipid complex

Trade Name:
Abelcet Orphan Designation:
Treatment of invasive candidiasis.

Designation
6/27/1996 Sponsor and Address
Marketing Exclusivity The Liposome Company, Inc.
One Research Way
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Amphotericin B lipid complex Treatment of invasive fungal infections in patients who are refractory
to or intolerant of conventional amphotericin B therapy.

Trade Name:
Abelcet Orphan Designation:
Treatment of invasive fungal infections.

Designation
12/5/1991 Sponsor and Address
Marketing Exclusivity Liposome Company, Inc.
10/18/1996 One Research Way
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Amsacrine

Trade Name:
Amsidyl Orphan Designation:
Treatment of acute adult leukemia.

Designation
12/7/1984 Sponsor and Address
Marketing Exclusivity Warner-Lambert Company
Parke-Davis Pharmaceutical Research Division
2800 Plymouth Road
Ann Arbor MI 48106
***************************************************************************************
Generic Name Approved Orphan Indication:
Amyl nitrite, sodium nitrite, sodium thiosulfate

Trade Name:
Cyanide Antidote Kit Orphan Designation:
Treatment of cyanide poisoning

Designation
12/18/2006 Sponsor and Address
Marketing Exclusivity Akorn, Inc.
2500 Millbrook Drive
Buffalo Grove IL 60089

***************************************************************************************
Generic Name Approved Orphan Indication:
Anagrelide

Trade Name:
Agrylin Orphan Designation:
Treatment of thrombocytosis in chronic myelogenous leukemia.

Designation
7/14/1986 Sponsor and Address
Marketing Exclusivity Roberts Pharmaceutical Corp.
Meridian Center II
4 Industrial Way West
Eatontown NJ 07724-2274
***************************************************************************************
Generic Name Approved Orphan Indication:
Anagrelide Treatment of patients with essential thrombocythemia to reduce the
elevated platelet count and the risk of thrombosis and to ameliorate
associated symptoms.
Trade Name:
Agrylin Orphan Designation:
Treatment of essential thrombocythemia.

Designation
1/27/1988 Sponsor and Address
Marketing Exclusivity Roberts Pharmaceutical Corp.
3/14/1997 Meridian Center III
6 Industrial Way West
Eatontown NJ 07724
***************************************************************************************
Generic Name Approved Orphan Indication:
Anagrelide

Trade Name:
Agrylin Orphan Designation:
Treatment of polycythemia vera.

Designation
6/11/1985 Sponsor and Address
Marketing Exclusivity Roberts Pharmaceutical Corp.
Meridian Center II
4 Industrial Way West
Eatontown NJ 07724-2274
***************************************************************************************
Generic Name Approved Orphan Indication:
Ananain, comosain

Trade Name:
Vianain Orphan Designation:
For the enzymatic debridement of severe burns.

Designation
1/21/1992 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
One Kendall Square
Cambridge MA 02139

***************************************************************************************
Generic Name Approved Orphan Indication:
Anaritide acetate

Trade Name:
Auriculin Orphan Designation:
Treatment of patients with acute renal failure.

Designation
8/27/1992 Sponsor and Address
Marketing Exclusivity Scios, Inc.
2450 Bayshore Parkway
Mountain View CA 94043

***************************************************************************************
Generic Name Approved Orphan Indication:
Anaritide acetate

Trade Name:
Auriculin Orphan Designation:
Improvement of early renal allograft function following renal
transplantation.
Designation
4/10/1992 Sponsor and Address
Marketing Exclusivity Scios, Inc.
2450 Bayshore Parkway
Mountain View CA 94043

***************************************************************************************
Generic Name Approved Orphan Indication:
Anatibant

Trade Name:
Orphan Designation:
Treatment of patients having experienced a severe traumatic brain
injury (Glasgow Coma Scale 3 to 8) in order to decrease early
Designation mortality and improve long-term functional and neurological
4/15/2005 Sponsor and Address outcome
Marketing Exclusivity Xytis, Inc.
400 South El Camino Real
Suite 1200
San Mateo CA 94402-1703
***************************************************************************************
Generic Name Approved Orphan Indication:
Ancrod

Trade Name:
Viprinex Orphan Designation:
To establish and maintain anticoagulation in heparin-intolerant
patients undergoing cardiopulmonary bypass.
Designation
10/20/1989 Sponsor and Address
Marketing Exclusivity Knoll Pharmaceutical Company
3000 Continental Dr., North
Mt. Olive NJ 07828

***************************************************************************************
Generic Name Approved Orphan Indication:
Angiotensin 1-7

Trade Name:
MARstem Orphan Designation:
Treatment of myelodysplastic syndrome

Designation
8/3/2001 Sponsor and Address
Marketing Exclusivity Maret Pharmaceutical Corporation
4041 MacArthur Boulevard, Suite 375
Newport Beach CA 92660

***************************************************************************************
Generic Name Approved Orphan Indication:
Angiotensin 1-7

Trade Name:
Orphan Designation:
Treatment of neutropenia associated with autologous bone marrow
transplantation.
Designation
2/16/2000 Sponsor and Address
Marketing Exclusivity Maret Pharmaceuticals
4041 MacArthur Blvd.
Suite 375
Newport Beach CA 92660
***************************************************************************************
Generic Name Approved Orphan Indication:
Anti pan T lymphocyte monoclonal antibody

Trade Name:
Anti-t Lymphocyte Immunotoxin Xmmly-h65-rta Orphan Designation:
For ex-vivo treatment to eliminate mature T cells from potential bone
marrow grafts.
Designation
1/29/1986 Sponsor and Address
Marketing Exclusivity Xoma Corporation
2910 Seventh Street
Berkeley CA 94710

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti pan T lymphocyte monoclonal antibody

Trade Name:
Anti-t Lymphocyte Immunotoxin Xmmly-h65-rta Orphan Designation:
For in-vivo treatment of bone marrow recipients to prevent graft
rejection and graft versus host disease.
Designation
1/29/1986 Sponsor and Address
Marketing Exclusivity Xoma Corporation
2910 Seventh Street
Berkeley CA 94710

***************************************************************************************
Generic Name Approved Orphan Indication:
antiangiogenic components extracted from marine
cartilage

Trade Name:
Neovastat (AE-941) Orphan Designation:
Treatment of renal cell carcinoma

Designation
10/16/2002 Sponsor and Address
Marketing Exclusivity AEterna Zentaris, Inc.
Dr. Claude Hariton
Chief Medical Officer, VP, Cli
Quebec G1P 4P5, Canada
CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
anti-CD23 IgG1, kappa monoclonal antibody

Trade Name:
Orphan Designation:
Treatment of chronic lymphocytic leukemia

Designation
2/12/2003 Sponsor and Address
Marketing Exclusivity Biogen IDEC, Inc.

5200 Research Place


San Diego CA 92122
***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-CD40 mAb

Trade Name:
Orphan Designation:
Treatment of chronic lymphocytic leukemia

Designation
10/6/2005 Sponsor and Address
Marketing Exclusivity Seattle Genetics, Inc.
21823 30th Drive Southeast
Bothell WA 98021

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-CD45 monoclonal antibodies

Trade Name:
Orphan Designation:
Prevention of acute graft rejection of human organ transplants.

Designation
9/10/1990 Sponsor and Address
Marketing Exclusivity Baxter Healthcare Corporation
1620 Waukegan Road
Mcgaw Park IL 60085

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-CEA Sheep-human chimeric monoclonal
antibody labeled w/iodine-131 (KAb201)

Trade Name:
Orphan Designation:
Treatment of pancreatic cancer

Designation
5/21/2003 Sponsor and Address
Marketing Exclusivity Xenova Biomedix Limited
957 Buckingham Avenue
Berkshire SL1 4NL

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-cytomegalovirus monoclonal antibodies

Trade Name:
Orphan Designation:
Prevention of human cytomegalovirus infection in bone marrow and
organ transplant patients.
Designation
5/2/1990 Sponsor and Address
Marketing Exclusivity Biomedical Research Institute
345 North Smith Avenue
St. Paul MN 55102

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-cytomegalovirus monoclonal antibodies

Trade Name:
Orphan Designation:
Treatment of human cytomegalovirus infection in bone marrow and
organ transplant patients.
Designation
5/2/1990 Sponsor and Address
Marketing Exclusivity Biomedical Research Institute
345 North Smith Avenue
St. Paul MN 55102

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-cytomegalovirus monoclonal antibodies

Trade Name:
Orphan Designation:
Prevention of human cytomegalovirus infection in patients diagnosed
with AIDS.
Designation
5/3/1990 Sponsor and Address
Marketing Exclusivity Biomedical Research Institute
345 North Smith Avenue
St. Paul MN 55102

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-cytomegalovirus monoclonal antibodies

Trade Name:
Orphan Designation:
Treatment of human cytomegalovirus infection in patients diagnosed
with AIDS.
Designation
5/3/1990 Sponsor and Address
Marketing Exclusivity Biomedical Research Institute
345 North Smith Avenue
St. Paul MN 55102

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-cytotoxic T lymphocyte antigen 4 monoclonal
antibody

Trade Name:
Orphan Designation:
Treatment of stage IIb to stage IV metastatic melanoma

Designation
9/18/2006 Sponsor and Address
Marketing Exclusivity Pfizer Global Research & Development
50 Pequot Avenue
New London CT 06320

***************************************************************************************
Generic Name Approved Orphan Indication:
Antiepilepsirine

Trade Name:
Orphan Designation:
Treatment of drug resistant generalized tonic-clonic epilepsy in
children and adults.
Designation
3/23/1989 Sponsor and Address
Marketing Exclusivity Children's Hospital
700 Children's Drive
Columbus OH 43205

***************************************************************************************
Generic Name Approved Orphan Indication:
Antihemophilic factor (human) For surgical and/or invasive procedures in patients with von
Willebrand Disease (VWD) in whom desmopressin is either ineffective
or contraindicated. It is not indicated for patients with severe VWD
Trade Name: (Type 3) undergoing major surgery
Alphanate Orphan Designation:
Treatment of von Willebrand's disease

Designation
1/5/1996 Sponsor and Address
Marketing Exclusivity Grifols Biologicals Inc.
1/31/2007 5555 Valley Boulevard
Los Angeles CA 90032-3548

***************************************************************************************
Generic Name Approved Orphan Indication:
Antihemophilic factor (recombinant)

Trade Name:
ReFacto Orphan Designation:
For the control and prevention of hemorrhagic episodes and for
surgical prophylaxis in patients with hemophilia A (congenital factor
Designation VIII deficiency or classic hemophilia).
2/8/1996 Sponsor and Address
Marketing Exclusivity Wyeth Pharmaceuticals, Inc.
P. O. Box 8299
Philadelphia PA 19101-8299

***************************************************************************************
Generic Name Approved Orphan Indication:
Antihemophilic factor (recombinant) Treatment and prophylaxis of bleeding in patients with hemophilia A
(not von Willebrand's disease)

Trade Name:
Kogenate Orphan Designation:
Prophylaxis and treatment of bleeding in individuals with hemophilia
A or for prophylaxis when surgery is required in individuals with
Designation hemophilia A.
9/25/1989 Sponsor and Address
Marketing Exclusivity Bayer Corporation
2/25/1993 1884 Miles Avenue
Elkhart IN 46515

***************************************************************************************
Generic Name Approved Orphan Indication:
Antihemophilic factor/von Willebrand factor complex (1) In adult patients for treatment and prevention of bleeding in
(human), dried, pasteurized hemophilia A (classic hemophilia) and (2) in adult and pediatric
patients for treatment of spontaneous and trauma-induced bleeding
episodes in severe von Willebrand disease, and in mild and
Trade Name: moderate von Willebrand disease where use of desmopressin is
Humate-P Orphan Designation:
Treatment of patients with von Willebrand's disease

Designation
10/16/1992 Sponsor and Address
Marketing Exclusivity Aventis Behring L.L.C.
4/1/1999 1020 First Avenue
PO Box 61501
King Of Prussia PA 19406-0901
***************************************************************************************
Generic Name Approved Orphan Indication:
anti-interferon-gamma Fab from goats

Trade Name:
Orphan Designation:
For the treatment of immunologic corneal allograft rejection

Designation
11/18/2003 Sponsor and Address
Marketing Exclusivity Advanced Biotherapy, Inc.
6355 Topanga Canyon Blvd.
Suite 510
Woodland Hills CA 91367
***************************************************************************************
Generic Name Approved Orphan Indication:
Antimelanoma Antibody XMMME-001-DTPA 111
Indium
Trade Name:
Antimelanoma Antibody XMMME-001-DTPA 111 Orphan Designation:
Indium Diagnostic use in imaging systemic and nodal melanoma metastasis.

Designation
11/14/1984 Sponsor and Address
Marketing Exclusivity Xoma Corporation
2910 Seventh Street
Berkeley CA 94710

***************************************************************************************
Generic Name Approved Orphan Indication:
Antimelanoma Antibody XMMME-001-RTA

Trade Name:
Antimelanoma Antibody XMMME-001-RTA Orphan Designation:
Treatment of stage III melanoma not amenable to surgical resection.

Designation
11/14/1984 Sponsor and Address
Marketing Exclusivity Xoma Corporation
2910 Seventh Street
Berkeley CA 94710

***************************************************************************************
Generic Name Approved Orphan Indication:
Antipyrine Test

Trade Name:
Orphan Designation:
For use as an index of hepatic drug-metabolizing capacity.

Designation
2/21/1985 Sponsor and Address
Marketing Exclusivity Upsher-Smith Laboratories, Inc
4905 23rd Avenue North
Minneapolis MN 55447

***************************************************************************************
Generic Name Approved Orphan Indication:
Antisense 20-mer oligonucleotide complementary to
R2 component of ribonucleotide reductase mRNA

Trade Name:
Orphan Designation:
Treatment of acute myeloid leukemia

Designation
4/15/2005 Sponsor and Address
Marketing Exclusivity Lorus Therapeutics, Inc.
2 Meridan Road
M9W 4Z7

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
antisense 20-mer phosphorothioate oligonucleotide
[complementary to the coding region of R2
component of the human ribonucleotide reductase

Trade Name:
GTI-2040 Orphan Designation:
Treatment for renal cell carcinoma

Designation
3/12/2003 Sponsor and Address
Marketing Exclusivity Lorus Therapeutics, Inc
2 Meridan Road
M9W427

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Antisense inhibitor of apoB-100

Trade Name:
Orphan Designation:
Treatment of homozygous familial hypercholesterolemia

Designation
5/23/2006 Sponsor and Address
Marketing Exclusivity Isis Pharmaceuticals, Inc.
1896 Rutherford ?Road
Carlbad CA 92008

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-tap-72 immunotoxin

Trade Name:
Xomazyme-791 Orphan Designation:
Treatment of metastatic colorectal adenocarcinoma.

Designation
3/6/1987 Sponsor and Address
Marketing Exclusivity Xoma Corporation
2910 Seventh Street
Berkeley CA 94710

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-tenascin 81C6 monoclonal antibody labeled w/ I
131
Trade Name:
Orphan Designation:
Treatment of primary malignant brain tumors

Designation
10/4/2005 Sponsor and Address
Marketing Exclusivity Bradmer Pharmaceuticals, Inc.
9900 Corporate Campus Drive
Suite 3000
Louisville KY 40223
***************************************************************************************
Generic Name Approved Orphan Indication:
Antithrombin III (human)

Trade Name:
ATnativ Orphan Designation:
For the treatment of patients with hereditary antithrombin III
deficiency in connection with surgical or obstetrical procedures or
Designation when they suffer from thromboembolism.
2/8/1985 Sponsor and Address
Marketing Exclusivity Pharmacia & Upjohn AB
12/13/1989 Lindhagensgatan 133
SE-112 87

SWEDEN
***************************************************************************************
Generic Name Approved Orphan Indication:
Antithrombin III (human)

Trade Name:
Thrombate III Orphan Designation:
For replacement therapy in congenital deficiency of AT-III for
prevention and treatment of thrombosis and pulmonary emboli.
Designation
11/26/1984 Sponsor and Address
Marketing Exclusivity Bayer Corporation
12/30/1991 Pharmaceutical Division, Biological Products
400 Morgan Lane
New Haven CT 06516
***************************************************************************************
Generic Name Approved Orphan Indication:
Antithrombin III (human) concentrate IV

Trade Name:
Kybernin P Orphan Designation:
For prophylaxis and treatment of thromboembolic episodes in
patients with genetic AT-III deficiency.
Designation
7/2/1985 Sponsor and Address
Marketing Exclusivity CSL Behring
1020 First Ave.
PO Box 61501
King of Prussia PA 19406-0901
***************************************************************************************
Generic Name Approved Orphan Indication:
Antithrombin III human

Trade Name:
Antithrombin III human Orphan Designation:
Preventing or arresting episodes of thrombosis in patients with
congenital AT-III deficiency and/or to prevent the occurrence of
Designation thrombosis in patients with AT-III deficiency who have undergone
1/2/1986 trauma or who are about to undergo surgery or parturition.
Sponsor and Address
Marketing Exclusivity American National Red Cross
9312 Old Georgetown Road
Bethesda MD 20814

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-thymocyte Globulin (Rabbitt)

Trade Name:
Thymoglobulin Orphan Designation:
Treatment of myelodysplastic syndrome (MDS)

Designation
9/6/2000 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
500 Kendall Street
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Anti-thymocyte serum

Trade Name:
Nashville Rabbit Anti-thymocyte Serum Orphan Designation:
Treatment of allograft rejection, including solid organ (kidney, liver,
heart, lung, and pancreas) and bone marrow transplantation.
Designation
6/2/1993 Sponsor and Address
Marketing Exclusivity Applied Medical Research
1600 Hayes Street
Nashville TN 37203

***************************************************************************************
Generic Name Approved Orphan Indication:
Antivenin crotaline (pit-viper) equine immune F(ab)2)

Trade Name:
Antivipmyn Orphan Designation:
Treatment of envenomation by Crotaline snakes

Designation
1/29/2004 Sponsor and Address
Marketing Exclusivity Rare Disease Therapeutics, Inc.
1101 Kermit Drive,
Suite 608
Nashville TN 37217
***************************************************************************************
Generic Name Approved Orphan Indication:
Antivenin, crotalidae polyvalent immune Fab (ovine) Carol Clark-Evans direct line (615) 963-4510

Trade Name:
CroFab Orphan Designation:
Treatment of envenomations inflicted by North American crotalid
snakes.
Designation
1/12/1994 Sponsor and Address
Marketing Exclusivity Protherics, Inc.
10/2/2000 1207 17th Ave. S., Suite 103
Nashville TN 37212

***************************************************************************************
Generic Name Approved Orphan Indication:
Antivenom (crotalidae) purified (avian)

Trade Name:
Orphan Designation:
Treatment of envenomation by poisonous snakes belonging to the
Crotalidae family.
Designation
2/12/1991 Sponsor and Address
Marketing Exclusivity Ophidian Pharmaceuticals, Inc.
5445 East Cheryl Parkway
Madison WI 53711

***************************************************************************************
Generic Name Approved Orphan Indication:
AP1903

Trade Name:
Orphan Designation:
Treatment of acute graft-versus-host disease in patients undergoing
bone marrow transplantation.
Designation
11/24/1999 Sponsor and Address
Marketing Exclusivity Ariad Pharmaceuticals, Inc.
26 Landsdowne St.
Cambridge MA 02139-4234

***************************************************************************************
Generic Name Approved Orphan Indication:
APL 400-020 V-Beta DNA vaccine

Trade Name:
Orphan Designation:
Treatment of cutaneous T cell lymphoma.

Designation
3/8/1995 Sponsor and Address
Marketing Exclusivity Wyeth-Lederle Vaccines and Pediatrics
211 Bailey Rd.
West Henrietta NY 14586-9728

***************************************************************************************
Generic Name Approved Orphan Indication:
Apomorphine

Trade Name:
Orphan Designation:
For use as rescue treatment for early morning motor dysfunction in
late-stage Parkinson's disease.
Designation
10/20/1997 Sponsor and Address
Marketing Exclusivity Scherer DDS
Frankland Road
Swindon SN5 8RU
Wiltshire
UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Apomorphine

Trade Name:
Orphan Designation:
Treatment of the on-off fluctuations associated with late-stage
Parkinson's disease.
Designation
7/17/1995 Sponsor and Address
Marketing Exclusivity Pentech Pharmaceuticals, Inc.
1110 Lake Cook Rd.
Suite 257
Buffalo Grove IL 60089
***************************************************************************************
Generic Name Approved Orphan Indication:
Apomorphine HCl For the acute, intermittent treatment of hypomobility, "off" episodes
("end-of-dose-wearing-off" and unpredictable :on/off" episodes)
associated with advanced Parkinson's disease
Trade Name:
Apokyn Orphan Designation:
Treatment of the on-off fluctuations associated with late-stage
Parkinson's disease.
Designation
4/22/1993 Sponsor and Address
Marketing Exclusivity Vernalis R & D Ltd
4/20/2004 Oakdene Court
Winnersh, Berkshire RG41 5UA

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Apomorphine hydrochloride

Trade Name:
Orphan Designation:
For the treatment of patients in a vegetative state or minimally
conscious state for up to 12 months following a severe traumatic brain
Designation injury (traumatic or spontaneous)
5/23/2006 Sponsor and Address
Marketing Exclusivity NeuroHealing Pharmaceuticals, Inc.
50 Undine Road
Newton MA 02135

***************************************************************************************
Generic Name Approved Orphan Indication:
Aprotinin

Trade Name:
Trasylol Orphan Designation:
For prophylactic use to reduce perioperative blood loss and the
homologous blood transfusion requirement in patients undergoing
Designation cardiopulmonary bypass surgery in the course of repeat coronary
11/17/1993 artery bypass graft surgery, and in selected cases of primary coronary
artery bypass graft surgery where the risk of bleeding is especially
high (impaired hemostasis) or where transfusion is unavailable or
Sponsor and Address
Marketing Exclusivity Bayer Corporation
12/29/1993 Pharmaceutical Division
400 Morgan Lane
West Haven CT 06516
***************************************************************************************
Generic Name Approved Orphan Indication:
Arcitumomab

Trade Name:
99m Tc-labeled CEA-Scan Orphan Designation:
Diagnosis and localization of primary, residual, recurrent and
metastatic medullary thyroid carcinoma.
Designation
5/10/1996 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Arginine butyrate

Trade Name:
Orphan Designation:
Treatment of sickle cell disease and beta thalassemia.

Designation
5/25/1994 Sponsor and Address
Marketing Exclusivity Vertex Pharmaceuticals Inc.
130 Waverly Street
Cambridge MA 02139-4242

***************************************************************************************
Generic Name Approved Orphan Indication:
Arginine butyrate

Trade Name:
Orphan Designation:
Treatment of beta-hemoglobinopathies and beta-thalassemia.

Designation
4/7/1992 Sponsor and Address
Marketing Exclusivity Perrine, Susan P., M.D.
Boston University
Cancer Research Center
Boston MA 02118
***************************************************************************************
Generic Name Approved Orphan Indication:
arimoclomol

Trade Name:
Orphan Designation:
Treatment of amyotrophic lateral sclerosis

Designation
3/29/2005 Sponsor and Address
Marketing Exclusivity CytRx Corporation
11726 San Vicente Blvd.
Los Angeles CA 90049

***************************************************************************************
Generic Name Approved Orphan Indication:
Aripiprazole

Trade Name:
Abilify Orphan Designation:
Treatment of Tourette's syndrome

Designation
1/25/2006 Sponsor and Address
Marketing Exclusivity Floyd R. Sallee, M.D., Ph.D.
University of Cincinnati School of Medicine/
P. O. Box 670669 231 Albert Sabin Way
Cincinnati OH 45267-0559
***************************************************************************************
Generic Name Approved Orphan Indication:
arsenic

Trade Name:
Trisenox Orphan Designation:
Treatment of acute myelocytic leukemia subtypes M0, M1, M2, M4,
M5, M6 and M7
Designation
11/2/2001 Sponsor and Address
Marketing Exclusivity Cephalon, Inc.
41 Moores Road
Frazer PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Arsenic trioxide

Trade Name:
Trisenox Orphan Designation:
Treatment of malignant glioma

Designation
3/4/2005 Sponsor and Address
Marketing Exclusivity Cephalon Inc
41 Moores Road
Frazer PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
arsenic trioxide

Trade Name:
Trisenox Orphan Designation:
Treatment of chronic myeloid leukemia

Designation
10/18/2001 Sponsor and Address
Marketing Exclusivity Cephalon, Inc.
41 Moores Road
Frazer PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Arsenic trioxide For induction of remission and consolidation in patients with acute
promyelocytic leukemia (APL) who are refractory to, or have relapsed
from, retinoid and anthracycline chemotherapy, and whose APL is
Trade Name: characterized by the presence of the t(15;17) translocation of
PML/RAR-alpha gene expression.
Trisenox Orphan Designation:
Treatment of acute promyelocytic leukemia.

Designation
3/3/1998 Sponsor and Address
Marketing Exclusivity Cell Therapeutics, Inc.
9/25/2000 201 Elliott Ave. West
Suite 400
Seattle WA 98119
***************************************************************************************
Generic Name Approved Orphan Indication:
Arsenic trioxide

Trade Name:
Trisenox Orphan Designation:
Treatment of multiple myeloma.

Designation
4/28/2000 Sponsor and Address
Marketing Exclusivity Cephalon, Inc.
41 Moores Road
Frazer PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
arsenic trioxide

Trade Name:
Trisenox Orphan Designation:
Treatment of liver cancer

Designation
6/13/2003 Sponsor and Address
Marketing Exclusivity Cephalon, Inc.
41 Moores Road
Frazer PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Arsenic trioxide

Trade Name:
Trisenox Orphan Designation:
Treatment of chronic lymphocytic leukemia

Designation
5/13/2003 Sponsor and Address
Marketing Exclusivity Cephalon, Inc.
41 Moores Road
Frazer PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
arsenic trioxide

Trade Name:
Trisenox Orphan Designation:
Treatment of myelodysplastic syndrome.

Designation
7/17/2000 Sponsor and Address
Marketing Exclusivity Cephalon, Inc.
41 Moores Road
P.O. Box 4011
Frazer PA 19355
***************************************************************************************
Generic Name Approved Orphan Indication:
artemether/lumefantrine

Trade Name:
Coartem Orphan Designation:
For the treatment of infections due to Plasmodium falciparum or
mixed infections including P. falciparum.
Designation
8/31/2007 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals
Bldg 405/4051
One Health Plaza
East Hanover NJ 07936-1080
***************************************************************************************
Generic Name Approved Orphan Indication:
Artesunate

Trade Name:
Orphan Designation:
Immediate treatment of malaria

Designation
3/28/2006 Sponsor and Address
Marketing Exclusivity US Army Medical Materiel Development Activity
Office of the Surgeon General
622 Neiman Street
Ft. Detrick MD 21702-9240
***************************************************************************************
Generic Name Approved Orphan Indication:
Artesunate

Trade Name:
Orphan Designation:
Treatment of malaria.

Designation
7/19/1999 Sponsor and Address
Marketing Exclusivity World Health Organization
Special Programme for Research and Training in Tro
Via Appia , Geneva 27

***************************************************************************************
Generic Name Approved Orphan Indication:
As-101

Trade Name:
Orphan Designation:
Treatment of acquired immunodeficiency syndrome.

Designation
11/9/1987 Sponsor and Address
Marketing Exclusivity NPDC-AS101, Inc.
783 Jersey Avenue
New Brunswick NJ 08901

***************************************************************************************
Generic Name Approved Orphan Indication:
Ascorbic acid

Trade Name:
Ascor L 500 Orphan Designation:
Treatment of scurvy

Designation
8/31/2007 Sponsor and Address
Marketing Exclusivity McGuff Pharmaceuticals Inc.
2921 W. McArthur Blvd.
Santa Ana CA 92704-6929

***************************************************************************************
Generic Name Approved Orphan Indication:
Atomoxetine hydrochloride

Trade Name:
STRATTERA Orphan Designation:
Treatment of Tourette's Syndrome

Designation
8/26/2003 Sponsor and Address
Marketing Exclusivity ELI LILLY & Company
Lilly Corporate Center
Indianapolis IN 46285

***************************************************************************************
Generic Name Approved Orphan Indication:
Atovaquone Prevention of PCP in patients who are intolerant to trimethoprim-
sulfamethoxazole.

Trade Name:
Mepron Orphan Designation:
Prevention of Pneumocystis carinii pneumonia (PCP) in high-risk,
HIV-infected patients defined by a history of one or more episodes of
Designation PCP and/or a peripheral CD4+ (T4 helper/inducer) lymphocyte count
8/14/1991 less than or equal to 200/mm3.
Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Research and Development
1/5/1999 5 Moore Drive
PO Box 13398
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Atovaquone For the acute oral treatment of mild to moderate Pneumocystis carinii
pneumonia in patients who are intolerant to trimethoprim-
sulfamethoxazole.
Trade Name:
Mepron Orphan Designation:
Treatment of AIDS associated Pneumocystis Carinii Pneumonia.

Designation
9/10/1990 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Inc.
11/25/1992 5 Moore Drive
Research Triangle Park NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Atovaquone

Trade Name:
Mepron Orphan Designation:
Primary prophylaxis of HIV-infected persons at high risk for
developing Toxoplasma gondii encephalitis.
Designation
3/16/1993 Sponsor and Address
Marketing Exclusivity GlaxoSmithKline, Inc.
5 Moore Drive
PO Box 13398
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Atovaquone

Trade Name:
Mepron Orphan Designation:
Treatment and suppression of Toxoplasma gondii encephalitis.

Designation
3/16/1993 Sponsor and Address
Marketing Exclusivity GlaxoSmithKline, Inc.
5 Moore Drive
PO Box 13398
Research Triangle Park NC 27709-3398
***************************************************************************************
Generic Name Approved Orphan Indication:
Attenuated autologous cancer cells and granulocyte
macrophage colony stimulating factor in
combination with activated autologous blood derived

Trade Name:
Orphan Designation:
Treatment of primary central nervous system malignancies

Designation
4/27/2007 Sponsor and Address
Marketing Exclusivity TVAX Biomedical, LLC
8060 Reeder Street
Lenexa KS 66214-1554

***************************************************************************************
Generic Name Approved Orphan Indication:
augmerosen

Trade Name:
Genasense Orphan Designation:
Treatment of acute myelocytic leukemia

Designation
8/28/2001 Sponsor and Address
Marketing Exclusivity Genta Inc.
Two Connell Drive
Berkeley Heights NJ 07922

***************************************************************************************
Generic Name Approved Orphan Indication:
augmerosen

Trade Name:
Genasense Orphan Designation:
Treatment of multiple myeloma

Designation
8/28/2001 Sponsor and Address
Marketing Exclusivity Genta, Inc.
Two Connell Drive
Berkeley Heights NJ 07922

***************************************************************************************
Generic Name Approved Orphan Indication:
augmerosen

Trade Name:
Genasense Orphan Designation:
Treatment of chronic lymphocytic leukemia

Designation
8/28/2001 Sponsor and Address
Marketing Exclusivity Genta, Inc,
Two Connell Drive
Berkeley Heights NJ 07922

***************************************************************************************
Generic Name Approved Orphan Indication:
autologous antigen presenting cells pulsed with
autologous tumor Ig idiotype

Trade Name:
Mylovenge Orphan Designation:
Treatment of multiple myeloma

Designation
4/18/2002 Sponsor and Address
Marketing Exclusivity Dendreon Corporation
3005 First Avenue
Seattle WA 98121

***************************************************************************************
Generic Name Approved Orphan Indication:
Autologous cultured endothelial cells on a donor
human corneal disk

Trade Name:
Orphan Designation:
Treatment of Fuch's dystrophy, pseudophakic bullous keratopathy,
and bullous keratopathy
Designation
6/1/2007 Sponsor and Address
Marketing Exclusivity Cellular Bioengineering, Inc.
1946 Young Street
Honolulu HI 96826

***************************************************************************************
Generic Name Approved Orphan Indication:
Autologous dendritic cells pulsed with autologous
antigens from primay malignant brain tumor cells

Trade Name:
DCVax-Brain Orphan Designation:
Treatment of primary brain malignant cancer

Designation
11/29/2002 Sponsor and Address
Marketing Exclusivity Northwest Biotherapeutics, Inc.
22322 20th Avenue SE
Suite 150
Bothell WA 98021
***************************************************************************************
Generic Name Approved Orphan Indication:
Autologous DNP-conjugated tumor vaccine

Trade Name:
M-Vax Orphan Designation:
For adjuvant therapy in melanoma patients with surgically resectable
lymph node metastasis (Stage III and limited Stage IV disease).
Designation
2/23/1999 Sponsor and Address
Marketing Exclusivity Avax Technologies, Inc.
9200 Indian Creek Parkway
Building 9, Suite 200
Overland Park KS 66210
***************************************************************************************
Generic Name Approved Orphan Indication:
Autologous incubated macrophage

Trade Name:
Orphan Designation:
Therapy to improve the motor and sensory neurological outcome in
acute cases of spinal cord injury
Designation
9/3/2004 Sponsor and Address
Marketing Exclusivity Proneuron Biotechnologies, Inc.
2029 Century Park East
Sixth Floor
Los Angeles CA 90067
***************************************************************************************
Generic Name Approved Orphan Indication:
Autologous or allogeneic limbal epithelial stem cells
expanded ex vivo on human amniotic membrane

Trade Name:
Orphan Designation:
Treatment of ocular surface diseases that are characterized by total
limbal stem cell deficiency
Designation
7/14/2005 Sponsor and Address
Marketing Exclusivity TissueTech, Inc.
7000 SW 97th Avenue
Miami FL 33173

***************************************************************************************
Generic Name Approved Orphan Indication:
autologous tumor-derived gp96 heat shock protein-
peptide complex

Trade Name:
Oncophage Orphan Designation:
Treatment of renal cell carcinoma

Designation
5/10/2002 Sponsor and Address
Marketing Exclusivity Antigenics, Inc.
3 Forbes Rd.
Lexington MA 02421

***************************************************************************************
Generic Name Approved Orphan Indication:
autologous tumor-derived gp96 heat shock protein-
peptide complex

Trade Name:
Oncophage Orphan Designation:
Treatment of metastatic melanoma

Designation
7/11/2002 Sponsor and Address
Marketing Exclusivity Antigenics, Inc.
3 Forbes Rd.
l MA 02421

***************************************************************************************
Generic Name Approved Orphan Indication:
Autolymphocyte therapy

Trade Name:
Orphan Designation:
Treatment of renal cell carcinoma.

Designation
7/12/1994 Sponsor and Address
Marketing Exclusivity Cytogen Corporation
600 College Road East
CN 5308
Princeton NJ 08540-5308
***************************************************************************************
Generic Name Approved Orphan Indication:
axitinib

Trade Name:
Orphan Designation:
For treatment of pancreatic cancer.

Designation
5/31/2007 Sponsor and Address
Marketing Exclusivity Pfizer, Inc.
La Jolla Laboratories
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
azacitidine Treatment of patients with the following myelodysplastic syndrome
subtypes: refractory anemia or refractory anemia with ringed
sideroblasts (if accompanied by neutropenia or thrombocytopenia
Trade Name: and requiring transfusions), refractory anemia with excess blasts,
refractory anemia with excess blasts in transformation, and chronic
Vidaza Orphan Designation:
Treatament of myelodysplastic syndromes

Designation
12/3/2001 Sponsor and Address
Marketing Exclusivity Pharmion Corporation
5/19/2004 2525 28th Street
Boulder CO 80301

***************************************************************************************
Generic Name Approved Orphan Indication:
Azathioprine

Trade Name:
Imuran Orphan Designation:
Treatment of oral manifestations of graft-versus-host disease.

Designation
9/14/1999 Sponsor and Address
Marketing Exclusivity Oral Solutions, Inc.
787 Seventh Ave., 48th Floor
New York NY 10019

***************************************************************************************
Generic Name Approved Orphan Indication:
aztreonam

Trade Name:
Orphan Designation:
Inhalation therapy for control of gram-negative bacteria in the
respiratory tract of patients with cystic fibrosis
Designation
3/12/2002 Sponsor and Address
Marketing Exclusivity Gilead Sciences (formerly Corus Pharma)
2025 First Ave.
Suite 800
Seattle WA 98121
***************************************************************************************
Generic Name Approved Orphan Indication:
Bacillus Calmette-Guerin vaccine

Trade Name:
Orphan Designation:
Treatment of stage IIb through IV metastatic melanoma

Designation
8/9/2006 Sponsor and Address
Marketing Exclusivity OncoVac Corporation
P. O. Box 970
Pacific Palisades CA 90272

***************************************************************************************
Generic Name Approved Orphan Indication:
Bacitracin

Trade Name:
Altracin Orphan Designation:
Treatment of antibiotic-associated pseudomembranous enterocolitis
caused by toxins A and B elaborated by Clostridium difficile.
Designation
3/13/1984 Sponsor and Address
Marketing Exclusivity A. L. Laboratories, Inc.
One Executive Drive
P.O. Box 1399
Fort Lee NJ 07024
***************************************************************************************
Generic Name Approved Orphan Indication:
Baclofen Management of severe spasticity of spinal cord origin in patients who
are unresponsive to oral baclofen therapy or experience intolerable
CNS side effects at effective doses.
Trade Name:
Lioresal Intrathecal Orphan Designation:
Treatment of intractable spasticity caused by spinal cord injury,
multiple sclerosis, and other spinal diseases (including spinal
Designation ischemia, spinal tumor, transverse myelitis, cervical spondylosis, and
11/10/1987 degenerative myelopathy).
Sponsor and Address
Marketing Exclusivity Medtronic, Inc.
6/25/1992 800 53rd Avenue N.E.
Minneapolis MN 55432

***************************************************************************************
Generic Name Approved Orphan Indication:
Baclofen

Trade Name:
Orphan Designation:
Treatment of intractable spasticity due to multiple sclerosis or spinal
cord injury.
Designation
12/16/1991 Sponsor and Address
Marketing Exclusivity Infusaid, Inc.
1400 Providence Highway
Norwood MA 02062

***************************************************************************************
Generic Name Approved Orphan Indication:
Baclofen

Trade Name:
Lioresal Intrathecal Orphan Designation:
Treatment of spasticity associated with cerebral palsy.

Designation
9/26/1994 Sponsor and Address
Marketing Exclusivity Medtronic, Inc.
800 53rd Avenue N.E.
P.O. 1250
Minneapolis MN 55440-9087
***************************************************************************************
Generic Name Approved Orphan Indication:
baclofen

Trade Name:
Orphan Designation:
Treatment of dystonia

Designation
12/2/2003 Sponsor and Address
Marketing Exclusivity Medtronic Neurological
710 Medtronic Parkway NE
Minneapolis MN 55432-5604

***************************************************************************************
Generic Name Approved Orphan Indication:
Balsalazide disodium Treatment of mildly to moderately active ulcerative colitis in patients
5 years of age and older. Safety and Effectiveness of Colazal
beyond 8 weeks in children (ages 5-17) and 12 weeks in adults have
Trade Name: not been established.
Colazal Orphan Designation:
Treatment of pediatric patients with ulcerative colitis

Designation
8/12/2005 Sponsor and Address
Marketing Exclusivity Salix Pharmaceuticals, Inc.
12/20/2006 1700 Perimeter Park Drive
Morrisville NC 27560

***************************************************************************************
Generic Name Approved Orphan Indication:
Basiliximab Prophylaxis of acute organ rejection in patients receiving renal
transplantation when used as part of an immunosuppressive regimen
that includes cyclosporine and corticosteroids.
Trade Name:
Simulect Orphan Designation:
Prophylaxis of solid organ rejection.

Designation
12/12/1997 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
5/12/1998 59 Route 10
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
beclomethasone 17,21-dipropionate

Trade Name:
Bec Orphan Designation:
Prevention of gastrointestinal graft-versus-host disease

Designation
8/28/2001 Sponsor and Address
Marketing Exclusivity Enteron Pharmaceuticals, Inc./DOR BioPharma, Inc.
A Subsidiary of DOR BioPharma, Inc.
850 Bear Tavern Road
Ewing NJ 08628
***************************************************************************************
Generic Name Approved Orphan Indication:
Beclomethasone dipropionate

Trade Name:
Orphan Designation:
For oral administration in the treatment of intestinal graft-versus-host
disease.
Designation
3/27/1998 Sponsor and Address
Marketing Exclusivity Enteron Pharmaceuticals, Inc./DOR BioPharma, Inc.
A Subsidiary of DOR BioPharma, Inc.
850 Bear Tavern Road
Ewing NJ 08628
***************************************************************************************
Generic Name Approved Orphan Indication:
Bendamustine hydrochloride

Trade Name:
Treanda Orphan Designation:
Treatment of chronic lymphocytic leukemia

Designation
8/17/2007 Sponsor and Address
Marketing Exclusivity Cephalon, Inc.
41 Moores Road
Frazer PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Benzoate and phenylacetate

Trade Name:
Ucephan Orphan Designation:
For adjunctive therapy in the prevention and treatment of
hyperammonemia in patients with urea cycle enzymopathy due to
Designation carbamylphosphate synthetase, ornithine, transcarbamylase, or
1/21/1986 argininosuccinate synthetase deficiency.
Sponsor and Address
Marketing Exclusivity Immunex
12/23/1987 2525 McGaw Avenue
12/23/1987 Immunex

P.O. Box 19791


Irvine CA 92623
***************************************************************************************
Generic Name Approved Orphan Indication:
benzoate/phenylacetate Adjunctive therapy in the treatment of acute hyperammonemia and
associated encephalopathy in patients with deficiencies in enzymes
of the urea cycle.
Trade Name:
Ammonul Orphan Designation:
Treatment of acute hyperammonemia and associated
encephalopathy in patients with deficiencies in enzymes of the urea
Designation cycle.
11/22/1993 Sponsor and Address
Marketing Exclusivity Medicis Pharmaceutical Corp.
2/17/2005 8125 N. Hayden Road
Scottsdale AZ 85258

***************************************************************************************
Generic Name Approved Orphan Indication:
Benzophenone-3, octylmethoxycinnamate,
avobenzone, titanium dioxide, zinc oxide

Trade Name:
Total Block VL SPF 75 Orphan Designation:
For the prevention of visible light induced skin photosensitivity as a
result of porfimer sodium photodynamic therapy
Designation
8/13/2001 Sponsor and Address
Marketing Exclusivity Fallien Cosmeceuticals Ltd.
677 W. Dekalb Pike
King of Prussia PA 19406

***************************************************************************************
Generic Name Approved Orphan Indication:
Benzydamine hydrochloride

Trade Name:
Tantum Orphan Designation:
Prophylactic treatment of oral mucositis resulting from radiation
therapy for head and neck cancer.
Designation
5/18/1998 Sponsor and Address
Marketing Exclusivity Angelini Pharmaceuticals, Inc.
70 Grand Avenue
River Edge NJ 07661

***************************************************************************************
Generic Name Approved Orphan Indication:
Benzylpenicillin, benzylpenicilloic, benzylpenilloic
acid
Trade Name:
Pre-Pen/MDM Orphan Designation:
Assessing the risk of administrating penicillin when it is the preferred
drug of choice in adult patients who have previously received
Designation penicillin and have a history of clinical sensitivity.
9/29/1987 Sponsor and Address
Marketing Exclusivity AllerQuest LLC
836 Farmington Avenue
Suite 207
West Hanford CT 06119-1551
***************************************************************************************
Generic Name Approved Orphan Indication:
Beractant

Trade Name:
Survanta Intratracheal Suspension Orphan Designation:
Treatment of full-term newborn infants with respiratory failure caused
by meconium aspiration syndrome, persistent pulmonary
Designation hypertension of the newborn, or pneumonia and sepsis.
12/20/1993 Sponsor and Address
Marketing Exclusivity Ross Laboratories
625 Cleveland Avenue
Columbus OH 43215

***************************************************************************************
Generic Name Approved Orphan Indication:
Beractant Prevention of RDS (hyaline membrane disease) in premature infants
less than 1250 grams birthweight or with evidence of surfactant
deficiency.
Trade Name:
Survanta intratracheal suspension Orphan Designation:
Prevention of neonatal respiratory distress syndrome.

Designation
2/5/1986 Sponsor and Address
Marketing Exclusivity Ross Laboratories
7/1/1991 625 Cleveland Avenue
Columbus OH 43215

***************************************************************************************
Generic Name Approved Orphan Indication:
Beractant Treatment of ("rescue") of premature infants with RDS confirmed by x-
ray and requiring mechanical ventilation.

Trade Name:
Survanta intratracheal suspension Orphan Designation:
Treatment of neonatal respiratory distress syndrome.

Designation
2/5/1986 Sponsor and Address
Marketing Exclusivity Ross Laboratories
7/1/1991 625 Cleveland Avenue
Columbus OH 43215

***************************************************************************************
Generic Name Approved Orphan Indication:
Beraprost

Trade Name:
Orphan Designation:
Treatment of pulmonary arterial hypertension associated with any
New York Heart Association classification (Class I, II, III, or IV).
Designation
4/29/1999 Sponsor and Address
Marketing Exclusivity United Therapeutics Corporation
68 T.W. Alexander Drive, PO Box 14186
Research Triangle Park NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Beta alethine

Trade Name:
Betathine Orphan Designation:
Treatment of metastatic melanoma.

Designation
3/24/1997 Sponsor and Address
Marketing Exclusivity Dovetail Technologies, Inc.
Bldg. 337, Paint Branch Drive
College Park MD 20742

***************************************************************************************
Generic Name Approved Orphan Indication:
Beta alethine

Trade Name:
Betathine Orphan Designation:
Treatment of multiple myeloma.

Designation
3/24/1997 Sponsor and Address
Marketing Exclusivity Dovetail Technologies, Inc.
Bldg. 337, Paint Branch Drive
College Park MD 20742

***************************************************************************************
Generic Name Approved Orphan Indication:
Betaine Treatment of homocystinuria to decrease elevated homocysteine
blood levels.

Trade Name:
Cystadane Orphan Designation:
Treatment of homocystinuria.

Designation
5/16/1994 Sponsor and Address
Marketing Exclusivity Jazz Pharmaceuticals
10/25/1996 3180 Porter Drive
Palo Alto CA 94304

***************************************************************************************
Generic Name Approved Orphan Indication:
Bethanidine sulfate

Trade Name:
Orphan Designation:
Prevention of recurrence of primary ventricular fibrillation.

Designation
11/24/1989 Sponsor and Address
Marketing Exclusivity Medco Research, Inc.
8455 Beverly Blvd.
Suite 308
Los Angeles CA 90048
***************************************************************************************
Generic Name Approved Orphan Indication:
Bethanidine sulfate

Trade Name:
Orphan Designation:
Treatment of primary ventricular fibrillation.

Designation
9/20/1988 Sponsor and Address
Marketing Exclusivity Medco Research, Inc.
8455 Beverly Blvd.
Suite 308
Los Angeles CA 90048
***************************************************************************************
Generic Name Approved Orphan Indication:
Betulinic acid

Trade Name:
Orphan Designation:
Topical treatment of metastatic melanoma

Designation
8/9/2007 Sponsor and Address
Marketing Exclusivity Advanced Life Sciences, Inc. (ALS)
1440 Davey Road
Woodridge IL 60517

***************************************************************************************
Generic Name Approved Orphan Indication:
Bevacizamub

Trade Name:
Avastin Orphan Designation:
Treatment of malignant glioma

Designation
5/26/2006 Sponsor and Address
Marketing Exclusivity Genentech, Inc.
1 DNA Way
South San Francisco CA 94080-4990

***************************************************************************************
Generic Name Approved Orphan Indication:
Bevacizumab

Trade Name:
Avastin Orphan Designation:
Therapeutic treatment of patients with ovarian cancer

Designation
2/9/2006 Sponsor and Address
Marketing Exclusivity Genentech, Inc.
1 DNA Way
South San Francisco CA 94080-4990

***************************************************************************************
Generic Name Approved Orphan Indication:
Bevacizumab

Trade Name:
Avastin Orphan Designation:
Treatment of pancreatic cancer

Designation
10/20/2004 Sponsor and Address
Marketing Exclusivity Genentech, Inc.
1 DNA Way, MS #242
South San Francisco CA 94080-4990

***************************************************************************************
Generic Name Approved Orphan Indication:
Bevacizumab

Trade Name:
Avastin Orphan Designation:
Treatment of renal cell carcinoma

Designation
11/6/2003 Sponsor and Address
Marketing Exclusivity Genentech, Inc.
1 DNA Way
South San Francisco CA 94080-4990

***************************************************************************************
Generic Name Approved Orphan Indication:
Bexarotene Treatment of cutaneous manifestations of cutaneous T-cell
lymphoma in patients who are refractory to at least one prior systemic
therapy.
Trade Name:
Targretin Orphan Designation:
Treatment of cutaneous manifestations of cutaneous T-cell
lymphoma in patients who are refractory to at least one prior systemic
Designation therapy.
6/18/1999 Sponsor and Address
Marketing Exclusivity Eisai Medical Research, Inc.
12/29/1999 55 Challenger Road
Ridgefield Park NJ 07660

***************************************************************************************
Generic Name Approved Orphan Indication:
bifidobacterium longum infantis 35624

Trade Name:
Orphan Designation:
Treatment of pediatric Crohn's disease

Designation
1/16/2003 Sponsor and Address
Marketing Exclusivity Alimentary Health Limited
Guardwell, Kinsale
County Cork

IRELAND
***************************************************************************************
Generic Name Approved Orphan Indication:
Bindarit

Trade Name:
Orphan Designation:
Treatment of lupus nephritis.

Designation
2/3/1998 Sponsor and Address
Marketing Exclusivity Angelini Pharmaceuticals, Inc.
70 Grand Avenue
Suite 109
River Edge NJ 07661
***************************************************************************************
Generic Name Approved Orphan Indication:
Bioartificial liver system utilizing xenogenic
hepatocytes in a hollow fiber bioreactor cartridge

Trade Name:
Orphan Designation:
Treatment of patients with acute liver failure presenting with
encephalopathy deteriorating beyond Parson's grade 2
Designation
2/11/2002 Sponsor and Address
Marketing Exclusivity Excorp Medical, Inc.
Suite 235
7200 Hudson Blvd.
Oakdale MN 55128
***************************************************************************************
Generic Name Approved Orphan Indication:
biocarbonate infusate Use as a replacement solution in Continuous Renal Replacement
Therapy (CRRT) to replace water and to correct electrolytes and acid-
base imbalances in adults and children
Trade Name:
Normocarb HF Orphan Designation:
Use in the management of patients undergoing continuous renal
replacement therapy with hemofiltration
Designation
8/9/2005 Sponsor and Address
Marketing Exclusivity Dialysis Solutions, Inc.
7/26/2006 14 Emmett Place
Whitby, Ontario L1R 2B4

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Bio-engineered oral mucosal tissue

Trade Name:
Orphan Designation:
For use as a graft for restoring a cornea-like epithelial phenotype to
substitute for the normal corneal epithelium that is lost in patients
Designation due to total limbal stem cell deficiency
4/27/2006 Sponsor and Address
Marketing Exclusivity TissueTech, Inc.
7000 SW 97th Avenue
Miami FL 33173

***************************************************************************************
Generic Name Approved Orphan Indication:
Bis(4-fluorophenyl)phenylacetamide

Trade Name:
Orphan Designation:
Treatment of sickle cell disease.

Designation
3/2/2000 Sponsor and Address
Marketing Exclusivity ICAgen Inc.
Ion Channel Advances
PO Box 14487
Durham NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Bispecific molucule with two linked murine single-
chain Fv regions directed against CD3 & CD19

Trade Name:
Orphan Designation:
Treatment of indolent B-cell lymphoma, excluding CLL and NHL with
CNS involvement
Designation
2/6/2006 Sponsor and Address
Marketing Exclusivity MedImmune Oncology, Inc.
One MedImmune Way
Gaithersburg MD 20878

***************************************************************************************
Generic Name Approved Orphan Indication:
bivalirudin

Trade Name:
Angiomax Orphan Designation:
For use as an anticoagulant in patients with or at risk of heparin-
induced thrombocytopenia/heparin-induced thrombocytopenia
Designation thrombosis syndrome
11/2/2005 Sponsor and Address
Marketing Exclusivity The Medicines Company
8 Campus Drive
Parsippany NJ 07054

***************************************************************************************
Generic Name Approved Orphan Indication:
Bleomycin

Trade Name:
Blenoxane Orphan Designation:
Treatment of pancreatic cancer.

Designation
2/9/1999 Sponsor and Address
Marketing Exclusivity Genetronics, Inc.
11199 Sorrento Valley Rd.
San Diego CA 92121-1334

***************************************************************************************
Generic Name Approved Orphan Indication:
Bleomycin sulfate Treatment of malignant pleural effusion.

Trade Name:
Blenoxane Orphan Designation:
Treatment of malignant pleural effusion.

Designation
9/17/1993 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Pharmaceutical Research Institute
2/20/1996 P.O. Box 4000
Princeton NJ 08543

***************************************************************************************
Generic Name Approved Orphan Indication:
BMY-45622

Trade Name:
Orphan Designation:
Treatment of ovarian cancer.

Designation
10/15/1990 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb
5 Research Parkway
Wallingford CT 06492

***************************************************************************************
Generic Name Approved Orphan Indication:
Bortezomib Treatment of multiple myeloma patients who have received at least
one prior therapy

Trade Name:
Velcade Orphan Designation:
Treatment of multiple myeloma

Designation
1/15/2003 Sponsor and Address
Marketing Exclusivity Millennium Pharmaceuticals, Inc.
3/25/2005 40 Landsdowne Street
Canbridge MA 02139

***************************************************************************************
Generic Name Approved Orphan Indication:
Bosentan Treatment of pulmonary arterial hypertension.

Trade Name:
Tracleer Orphan Designation:
Treatment of pulmonary arterial hypertension.

Designation
10/6/2000 Sponsor and Address
Marketing Exclusivity Actelion Life Sciences Ltd.
11/20/2001 1840 Gateway Dr.
2nd Floor
San Mateo CA 94404
***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type A

Trade Name:
Dysport Orphan Designation:
Treatment of dynamic muscle contractures in pediatric cerebral palsy
patients.
Designation
10/20/1999 Sponsor and Address
Marketing Exclusivity Ipsen Limited
1 Bath Rd., Maidenhead
Berkshire SL6 4UH

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type A

Trade Name:
Dysport Orphan Designation:
Treatment of spasmodic torticollis (cervical dystonia).

Designation
8/12/1998 Sponsor and Address
Marketing Exclusivity Ipsen Limited
1 Bath Road
Maidenhead
Berkshire, SL6 4UH
UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type A

Trade Name:
Dysport Orphan Designation:
Treatment of essential blepharospasm.

Designation
3/23/1989 Sponsor and Address
Marketing Exclusivity Porton International, Inc.
1155 15th Street, N.W., #315
Washington DC 20005

***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type A

Trade Name:
Botox Orphan Designation:
Treatment of dynamic muscle contracture in pediatric cerebral palsy
patients.
Designation
12/6/1991 Sponsor and Address
Marketing Exclusivity Allergan, Inc.
2525 Dupont Drive
P.O. Box 19534
Irvine CA 92623-9534
***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type A

Trade Name:
Orphan Designation:
Treatment of synkinetic closure of the eyelid associated with VII
cranial nerve aberrant regeneration.
Designation
9/15/1992 Sponsor and Address
Marketing Exclusivity Botulinum Toxin Research Associates, Inc.
1261 Furnace Brook Parkway
Quincy MA 02169

***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type A Treatment of cervical dystonia in adults to decrease the severity of
abnormal head position and neck pain associated with cervical
dystonia.
Trade Name:
Botox Orphan Designation:
Treatment of cervical dystonia.

Designation
8/20/1986 Sponsor and Address
Marketing Exclusivity Allergan, Inc.
12/21/2000 2525 Dupont Drive
P.O. Box 19534
Irvine CA 92623-9534
***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type A

Trade Name:
Botox Orphan Designation:
Treatment of strabismus associated with dystonia in adults (patients
12 years of age and above).
Designation
3/22/1984 Sponsor and Address
Marketing Exclusivity Allergan, Inc.
12/29/1989 2525 Dupont Drive
P.O. Box 19534
Irvine CA 92713
***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type A

Trade Name:
Botox Orphan Designation:
Treatment of blepharospasm associated with dystonia in adults
(patients 12 years of age and above).
Designation
3/22/1984 Sponsor and Address
Marketing Exclusivity Allergan, Inc.
12/29/1989 2525 Dupont Drive
P.O. Box 19534
Irvine CA 92713
***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type B Treatment of patients with cervical dystonia to reduce the severity of
abnormal head position and neck pain associated with cervical
dystonia.
Trade Name:
Myobloc Orphan Designation:
Treatment of cervical dystonia.

Designation
1/16/1992 Sponsor and Address
Marketing Exclusivity Elan Pharmaceuticals, Inc.
12/8/2000 800 Gateway Blvd.
South San Francisco CA 94080

***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type F

Trade Name:
Orphan Designation:
Treatment of spasmodic torticollis (cervical dystonia).

Designation
10/24/1991 Sponsor and Address
Marketing Exclusivity Ipsen Limited
27 Maple Street
Milford MA 01757-3650

***************************************************************************************
Generic Name Approved Orphan Indication:
Botulinum toxin type F

Trade Name:
Orphan Designation:
Treatment of essential blepharospasm.

Designation
12/5/1991 Sponsor and Address
Marketing Exclusivity Ipsen Limited (name changed from Porton International Inc)
27 Maple Street
Milford MA 01757-3650

***************************************************************************************
Generic Name Approved Orphan Indication:
Botulism immune globulin Indicated for treatment of infant botulism caused by type A or type B
Clostridium botulinum.

Trade Name:
BabyBIG Orphan Designation:
Treatment of infant botulism.

Designation
1/31/1989 Sponsor and Address
Marketing Exclusivity California Department of Health Services
10/23/2003 2151 Berkeley Way
Berkeley CA 94704-1011

***************************************************************************************
Generic Name Approved Orphan Indication:
Bovine colostrum

Trade Name:
Orphan Designation:
Treatment of AIDS-related diarrhea.

Designation
11/19/1990 Sponsor and Address
Marketing Exclusivity Hastings, Donald DVM
1030 North Parkview Drive
Bismarck ND 58501

***************************************************************************************
Generic Name Approved Orphan Indication:
Bovine immunoglobulin concentrate,
Cryptosporidium parvum

Trade Name:
Sporidin-G Orphan Designation:
Treatment and symptomatic relief of Cryptosporidium parvum
infection of the gastrointestinal tract in immunocompromised patients.
Designation
3/1/1994 Sponsor and Address
Marketing Exclusivity GalaGen, Inc.
4001 Lexington Avenue North
Arden Hills MN 55126

***************************************************************************************
Generic Name Approved Orphan Indication:
Bovine whey protein concentrate

Trade Name:
Immuno-C Orphan Designation:
Treatment of cryptosporidiosis caused by the presence of
Cryptosporidium parvum in the gastrointestinal tract of patients who
Designation are immunodeficient/immunocompromised or immunocompetent.
9/30/1993 Sponsor and Address
Marketing Exclusivity Biomune Systems, Inc.
540 Arapeen Drive, Suite 202
Salt Lake City UT 84108

***************************************************************************************
Generic Name Approved Orphan Indication:
Branched chain amino acids

Trade Name:
Orphan Designation:
Treatment of amyotrophic lateral sclerosis.

Designation
12/23/1988 Sponsor and Address
Marketing Exclusivity Mount Sinai Medical Center
One Gustave L. Levy Place
New York NY 10029

***************************************************************************************
Generic Name Approved Orphan Indication:
Brimonidine

Trade Name:
Alphagan Orphan Designation:
Treatment of anterior ischemic optic neuropathy.

Designation
2/7/2000 Sponsor and Address
Marketing Exclusivity Allergan, Inc.
2525 Dupont Dr.
P.O. Box 19534
Irvine CA 92623-9534
***************************************************************************************
Generic Name Approved Orphan Indication:
Brivaracetam

Trade Name:
Orphan Designation:
Treatment of symtomatic myoclonus

Designation
10/5/2005 Sponsor and Address
Marketing Exclusivity UCB Pharma, Inc.
1950 Lake Park Drive
Smyra GA 30080

***************************************************************************************
Generic Name Approved Orphan Indication:
Bromhexine

Trade Name:
Bisolvon Orphan Designation:
Treatment of mild to moderate keratoconjunctivitis sicca in patients
with Sjogren's syndrome.
Designation
5/15/1989 Sponsor and Address
Marketing Exclusivity Boehringer Ingelheim Pharmaceuticals, Inc.
900 Ridgebury Road, Box 368
Ridgefield CT 06877-0368

***************************************************************************************
Generic Name Approved Orphan Indication:
Broxuridine

Trade Name:
Broxine/Neomark Orphan Designation:
Radiation sensitizer in the treatment of primary brain tumors.

Designation
9/18/1995 Sponsor and Address
Marketing Exclusivity NeoPharm, Inc.
225 East Deerpath, Suite 250
Lake Forest IL 60045

***************************************************************************************
Generic Name Approved Orphan Indication:
bryostatin-1

Trade Name:
Orphan Designation:
For use in combination with paclitaxel in the treatment of
esophageal cancer
Designation
12/3/2001 Sponsor and Address
Marketing Exclusivity GPC Biotech, Inc.
610 Lincoln Street
Waltham MA 02451

***************************************************************************************
Generic Name Approved Orphan Indication:
Buffered intrathecal electrolyte/dextrose injection For the intrathecal administration of methotrexate and cytarabine for
the prevention or treatment of meningeal leukemia and lymphocytic
lymphoma.
Trade Name:
Elliotts B Solution Orphan Designation:
For use as a diluent in the intrathecal administration of methotrexate
and cytarabine for the prevention or treatment meningeal leukemia
Designation and lymphocytic lymphoma.
8/24/1994 Sponsor and Address
Marketing Exclusivity QOL Medical, LLC
9/27/1996 12419 198th Drive, NE
Woodinville WA 98072

***************************************************************************************
Generic Name Approved Orphan Indication:
Buffered Ursodeoxycholic Acid

Trade Name:
Ursocarb Orphan Designation:
For the treatment of pruritus in patients with Alagille Syndrome

Designation
9/3/2004 Sponsor and Address
Marketing Exclusivity Digestive Care, Inc.
1120 Win Drive
Bethlehem PA 18017

***************************************************************************************
Generic Name Approved Orphan Indication:
Buprenorphine hydrochloride Treatment of opioid dependence in patients 16 years of age or older

Trade Name:
Subutex Orphan Designation:
Treatment of opiate addiction in opiate users.

Designation
6/15/1994 Sponsor and Address
Marketing Exclusivity Reckitt Benckiser Pharmaceuticals, Inc.
10/8/2002 1901 Huguenot Road
Richmond VA 23235

***************************************************************************************
Generic Name Approved Orphan Indication:
Buprenorphine in combination with naloxone Treatment of opioid dependence in patients 16 years of age or older

Trade Name:
Suboxone Orphan Designation:
Treatment of opiate addiction in opiate users.

Designation
10/27/1994 Sponsor and Address
Marketing Exclusivity Reckitt Benckiser Pharmaceuticals, Inc.
10/8/2002 1901 Huguenot Road
Richmond VA 23235

***************************************************************************************
Generic Name Approved Orphan Indication:
Busulfan For use in combination with cyclophosphamide as a conditioning
regimen prior to allogeneic hematopoietic progenitor cell
transplantation for chronic myelogenous leukemia.
Trade Name:
Busulfex Orphan Designation:
As preparative therapy in the treatment of malignancies with bone
marrow transplantation.
Designation
7/28/1994 Sponsor and Address
Marketing Exclusivity PDL BioPharma, Inc..
2/4/1999 34801 Campus Drive
Fremont CA 94555

***************************************************************************************
Generic Name Approved Orphan Indication:
Busulfan

Trade Name:
Spartaject Orphan Designation:
For use as preparative therapy for malignancies treated with bone
marrow transplantation.
Designation
4/21/1994 Sponsor and Address
Marketing Exclusivity Sparta Pharmaceuticals, Inc.
111 Rock Road
Horsham PA 19044-2310

***************************************************************************************
Generic Name Approved Orphan Indication:
Busulfan

Trade Name:
Spartajet-Busulfan Orphan Designation:
Intrathecal therapy for neoplastic meningitis

Designation
3/5/2001 Sponsor and Address
Marketing Exclusivity SuperGen, Inc.
4140 Dublin Boulevard
Dublin CA 94568

***************************************************************************************
Generic Name Approved Orphan Indication:
busulfan

Trade Name:
Partaject Orphan Designation:
Preparative therapy for pediatric patients undergoing bone marrow
transplantation
Designation
11/25/2002 Sponsor and Address
Marketing Exclusivity SuperGen, Inc.
4140 Dublin Blvd
Suite 200
Dublin CA 94568
***************************************************************************************
Generic Name Approved Orphan Indication:
Busulfan

Trade Name:
Spartaject Orphan Designation:
Treatment of primary brain malignancies.

Designation
7/7/1997 Sponsor and Address
Marketing Exclusivity SuperGen, Inc.
Two Annabel Lane, Suite 220
San Ramon CA 94583

***************************************************************************************
Generic Name Approved Orphan Indication:
Buthionine sulfoxamine

Trade Name:
Orphan Designation:
For use in children as a modulator of chemotherapy for the treatment
of pediatric patients with neuroblastoma
Designation
10/5/2005 Sponsor and Address
Marketing Exclusivity USC-CHLA Institute for Pediatric Clinical Research
Childrens Hospital of Los Angeles MS 55
Los Angeles CA 90027

***************************************************************************************
Generic Name Approved Orphan Indication:
Buthionine sulfoxamine

Trade Name:
Orphan Designation:
Use as a modulator of chemotherapy for the treatment of pediatric
patients with primary malignant brain tumors
Designation
10/5/2005 Sponsor and Address
Marketing Exclusivity USC-CHLA Institute for Pediatric Clinical Research
Childrens Hospital of Los Angeles
4650 Sunset Blvd, MS 55
Los Angeles CA 90027
***************************************************************************************
Generic Name Approved Orphan Indication:
Butyrylcholinesterase

Trade Name:
Orphan Designation:
Treatment of post-surgical apnea.

Designation
9/30/1992 Sponsor and Address
Marketing Exclusivity Shire Laboratories Inc.
1550 East Gude Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
Butyrylcholinesterase

Trade Name:
Orphan Designation:
For the reduction and clearance of toxic blood levels of cocaine
encountered during a drug overdose.
Designation
3/25/1992 Sponsor and Address
Marketing Exclusivity Shire Laboratories Inc.
1550 East Gude Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
BW 12C

Trade Name:
Orphan Designation:
Treatment of sickle cell disease.

Designation
10/23/1987 Sponsor and Address
Marketing Exclusivity Burroughs Wellcome Company
3030 Cornwallis Road
P.O. Box 12700
Research Triangle Pk NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
C1 esterase inhibitor (human)

Trade Name:
Orphan Designation:
Treatment of angioedema

Designation
7/16/2004 Sponsor and Address
Marketing Exclusivity Lev Pharmaceuticals, Inc.
236 Old Lancaster Road
Merion Station PA 19066

***************************************************************************************
Generic Name Approved Orphan Indication:
C1 esterase inhibitor (human)

Trade Name:
Orphan Designation:
Treatment and prevention of angioedema caused by C1-esterase
inhibitor deficiency.
Designation
8/21/1996 Sponsor and Address
Marketing Exclusivity Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles CA 90032

***************************************************************************************
Generic Name Approved Orphan Indication:
C1-esterase-inhibitor, human, pasteurized

Trade Name:
Berinert P Orphan Designation:
Prevention and/or treatment of acute attacks of hereditary
angioedema.
Designation
10/16/1992 Sponsor and Address
Marketing Exclusivity Aventis Behring L.L.C.
1020 First Ave.
PO Box 61501
King of Prussia PA 19406-0901
***************************************************************************************
Generic Name Approved Orphan Indication:
C1-inhibitor

Trade Name:
C1-inhibitor (human) vapor heated, Immuno Orphan Designation:
Prevention of acute attacks of angioedema, including short-term
prophylaxis for patients requiring dental or other surgical procedures.
Designation
8/30/1990 Sponsor and Address
Marketing Exclusivity Baxter Healthcare Corp.
One Baxter Way
Westlake Village CA 91362

***************************************************************************************
Generic Name Approved Orphan Indication:
C1-inhibitor

Trade Name:
C1-inhibitor (human) vapor heated, Immuno Orphan Designation:
Treatment of acute attacks of angioedema.

Designation
8/30/1990 Sponsor and Address
Marketing Exclusivity Baxter Healthcare Corp.
Hyland Division (Baxter Hyland)
550 North Brand Blvd.
Glendale CA 91203
***************************************************************************************
Generic Name Approved Orphan Indication:
cAC10-vcMMAE (4)

Trade Name:
Orphan Designation:
Treatment of Hodgkin's lymphoma.

Designation
1/30/2007 Sponsor and Address
Marketing Exclusivity Seattle Genetics, Inc.
21823 30th Drive Southeast
Bothell WA 98021

***************************************************************************************
Generic Name Approved Orphan Indication:
Caffeine Short term treatment of apnea of prematurity in infants between 28
and less than 33 weeks gestational age.

Trade Name:
Cafcit Orphan Designation:
Treatment of apnea of prematurity.

Designation
9/20/1988 Sponsor and Address
Marketing Exclusivity O.P.R. Development, L.P.
9/21/1999 1501 Wakarusa Drive
Lawrence KS 66047

***************************************************************************************
Generic Name Approved Orphan Indication:
Calcitonin salmon nasal spray

Trade Name:
Miacalcin Nasal Spray Orphan Designation:
Treatment of symptomatic Paget's disease (osteitis deformans).

Designation
10/29/1990 Sponsor and Address
Marketing Exclusivity Sandoz Pharmaceuticals Corp.
59 Route 10
East Hanover NJ 07936

***************************************************************************************
Generic Name Approved Orphan Indication:
Calcitonin-human for injection

Trade Name:
Cibacalcin Orphan Designation:
Treatment of symptomatic Paget's disease (osteitis deformans).

Designation
1/20/1987 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceutical Corporation
10/31/1986 59 Route 10
East Hanover NJ 07936

***************************************************************************************
Generic Name Approved Orphan Indication:
Calcium acetate

Trade Name:
Phos-Lo Orphan Designation:
Treatment of hyperphosphatemia in end stage renal failure.

Designation
12/22/1988 Sponsor and Address
Marketing Exclusivity Braintree Laboratories
12/10/1990 60 Columbian Street
P.O. Box 361
Braintree MA 02184
***************************************************************************************
Generic Name Approved Orphan Indication:
Calcium acetate

Trade Name:
Orphan Designation:
Treatment of hyperphosphatemia in end stage renal disease.

Designation
6/27/1989 Sponsor and Address
Marketing Exclusivity Pharmedic Company
28101 Ballard Road, Suite F
Lake Forest IL 60045

***************************************************************************************
Generic Name Approved Orphan Indication:
Calcium carbonate

Trade Name:
R & D calcium carbonate/600 Orphan Designation:
Treatment of hyperphosphatemia in patients with end stage renal
disease.
Designation
6/6/1990 Sponsor and Address
Marketing Exclusivity R & D Laboratories, Inc.
4204 Glencoe Avenue
Marina Del Rey CA 90292

***************************************************************************************
Generic Name Approved Orphan Indication:
Calcium gluconate

Trade Name:
Calgonate Orphan Designation:
For use as a wash for hydrofluoric acid spills on human skin.

Designation
11/20/1997 Sponsor and Address
Marketing Exclusivity Calgonate Corp.
190 Commerce Drive
Warwick RI 02886

***************************************************************************************
Generic Name Approved Orphan Indication:
Calcium gluconate gel

Trade Name:
H-F Gel Orphan Designation:
For use in the emergency topical treatment of hydrogen fluoride
(hydrofluoric acid) burns.
Designation
5/21/1991 Sponsor and Address
Marketing Exclusivity LTR Pharmaceuticals, Inc.
145 Sakonnet Blvd.
Narragansett RI 02882

***************************************************************************************
Generic Name Approved Orphan Indication:
Calcium gluconate gel 2.5%

Trade Name:
Orphan Designation:
Emergency topical treatment of hydrogen fluoride (hydrofluoric acid)
burns.
Designation
9/10/1990 Sponsor and Address
Marketing Exclusivity Paddock Laboratories, Inc.
3940 Quebec Avenue North
Minneapolis MN 55427

***************************************************************************************
Generic Name Approved Orphan Indication:
Calfactant

Trade Name:
Infasurf Orphan Designation:
Acute respiratory distress syndrome (ARDS)

Designation
9/5/2000 Sponsor and Address
Marketing Exclusivity Pneuma Partners, LLC
1576 Sweet Home Road
Amherst NY 14228

***************************************************************************************
Generic Name Approved Orphan Indication:
Capsaicin

Trade Name:
Orphan Designation:
Treatment of postherpetic neuralgia.

Designation
8/3/2005 Sponsor and Address
Marketing Exclusivity TheraQuest Biosciences, LLC
146 Medinah Drive
Blue Bell PA 19422-3212

***************************************************************************************
Generic Name Approved Orphan Indication:
Capsaicin

Trade Name:
Orphan Designation:
Treatment of intermetatarsal neuroma (Morton's Neuroma) that does
not respond to conservative treatment and requires either neurectomy
Designation or neurolysis
9/29/2006 Sponsor and Address
Marketing Exclusivity Anesiva, Inc.
650 Gateway Blvd
South San Francisco CA 94080

***************************************************************************************
Generic Name Approved Orphan Indication:
capsaicin

Trade Name:
Orphan Designation:
Treatment of erythromelalgia

Designation
10/23/2002 Sponsor and Address
Marketing Exclusivity NeurogesX, Inc.
981F Industrial Road
San Carlos CA 94070

***************************************************************************************
Generic Name Approved Orphan Indication:
Capsaicin

Trade Name:
Orphan Designation:
Treatment of painful HIV-associated neuropathy

Designation
5/2/2003 Sponsor and Address
Marketing Exclusivity NeurogesX, Inc.
San Carlos Business Park
981F Industrial Road
San Carols CA 94070-4117
***************************************************************************************
Generic Name Approved Orphan Indication:
Carbamylglutamic acid

Trade Name:
Orphan Designation:
Treatment of N-acetylglutamate synthetase deficiency.

Designation
1/20/1998 Sponsor and Address
Marketing Exclusivity Orphan Europe
Immeuble "Le Guillaumet"
60, avenue du General de Gaulle

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
Carbovir

Trade Name:
Orphan Designation:
Treatment of persons with AIDS and in patients with symptomatic HIV
infection and a CD4 count less than 200/mm3.
Designation
12/13/1989 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Inc.
5 Moore Drive
Research Triangle Park NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Carmustine

Trade Name:
Orphan Designation:
Treatment of intracranial malignancies.

Designation
7/3/2000 Sponsor and Address
Marketing Exclusivity Direct Therapeutics, Inc.
460 Seaport Court
Suite 220
Redwood CA 94063
***************************************************************************************
Generic Name Approved Orphan Indication:
Cascara sagrada fluid extract

Trade Name:
Orphan Designation:
Treatment of oral drug overdosage to speed lower bowel evacuation.

Designation
3/21/1989 Sponsor and Address
Marketing Exclusivity Intramed Corporation
102 Tremont Way
Augusta GA 30907

***************************************************************************************
Generic Name Approved Orphan Indication:
Catumaxomab

Trade Name:
Removab Orphan Designation:
Treatment of ovarian cancer

Designation
6/9/2006 Sponsor and Address
Marketing Exclusivity Fresenius Biotech North America, Inc.
99 Hayden Avenue
Lexington MA 02420-9192

***************************************************************************************
Generic Name Approved Orphan Indication:
CD4 human truncated 369 AA polypeptide

Trade Name:
Soluble T4 Orphan Designation:
Treatment of acquired immunodeficiency syndrome.

Designation
11/21/1989 Sponsor and Address
Marketing Exclusivity SmithKline Beecham
Route 23 & Woodmont Ave., P.O. Box 1510
King Of Prussia PA 19406

***************************************************************************************
Generic Name Approved Orphan Indication:
CD5-T lymphocyte immunotoxin

Trade Name:
Xomazyme-H65 Orphan Designation:
Treatment of graft versus host disease and/or rejection in patients
who have received bone marrow transplants.
Designation
8/27/1987 Sponsor and Address
Marketing Exclusivity Xoma Corporation
2910 Seventh Street
Berkeley CA 94710

***************************************************************************************
Generic Name Approved Orphan Indication:
CDP571

Trade Name:
Orphan Designation:
Treatment of Crohn's disease.

Designation
12/11/1997 Sponsor and Address
Marketing Exclusivity Celltech Chiroscience Limited
216 Bath Road
Slough SL1 4EN

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Ceftriaxone sodium

Trade Name:
Rocephin Orphan Designation:
Treatment of amyotrophic lateral sclerosis

Designation
3/28/2006 Sponsor and Address
Marketing Exclusivity Mass General Hospital
Merit E. Cudkowicz, MD, MSc
Building 149 13th Street, Room 2274
Charlestown MA 02129
***************************************************************************************
Generic Name Approved Orphan Indication:
Cells produced using the AastromReplicelle System
and SC-I Therapy Kit

Trade Name:
Orphan Designation:
For use in patients receiving high dose chemotherapy who are
unable to generate an acceptable dose of peripheral blood stem
Designation cells and who have a sufficient bone marrow aspirate without
7/10/2002 Sponsor and Address morphological evidence of tumor
Marketing Exclusivity Aastrom Biosciences Incorporated
P.O. Box 376
Ann Arbor MI 48106

***************************************************************************************
Generic Name Approved Orphan Indication:
Cenersen sodium

Trade Name:
Orphan Designation:
Treatment of acute myeloid leukemia

Designation
5/8/2006 Sponsor and Address
Marketing Exclusivity ELEOS, Inc.
7824 Jackson Street
Omaha NE 68114

***************************************************************************************
Generic Name Approved Orphan Indication:
Centruroides immune F(ab)2

Trade Name:
Alacramyn Orphan Designation:
Treatment of scorpion envenomations requiring medical attention.

Designation
6/12/2000 Sponsor and Address
Marketing Exclusivity Silanes Laboratories S.A. de C.V.
Amores #1034 Col Del Valle
C.P. 03100 Mexico D.F.

MEXICO
***************************************************************************************
Generic Name Approved Orphan Indication:
Ceramide trihexosidase/alpha-galactosidase A For use in patients with Fabry disease to reduce
globotriaosylceramide (GL-3) deposition in capillary endothelium of
the kidney and certain other cell types
Trade Name:
Fabrazyme Orphan Designation:
Treatment of Fabry's disease.

Designation
1/19/1988 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
4/24/2003 One Kendall Square
Cambridge MA 02139-1562

***************************************************************************************
Generic Name Approved Orphan Indication:
cethromycin

Trade Name:
Orphan Designation:
Prophylactic treatment of patients exposed to inhalation anthrax.

Designation
2/28/2007 Sponsor and Address
Marketing Exclusivity Advanced LIfe Sciences, Inc.
1440 Davey Road
Woodridge IL 60517

***************************************************************************************
Generic Name Approved Orphan Indication:
Cetiedil citrate injection

Trade Name:
Orphan Designation:
Treatment of sickle cell disease crisis.

Designation
12/22/1988 Sponsor and Address
Marketing Exclusivity Baker Cummins Pharmaceuticals, Inc.

***************************************************************************************
Generic Name Approved Orphan Indication:
cetuximab

Trade Name:
Erbitux Orphan Designation:
Treatment of pancreatic cancer

Designation
6/15/2007 Sponsor and Address
Marketing Exclusivity ImClone Systems Incorporated
33 ImClone Drive
Branchburg NJ 08876

***************************************************************************************
Generic Name Approved Orphan Indication:
Cetuximab For use in combination with radiation therapy, for the treatment of
locally or regionally advanced squamous cell carcinoma of the head
and neck (SCCHN) and for use as a single agent for the treatment of
Trade Name: patients with recurrent or metastatic SCCHN for whom prior platinum-
based therapy has failed
Erbitux Orphan Designation:
Treatment of squamous cell cancer of the head and neck in patients
who express epidermal growth factor receptor.
Designation
7/3/2000 Sponsor and Address
Marketing Exclusivity ImClone Systems Incorporated
3/1/2006 33 ImClone Drive
Branchburg NJ 08876

***************************************************************************************
Generic Name Approved Orphan Indication:
Chenodeoxycholic acid

Trade Name:
Chenofalk Orphan Designation:
Treatment of cerebrotendinous xanthomatosis

Designation
1/29/2004 Sponsor and Address
Marketing Exclusivity Dr. Falk Pharma GmbH
Leinenweberstrasse 5
9041 Freiburg, GERMANY

GERMANY
***************************************************************************************
Generic Name Approved Orphan Indication:
chenodeoxycholic acid

Trade Name:
Orphan Designation:
Treatment of cerebrotendinous xanthomatosis

Designation
2/12/2007 Sponsor and Address
Marketing Exclusivity Sigma Tau
800 South Frederik Avenue, Suite 300
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Chenodiol

Trade Name:
Chenix Orphan Designation:
For patients with radiolucent stones in well opacifying gallbladders,
in whom elective surgery would be undertaken except for the
Designation presence of increased surgical risk due to systemic disease or age.
9/21/1984 Sponsor and Address
Marketing Exclusivity Solvay
7/28/1983 901 Sawyer Road
Marietta GA 30062

***************************************************************************************
Generic Name Approved Orphan Indication:
Chimeric (human-murine) G250 IgG monoclonal
antibody
Trade Name:
Orphan Designation:
Treatment of renal cell carcinoma.

Designation
7/24/2000 Sponsor and Address
Marketing Exclusivity Wilex Biotechnology GmbH
Grillparzerstrasse 10B
81675 Munich

GERMANY
***************************************************************************************
Generic Name Approved Orphan Indication:
chimeric (murine-human) IgG1 mAb against IL-6

Trade Name:
Orphan Designation:
Treatment of multiple myeloma

Designation
10/11/2005 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
Chimeric (murine-human) IgG1k monoclonal
antibody against interleukin-6

Trade Name:
Orphan Designation:
Treatment of Castleman's disease

Designation
5/26/2006 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
Chimeric monoclonal antibodies

Trade Name:
Orphan Designation:
For treatment of shiga-toxin producing bacterial infection.

Designation
10/4/2005 Sponsor and Address
Marketing Exclusivity Caprion Pharmaceuticals, Inc.
7150 Alexander-Fleming

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Chimeric monoclonal antibody to mesothelin

Trade Name:
Orphan Designation:
Treatment of pancreatic cancer

Designation
10/31/2006 Sponsor and Address
Marketing Exclusivity Morphotek, Inc.
210 Welsh Pool Road
Exton PA 19341

***************************************************************************************
Generic Name Approved Orphan Indication:
Chimeric M-T412 (human-murine) IgG monoclonal
anti-CD4

Trade Name:
Orphan Designation:
Treatment of multiple sclerosis.

Designation
6/5/1991 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
244 Great Valley Parkway
Malvern PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Chimeric, humanized monoclonal antibody to
staphylococcus

Trade Name:
Orphan Designation:
Prophylaxis of Staphylococcus epidermidis sepsis in low birth weight
(1500 grams or less) infants.
Designation
8/3/2000 Sponsor and Address
Marketing Exclusivity Biosynexus, Inc.
9298 Gaither Road
Rockville MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Chlorhexidine gluconate mouthrinse

Trade Name:
Peridex Orphan Designation:
For use in the amelioration of oral mucositis associated with
cytoreductive therapy used in conditioning patients for bone marrow
Designation transplantation therapy.
8/18/1986 Sponsor and Address
Marketing Exclusivity Procter & Gamble Company
Sharon Wood Technical Center
11370 Reed Hartman Highway
Cincinnati OH 45241
***************************************************************************************
Generic Name Approved Orphan Indication:
cholic acid (3 alpha, 7 alpha, 12 alpha trihydroxy 5-
beta cholanolic acid)

Trade Name:
Falkochol Orphan Designation:
Treatment of inborn errors of cholesterol and bile acid synthesis and
metabolism
Designation
7/18/2003 Sponsor and Address
Marketing Exclusivity Dr. Falk Pharma GmbH
Leinenweberstrasse 5
Postfach 6529

GERMANY
***************************************************************************************
Generic Name Approved Orphan Indication:
Choline chloride

Trade Name:
Intrachol Orphan Designation:
Treatment of choline deficiency, specifically the choline deficiency,
hepatic steatosis, and cholestasis, associated with long-term
Designation parenteral nutrition.
2/10/1994 Sponsor and Address
Marketing Exclusivity Bioniche Pharma
275, avenue Labrosse
Pointe-Claire

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Choline chloride

Trade Name:
IntraChol Orphan Designation:
Prevention and/or treatment of choline deficiency in patients on
long-term parenteral nutrition
Designation
7/20/2006 Sponsor and Address
Marketing Exclusivity Alan L. Buchman, M.D., M.S.P.H.
Feinberg School of Medicine, Dept. of Gastroentero
676 N. St. Clair St., Suite 1400
Chicago IL 60611
***************************************************************************************
Generic Name Approved Orphan Indication:
Chondrocyte-alginate gel suspension

Trade Name:
Orphan Designation:
For use in correcting vesicoureteral reflux in the pediatric population.

Designation
12/1/1997 Sponsor and Address
Marketing Exclusivity Curis, Inc.
61 Moulton Street
Cambridge MA 02138

***************************************************************************************
Generic Name Approved Orphan Indication:
Chondroitinase

Trade Name:
Orphan Designation:
Treatment of patients undergoing vitrectomy.

Designation
2/9/1995 Sponsor and Address
Marketing Exclusivity Bausch & Lomb Pharmaceuticals, Inc.
8500 Hidden River Pkwy.
Tampa FL 33637

***************************************************************************************
Generic Name Approved Orphan Indication:
cilengitide

Trade Name:
Orphan Designation:
Treatment of malignant glioma

Designation
5/27/2005 Sponsor and Address
Marketing Exclusivity EMD Serono, Inc.
One Technology Place
Rockland MA 02370

***************************************************************************************
Generic Name Approved Orphan Indication:
Ciliary neurotrophic factor

Trade Name:
Orphan Designation:
Treatment of amyotrophic lateral sclerosis.

Designation
1/30/1992 Sponsor and Address
Marketing Exclusivity Regeneron Pharmaceuticals Inc
777 Old Saw Mill River Road
Tarrytown NY 10591

***************************************************************************************
Generic Name Approved Orphan Indication:
Ciliary neurotrophic factor, recombinant human

Trade Name:
Orphan Designation:
Treatment of motor neuron disease (including amyotrophic lateral
sclerosis, progressive muscular atrophy, progressive bulbar palsy, and
Designation primary lateral sclerosis).
5/8/1992 Sponsor and Address
Marketing Exclusivity Syntex-Synergen Neuroscience
3200 Walnut Street
Boulder CO 80301

***************************************************************************************
Generic Name Approved Orphan Indication:
Ciliary neurotrophic factor, recombinant human

Trade Name:
Orphan Designation:
Treatment of spinal muscular atrophies.

Designation
4/2/1992 Sponsor and Address
Marketing Exclusivity Syntex-Synergen Neuroscience
3200 Walnut Street
Boulder CO 80301

***************************************************************************************
Generic Name Approved Orphan Indication:
cinacalcet Treatment of hypercalcemia in patients with parathyroid carcinoma

Trade Name:
Sensipar Orphan Designation:
Treatment of hypercalcemia in patients with parathyroid carcinoma

Designation
5/12/2003 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
3/8/2004
One Amgen Center Drive
Thousand Oaks CA 91320-1799
***************************************************************************************
Generic Name Approved Orphan Indication:
cis-Amminedichloro(2-methylpyridine)platinum(II)

Trade Name:
Orphan Designation:
Treatment of small cell lung cancer.

Designation
11/2/2005 Sponsor and Address
Marketing Exclusivity NeoRx Corporation
300 Elliott Avenue West
Seattle WA 98119

***************************************************************************************
Generic Name Approved Orphan Indication:
Cisplatin in liposomal formulation

Trade Name:
SLIT Cisplatin for inhalation Orphan Designation:
Treatment of osteogenic sarcoma metastatic to the lung

Designation
3/20/2007 Sponsor and Address
Marketing Exclusivity Transave, Inc.
11 Deer Park Drive
Monmouth Junction NJ 08852-1923

***************************************************************************************
Generic Name Approved Orphan Indication:
Cisplatin/epinephrine

Trade Name:
IntraDose Orphan Designation:
Treatment of metastatic malignant melanoma.

Designation
9/7/2000 Sponsor and Address
Marketing Exclusivity Matrix Pharmaceutical, Inc.
34700 Campus Drive
Fremont CA 94555-3612

***************************************************************************************
Generic Name Approved Orphan Indication:
Cisplatin/epinephrine

Trade Name:
IntraDose Orphan Designation:
Treatment of squamous cell carcinoma of the head and neck.

Designation
4/3/2000 Sponsor and Address
Marketing Exclusivity Matrix Pharmaceutical, Inc.
34700 Campus Drive
Fremont CA 94555-3612

***************************************************************************************
Generic Name Approved Orphan Indication:
Citric acid, glucono-delta-lactone and magnesium
carbonate

Trade Name:
Renacidin Irrigation Orphan Designation:
Treatment of renal and bladder calculi of the apatite or struvite
variety.
Designation
8/28/1989 Sponsor and Address
Marketing Exclusivity United-Guardian, Inc.
10/2/1990 P.O. Box 2500
Smithtown NY 11787

***************************************************************************************
Generic Name Approved Orphan Indication:
Civamide

Trade Name:
Zucapsaicin Orphan Designation:
Treatment of postherpetic neuralgia of the trigeminal nerve

Designation
12/9/2002 Sponsor and Address
Marketing Exclusivity Winston Laboratories, Inc.
100 Fairway Drive, Suite 134
Vernon Hills IL 60061

***************************************************************************************
Generic Name Approved Orphan Indication:
Cladribine

Trade Name:
Leustatin Orphan Designation:
Treatment of acute myeloid leukemia.

Designation
7/20/1990 Sponsor and Address
Marketing Exclusivity Johnson & Johnson Pharmaceutical Research & Dev., LLC
920 US Highway 202
P.O. Box 300
Raritan NJ 08869
***************************************************************************************
Generic Name Approved Orphan Indication:
Cladribine

Trade Name:
Leustatin Injection Orphan Designation:
Treatment of hairy cell leukemia.

Designation
11/15/1990 Sponsor and Address
Marketing Exclusivity R. W. Johnson Pharmaceutical Research Institute
2/26/1993 Route 202, P.O. Box 300
Raritan NJ 08869

***************************************************************************************
Generic Name Approved Orphan Indication:
Cladribine

Trade Name:
Leustatin Injection Orphan Designation:
Treatment of chronic lymphocytic leukemia.

Designation
12/31/1990 Sponsor and Address
Marketing Exclusivity R. W. Johnson Pharmaceutical Research Institute
1125 Tenton-Harbourton Road
P. O. Box 200
Titusville NJ 08560
***************************************************************************************
Generic Name Approved Orphan Indication:
Cladribine

Trade Name:
Mylinax Orphan Designation:
Treatment of the chronic progressive form of multiple sclerosis.

Designation
4/19/1994 Sponsor and Address
Marketing Exclusivity Johnson & Johnson Pharmaceutical R & D, LLC
920 Route 202
PO Box 300
Raritan NJ 08869-0602
***************************************************************************************
Generic Name Approved Orphan Indication:
Cladribine

Trade Name:
Leustatin Injection Orphan Designation:
Treatment of non-Hodgkin's lymphoma.

Designation
4/19/1993 Sponsor and Address
Marketing Exclusivity Johnson &Johnson Pharmaceutical Research Institute
Route 202 South, P.O. Box 300
Raritan NJ 08869-0602

***************************************************************************************
Generic Name Approved Orphan Indication:
Clazosentan

Trade Name:
Erajet Orphan Designation:
Treatment of cerebral vasospasm following subarachnoid
hemorrhage
Designation
2/16/2006 Sponsor and Address
Marketing Exclusivity Actelion Pharmaceuticals Ltd.
Gewerbestrasse 16

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
Clindamycin

Trade Name:
Cleocin Orphan Designation:
Prevention of Pneumocystis carinii pneumonia in AIDS patients.

Designation
10/28/1988 Sponsor and Address
Marketing Exclusivity Pfizer Inc.
235 East 42nd Street
150-3-46
New York NY 10017
***************************************************************************************
Generic Name Approved Orphan Indication:
Clindamycin

Trade Name:
Cleocin Orphan Designation:
Treatment of Pneumocystis carinii pneumonia associated with AIDS
patients.
Designation
10/28/1988 Sponsor and Address
Marketing Exclusivity Pharmacia & Upjohn
7000 Portage Road
Unit 0633-298-113
Kalamazoo MI 49001-0199
***************************************************************************************
Generic Name Approved Orphan Indication:
Clindamycin hydrochloride

Trade Name:
Orphan Designation:
Treatment of sarcoidosis

Designation
8/9/2006 Sponsor and Address
Marketing Exclusivity Autoimmunity Research Foundation
3423 Hill Canyon Avenue
Thousand Oaks CA 91360

***************************************************************************************
Generic Name Approved Orphan Indication:
clofarabine

Trade Name:
Clofarex Orphan Designation:
Treatment of acute myelogenous leukemia

Designation
3/14/2002 Sponsor and Address
Marketing Exclusivity Genzyme Corp (Ilex Products, Inc.)
4545 Horizon Hill Blvd.
San Antonio TX 78229-2263

***************************************************************************************
Generic Name Approved Orphan Indication:
clofarabine Treatment of pediatric patients 1 to 21 years old with relapsed or
refractory acute lymphoblastic leukemia after at least two prior
regimens
Trade Name:
Clolar Orphan Designation:
Treatment of acute lymphoblastic leukemia

Designation
2/7/2002 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
12/28/2004 4545 Horizon Hill Blvd.
San Antonio TX 78229-2263

***************************************************************************************
Generic Name Approved Orphan Indication:
Clofazimine

Trade Name:
Lamprene Orphan Designation:
Treatment of lepromatous leprosy, including dapsone-resistant
lepromatous leprosy and lepromatous leprosy complicated by
Designation erythema nodosum leprosum.
6/11/1984 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceutical Corporation
12/15/1986 59 Route 10
East Hanover NJ 07936

***************************************************************************************
Generic Name Approved Orphan Indication:
Clonazepam

Trade Name:
Klonopin Orphan Designation:
Treatment of hyperekplexia (startle disease).

Designation
8/4/1994 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Clonidine In combination with opiates for the treatment of severe pain in cancer
patients that is not adequately relieved by opioid analgesics alone.

Trade Name:
Duraclon Orphan Designation:
For continous epidural administration as adjunctive therapy with
intraspinal opiates for the treatment of pain in cancer patients
Designation tolerant to, or unresponsive to, intraspinal opiates.
1/24/1989 Sponsor and Address
Marketing Exclusivity Roxane Laboratories, Inc.
10/2/1996 PO Box 16532
Columbus OH 43216-6532

***************************************************************************************
Generic Name Approved Orphan Indication:
Clostridial collagenase

Trade Name:
Orphan Designation:
Treatment of advanced (involutional or residual stage) Dupuytren's
disease.
Designation
5/23/1996 Sponsor and Address
Marketing Exclusivity Auxilium Pharmaceuticals, Inc.
40 Valley Stream Parkway
Malvern PA 19335

***************************************************************************************
Generic Name Approved Orphan Indication:
Clotrimazole

Trade Name:
Orphan Designation:
Topical treatment of children and adults with pouchitis

Designation
6/14/2005 Sponsor and Address
Marketing Exclusivity Effective Pharmaceuticals, Inc.
150 Broadway
Suite 1800
New York NY 10038
***************************************************************************************
Generic Name Approved Orphan Indication:
Clotrimazole

Trade Name:
Orphan Designation:
Treatment of Huntington's disease

Designation
3/13/2006 Sponsor and Address
Marketing Exclusivity EnVivo Pharmaceuticals, Inc.
480 Arsenal Street
Watertown MA 02472

***************************************************************************************
Generic Name Approved Orphan Indication:
Clotrimazole

Trade Name:
Orphan Designation:
Treatment of sickle cell disease.

Designation
4/24/1995 Sponsor and Address
Marketing Exclusivity Brugnara, Carlo M.D.
The Children's Hospital
300 Longwood Avenue, Bader 760
Boston MA 02115
***************************************************************************************
Generic Name Approved Orphan Indication:
c-myb antisense oligodeoxynucleotide

Trade Name:
Orphan Designation:
Treatment of chronic myelogenous leukemia

Designation
2/22/2005 Sponsor and Address
Marketing Exclusivity Genta, Inc.
Two Connell Drive
Berkeley Heights NJ 07922

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation factor IX Prevention and control of bleeding in factor IX deficiency, also known
as hemophilia B or Christmas disease.

Trade Name:
Mononine Orphan Designation:
Replacement treatment and prophylaxis of the hemorrhagic
complications of hemophilia B.
Designation
6/27/1989 Sponsor and Address
Marketing Exclusivity Armour Pharmaceutical Company
8/20/1992 500 Arcola Road, P.O. Box 1200
Collegeville PA 19426

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation Factor IX (human)

Trade Name:
AlphaNine Orphan Designation:
For use as replacement therapy in patients with hemophilia B for the
prevention and control of bleeding episodes, and during surgery to
Designation correct defective hemostasis.
7/5/1990 Sponsor and Address
Marketing Exclusivity Alpha Therapeutic Corporation
12/31/1990 5555 Valley Boulevard
Los Angeles CA 90032

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation Factor IX (recombinant) For the control and prevention of hemorrhagic episodes in patients
with hemophilia B (congenital factor IX deficiency and Christmas
disease), including control and prevention of bleeding in surgical
Trade Name: settings.
BeneFix Orphan Designation:
Treatment of hemophilia B.

Designation
10/3/1994 Sponsor and Address
Marketing Exclusivity Genetics Institute, Inc.
2/11/1997 87 Cambridge Park Drive
Cambridge MA 02140

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation factor VIIa (recombinant) Prevention of bleeding in surgical interventions or invasive
procedures in patients with acquired hemophilia

Trade Name:
NovoSeven Orphan Designation:
Prevention of bleeding episodes in patients with acquired inhibitors
to Factor VIII or Factor IX
Designation
7/21/2004 Sponsor and Address
Marketing Exclusivity Novo Nordisk, Inc.
10/13/2006 100 College Road West
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation factor VIIa (recombinant)

Trade Name:
NovoSeven Orphan Designation:
Prevention of bleeding episodes in Glanzmann's thrombasthenia

Designation
6/18/2004 Sponsor and Address
Marketing Exclusivity Novo Nordisk, Inc.
100 College Road West
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation factor VIIa (recombinant) Prevention of bleeding in surgical interventions or invasive
procedures in patients with congenital F VII deficiency

Trade Name:
NovoSeven Orphan Designation:
Prevention of bleeding episodes in patients with congenital Factor
VII
Designation deficiency
9/10/2004 Sponsor and Address
Marketing Exclusivity Novo Nordisk, Inc.
7/11/2005 100 College Road West
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation Factor VIIa (Recombinant) Treatment of bleeding episodes in surgical interventions or invasive
procedures in patients with acquired hemophilia

Trade Name:
NovoSeven Orphan Designation:
Treatment of bleeding episodes in patients with acquired inhibitors to
Factor VIII or Factor IX
Designation
7/16/2004 Sponsor and Address
Marketing Exclusivity Novo Nordisk, Inc.
10/13/2006 100 College Road West
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation factor VIIa (recombinant) Prevention of bleeding in surgical interventions or invasive
procedures in hemophilia A or B patients with inhibitors to Factor VIII
or Factor IX
Trade Name:
NovoSeven Orphan Designation:
Prevention of bleeding episodes in patients with hemophilia A or B,
with or without inhibitors
Designation
6/18/2004 Sponsor and Address
Marketing Exclusivity Novo Nordisk, Inc.
8/12/2005 100 College Road West
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation factor VIIa (Recombinant)

Trade Name:
NovoSeven Orphan Designation:
Treatment of bleeding episodes in Glanzmann's thrombasthenia

Designation
6/18/2004 Sponsor and Address
Marketing Exclusivity Novo Nordisk, Inc.
100 College Road West
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation factor VIIa (recombinant) Treatment of bleeding episodes in patients with Factor VII Deficiency

Trade Name:
NovoSeven Orphan Designation:
Treatment of bleeding episodes in patients with congenital factor VII
deficiency
Designation
9/10/2004 Sponsor and Address
Marketing Exclusivity Novo Nordisk, Inc.
7/11/2005 100 College Road West
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation Factor VIIa (Recombinant)

Trade Name:
NovoSeven Orphan Designation:
Treatment of bleeding in patients experiencing intracranial
hemorrhage.
Designation
10/3/2006 Sponsor and Address
Marketing Exclusivity Novo Nordisk, Inc.
100 College Road West
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Coagulation factor VIIa (recombinant) Treatment of bleeding episodes in hemophilia A or B patients with
inhibitors to Factor VIII or Factor IX.

Trade Name:
NovoSeven Orphan Designation:
Treatment of bleeding episodes in hemophilia A or B patients with
inhibitors to Factor VIII or Factor IX.
Designation
6/6/1988 Sponsor and Address
Marketing Exclusivity Novo Nordisk, Inc.
3/25/1999 100 Overlook Center
Suite 200
Princeton NJ 08540-7810
***************************************************************************************
Generic Name Approved Orphan Indication:
cobiprostone

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis

Designation
11/14/2002 Sponsor and Address
Marketing Exclusivity Sucampo Pharmaceuticals, Inc.
4520 East-West Highway
Third Floor
Bethesda MD 20814
***************************************************************************************
Generic Name Approved Orphan Indication:
Coenzyme Q10

Trade Name:
Orphan Designation:
Treatment of Huntington's disease

Designation
3/5/2001 Sponsor and Address
Marketing Exclusivity Integrative Therapeutics, Inc.
825 Challenger Drive
Green Bay WI 54311

***************************************************************************************
Generic Name Approved Orphan Indication:
colchicine

Trade Name:
Orphan Designation:
Treatment of familial Mediterranean fever

Designation
9/25/2007 Sponsor and Address
Marketing Exclusivity AR Scientific, Inc.
1100 Orthodox Street
Philadelphia PA 19124

***************************************************************************************
Generic Name Approved Orphan Indication:
colchicine

Trade Name:
Orphan Designation:
For the treatment of Behcet's Syndrome.

Designation
9/25/2007 Sponsor and Address
Marketing Exclusivity AR Scientific, Inc.
1100 Orthodox Street
Philadelphia PA 19124

***************************************************************************************
Generic Name Approved Orphan Indication:
Colchicine

Trade Name:
Orphan Designation:
For arresting the progression of neurologic disability caused by
chronic progressive multiple sclerosis.
Designation
12/9/1985 Sponsor and Address
Marketing Exclusivity Pharmacontrol Corporation
661 Palisade Ave., P.O. Box 931
Englewood Cliffs NJ 07632

***************************************************************************************
Generic Name Approved Orphan Indication:
Colfosceril palmitate, cetyl alcohol, tyloxapol

Trade Name:
Exosurf Neonatal for Intratracheal Suspension Orphan Designation:
Treatment of established hyaline membrane disease at all
gestational ages.
Designation
10/20/1989 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Inc.
8/2/1990 5 Moore Drive
Research Triangle Park NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Colfosceril palmitate, cetyl alcohol, tyloxapol

Trade Name:
Exosurf Neonatal for Intratracheal Suspension Orphan Designation:
Prevention of hyaline membrane disease, also known as respiratory
distress syndrome, in infants born at 32 weeks gestation or less.
Designation
10/20/1989 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Inc.
8/2/1990 5 Moore Drive
Research Triangle Park NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Colfosceril palmitate, cetyl alcohol, tyloxapol

Trade Name:
Exosurf Orphan Designation:
Treatment of adult respiratory distress syndrome.

Designation
1/11/1993 Sponsor and Address
Marketing Exclusivity GlaxoSmithKline
5 Moore Drive
P.O. Box 13398
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Collagenase (lyophilized) for injection

Trade Name:
Plaquase Orphan Designation:
Treatment of Peyronie's disease.

Designation
3/12/1996 Sponsor and Address
Marketing Exclusivity Auxilium Pharmaceuticals, Inc.
40 Valley Stream Parkway
Malvern PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Combretastatin A4 phosphate

Trade Name:
Orphan Designation:
Treatment of ovarian cancer

Designation
5/8/2006 Sponsor and Address
Marketing Exclusivity OXiGENE, Inc.
230 Third Avenue
Waltham MA 02451

***************************************************************************************
Generic Name Approved Orphan Indication:
Combretastatin A4 Phosphate

Trade Name:
Orphan Designation:
Treatment of anaplastic thyroid cancer, medullary thyroid cancer,
and stage IV papillary or follicular thyroid cancer
Designation
7/23/2003 Sponsor and Address
Marketing Exclusivity OXiGENE, Inc
321 Arsenal Street
Watertown MA 02472

***************************************************************************************
Generic Name Approved Orphan Indication:
conjugate of human transferrin and a mutant
diphtheria toxin (CRM 107)

Trade Name:
TransMID Orphan Designation:
Treatment of malignant tumors of the central nervous system

Designation
12/3/2001 Sponsor and Address
Marketing Exclusivity Xenova Biomedix Limited
957 Budkingham Avenue
Slough

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
conjugated bile acids

Trade Name:
COBARTin Orphan Designation:
Treatment of steatorrhea in patients with short bowel syndrome

Designation
7/18/2003 Sponsor and Address
Marketing Exclusivity Jarrow Formulas, Inc.
1824 S. Robertson Blvd.
Los Angeles CA 90035-4317

***************************************************************************************
Generic Name Approved Orphan Indication:
Contulakin-G

Trade Name:
Orphan Designation:
Intrathecal treatment of neuropathic pain associated with spinal cord
injury
Designation
7/7/2005 Sponsor and Address
Marketing Exclusivity Cognetix, Inc.
421 Wakara Way
Salt Lake City UT 84108

***************************************************************************************
Generic Name Approved Orphan Indication:
Cordycepin

Trade Name:
Orphan Designation:
Treatment of TdT-positive acute lymphocytic leukemia

Designation
7/5/2007 Sponsor and Address
Marketing Exclusivity OncoVista, Inc.
14785 Omicron Drive
San Antonio TX 78245

***************************************************************************************
Generic Name Approved Orphan Indication:
Corticorelin ovine triflutate To differentiate between pituitary and ectopic production of ACTH in
patients with ACTH-dependent Cushing's syndrome.

Trade Name:
Acthrel Orphan Designation:
For use in differentiating pituitary and ectopic production of ACTH in
patients with ACTH-dependent Cushings syndrome.
Designation
11/24/1989 Sponsor and Address
Marketing Exclusivity Ferring Laboratories, Inc.
5/23/1996 400 Rella Boulevard, Suite 201
Suffern NY 10901

***************************************************************************************
Generic Name Approved Orphan Indication:
Corticotropin-releasing factor, human

Trade Name:
Xerecept Orphan Designation:
Treatment of peritumoral brain edema.

Designation
4/6/1998 Sponsor and Address
Marketing Exclusivity Neurobiological Technologies, Inc.
1387 Marina Way South
Richmond CA 94804

***************************************************************************************
Generic Name Approved Orphan Indication:
Coumarin

Trade Name:
Onkolox Orphan Designation:
Treatment of renal cell carcinoma.

Designation
12/22/1994 Sponsor and Address
Marketing Exclusivity Drossapharm LTD
4002 Basel

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
Coxsackievirus A21

Trade Name:
Cavatak Orphan Designation:
Treatment of stage II (T4), stage III, and stage IV melanoma

Designation
12/15/2005 Sponsor and Address
Marketing Exclusivity Viralytics Limited
Level 1, 82 Waterloo Road
North Ryde NSW, 2113

AUSTRALIA
***************************************************************************************
Generic Name Approved Orphan Indication:
Creatine

Trade Name:
Creapure Orphan Designation:
Treatment of Huntington's disease

Designation
10/11/2005 Sponsor and Address
Marketing Exclusivity Avicena Group, Inc.
228 Hamilton Avenue
Palo Alto CA 94301

***************************************************************************************
Generic Name Approved Orphan Indication:
creatine

Trade Name:
Creapure Orphan Designation:
Treatment of amyotrophic lateral sclerosis

Designation
2/12/2002 Sponsor and Address
Marketing Exclusivity Avicena Group, Inc.
580 California St.
Suite 1600
San Francisco CA 94104
***************************************************************************************
Generic Name Approved Orphan Indication:
Cromolyn sodium

Trade Name:
Gastrocrom Orphan Designation:
Treatment of mastocytosis.

Designation
3/8/1984 Sponsor and Address
Marketing Exclusivity Fisons Corporation
12/22/1989 755 Jefferson Rd
P.O. Box 1710
Rochester NY 14603
***************************************************************************************
Generic Name Approved Orphan Indication:
Cromolyn sodium 4% ophthalmic solution

Trade Name:
Opticrom 4% ophthalmic solution Orphan Designation:
Treatment of vernal keratoconjunctivitis.

Designation
7/24/1985 Sponsor and Address
Marketing Exclusivity Fisons Corporation
10/3/1984 755 Jefferson Rd.
P.O. Box 1710
Rochester NY 14603
***************************************************************************************
Generic Name Approved Orphan Indication:
Cryptosporidium hyperimmune bovine colostrum IgG
concentrate

Trade Name:
Orphan Designation:
Treatment of diarrhea in AIDS patients caused by infection with
Cryptosporidium parvum.
Designation
12/30/1991 Sponsor and Address
Marketing Exclusivity ImmuCell Corporation
56 Evergreen Drive
Portland ME 04103

***************************************************************************************
Generic Name Approved Orphan Indication:
cultured, partially T-Cell depleted, allogenic thymic
tissue for transplantation

Trade Name:
Orphan Designation:
As a therapy for primary immune deficiency resulting from athymia
associated with complete DiGeorge Syndrome
Designation
8/15/2003 Sponsor and Address
Marketing Exclusivity Duke University Medical Center
Division of Pediatric Allergy & Immunology
Erwin Road
Durham NC 27710
***************************************************************************************
Generic Name Approved Orphan Indication:
CY-1503

Trade Name:
Cylexin Orphan Designation:
Treatment of neonates and infants undergoing cardiopulmonary
bypass during surgical repair of congenital heart lesions.
Designation
7/18/1997 Sponsor and Address
Marketing Exclusivity Cytel Corporation
3525 John Hopkins Court
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
CY-1503

Trade Name:
Cylexin Orphan Designation:
Treatment of post-ischemic pulmonary reperfusion edema following
surgical treatment for chronic thromboembolic pulmonary
Designation hypertension.
12/22/1993 Sponsor and Address
Marketing Exclusivity Cytel Corporation
3525 John Hopkins Court
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
CY-1899

Trade Name:
Orphan Designation:
Treatment of chronic active hepatitis B infection in HLA-A2 positive
patients.
Designation
3/16/1994 Sponsor and Address
Marketing Exclusivity Cytel Corporation
3525 John Hopkins Court
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
Cyclo {{(E,Z)-(2S,3R,4R)-3-hydroxy-4-methyl-2-
(methylamino)nona-6,8-dienoyl}-L-2-aminobytyrl-N-
methyl-glycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-
leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-
L-leucyl-N-methyl-L-valyl}

Trade Name:
Orphan Designation:
Treatment and chronic control of non-infectious posterior,
intermediate and pan-uveitis
Designation
12/20/2006 Sponsor and Address
Marketing Exclusivity Lux Biosciences, Inc.
Hoarborside Financial Center
Plaza 10, 14th Floor
Jersey City NJ 07302
***************************************************************************************
Generic Name Approved Orphan Indication:
cyclosporin Kristin Miller, CSO, HFD-590.

Trade Name:
Orphan Designation:
Prophylaxis of organ rejection in patients receiving allogeneic lung
transplant
Designation
11/25/2003 Sponsor and Address
Marketing Exclusivity APT Pharmaceuticals, Inc.
950 Tower Lane
Suite 790
Foster City CA 94404
***************************************************************************************
Generic Name Approved Orphan Indication:
Cyclosporin A

Trade Name:
Cyclosporin Orphan Designation:
Treatment of amyotrophic lateral sclerosis and its variants

Designation
10/29/2004 Sponsor and Address
Marketing Exclusivity Maas BiolAB
Tecnology Ventures Corporation Technopolis
1155 University Blvd., SE
Albuquerque NM 87106
***************************************************************************************
Generic Name Approved Orphan Indication:
cyclosporine

Trade Name:
Pluminiq Orphan Designation:
Treatment of acute rejection in patients requiring allogenic lung
transplants.
Designation
11/25/2003 Sponsor and Address
Marketing Exclusivity APT Pharmaceuticals, Inc.
950 Tower Lane
Suite 790
Foster City CA 94404
***************************************************************************************
Generic Name Approved Orphan Indication:
Cyclosporine 2% ophthalmic ointment

Trade Name:
Orphan Designation:
Treatment of patients at high risk of graft rejection following
penetrating keratoplasty.
Designation
8/1/1991 Sponsor and Address
Marketing Exclusivity Allergan, Inc.
2525 Dupont Drive
P.O. Box 19534
Irvine CA 92623-9534
***************************************************************************************
Generic Name Approved Orphan Indication:
Cyclosporine 2% ophthalmic ointment

Trade Name:
Orphan Designation:
For use in corneal melting syndromes of known or presumed
immunologic etiopathogenesis, including Mooren's ulcer.
Designation
8/1/1991 Sponsor and Address
Marketing Exclusivity Allergan, Inc.
2525 Dupont Drive
P.O. Box 19534
Irvine CA 92623-9534
***************************************************************************************
Generic Name Approved Orphan Indication:
cyclosporine A

Trade Name:
Orphan Designation:
Treatment of vernal keratoconjunctivitis

Designation
5/4/2007 Sponsor and Address
Marketing Exclusivity NOVAGALI Pharma SA
Batiment Genavenir IV
F-91058-Evry cedex

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
Cyclosporine A implant

Trade Name:
Orphan Designation:
For the prevention of acute rejection in cornea transplant patients

Designation
1/8/2007 Sponsor and Address
Marketing Exclusivity Lux Biosciences, Inc.
Harborside Financial Center
Plaza 10, 14th Floor
Jersey City NJ 07302
***************************************************************************************
Generic Name Approved Orphan Indication:
Cyclosporine in combination with omega-3
polyunsaturated fatty acids

Trade Name:
Orphan Designation:
Prevention of solid organ graft rejection.

Designation
12/6/2000 Sponsor and Address
Marketing Exclusivity RTP Pharma Corporation
200 Westpark Corporate Center
4364 South Alston Avenue
Durham NC 27713-2280
***************************************************************************************
Generic Name Approved Orphan Indication:
Cyclosporine ophthalmic

Trade Name:
Optimmune Orphan Designation:
Treatment of severe keratoconjunctivitis sicca associated with
Sjogren's syndrome.
Designation
11/9/1988 Sponsor and Address
Marketing Exclusivity University Of Georgia
College Of Veterinary Medicine
Department of Small Animal Medicine
Athens GA 30602
***************************************************************************************
Generic Name Approved Orphan Indication:
Cyproterone acetate

Trade Name:
Androcur Orphan Designation:
Treatment of severe hirsutism.

Designation
10/26/1984 Sponsor and Address
Marketing Exclusivity Berlex Laboratories, Inc.
300 Fairfield Road
Wayne NJ 07470

***************************************************************************************
Generic Name Approved Orphan Indication:
Cysteamine

Trade Name:
Orphan Designation:
Treatment of nephropathic cystinosis.

Designation
5/1/1986 Sponsor and Address
Marketing Exclusivity Thoene, Jess G., M.D.
University of Michigan Medical School
300 NIB, 1192 SE
Ann Arbor MI 48109-0408
***************************************************************************************
Generic Name Approved Orphan Indication:
Cysteamine Treatment of nephropathic cystinosis in adults and children.

Trade Name:
Cystagon Orphan Designation:
Treatment of nephropathic cystinosis.

Designation
1/25/1991 Sponsor and Address
Marketing Exclusivity Mylan Laboratories, Inc.
8/15/1994 781 Chestnut Ridge Road
P.O. Box 4310
Morgantown WV 26504
***************************************************************************************
Generic Name Approved Orphan Indication:
Cysteamine hydrochloride

Trade Name:
Orphan Designation:
Treatment of corneal cystine crystal accumulation in cystinosis
patients.
Designation
8/19/1997 Sponsor and Address
Marketing Exclusivity Sigma-Tau Pharmaceuticals, Inc.
800 South Frederick Avenue
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Cystic fibrosis gene therapy

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis.

Designation
6/30/1992 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
One Mountain Rd.
P.O. Box 9322
Framingham MA 01701-9322
***************************************************************************************
Generic Name Approved Orphan Indication:
Cystic fibrosis Tr gene therapy (recombinant
adenovirus)
Trade Name:
AdGVCFTR.10 Orphan Designation:
Treatment of cystic fibrosis.

Designation
3/9/1995 Sponsor and Address
Marketing Exclusivity GenVec, Inc.
12111 Parklawn Drive
Rockville MD 20852

***************************************************************************************
Generic Name Approved Orphan Indication:
Cystic fibrosis transmembrane conductance regulator

Trade Name:
Orphan Designation:
For cystic fibrosis transmembrane conductance regulator protein
replacement therapy in cystic fibrosis patients.
Designation
1/14/1992 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
One Mountain Road
P.O. Box 9322
Framingham MA 01701-9322
***************************************************************************************
Generic Name Approved Orphan Indication:
Cystic fibrosis transmembrane conductance regulator
gene

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis.

Designation
1/8/1993 Sponsor and Address
Marketing Exclusivity Genetic Therapy, Inc.
938 Clopper Road
Gaithersburg MD 20878

***************************************************************************************
Generic Name Approved Orphan Indication:
Cytarabine liposomal Intrathecal treatment of lymphomatous meningitis.

Trade Name:
DepoCyt Orphan Designation:
Treatment of neoplastic meningitis.

Designation
6/2/1993 Sponsor and Address
Marketing Exclusivity Pacira Pharmaceuticals, Inc.
4/1/1999 10450 Science Center Drive
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
cytarabine liposome

Trade Name:
DepoCyt Orphan Designation:
Treatment of gliomas

Designation
1/30/2007 Sponsor and Address
Marketing Exclusivity Bruce Frankel, MD
Medical University of South Carolina
96 Jonathan Lucas Street, Suite 428 CSB
Charleston SC 29425
***************************************************************************************
Generic Name Approved Orphan Indication:
Cytomegalovirus DNA Vaccine
w/Copolymer/Benzalkonium Chloride

Trade Name:
Orphan Designation:
For use in prevention of clinically significant CMV viremia, CMV
disease and associated complications in at-risk hematopoietic cell
Designation transplant and solid organ transplant populations
9/23/2006 Sponsor and Address
Marketing Exclusivity Vical Inc.
10390 Pacific Center Court
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
Cytomegalovirus DNA vaccine with plasmids
expressing pp65 and gB genes

Trade Name:
Orphan Designation:
Prevention of clinically significant cytomegalovirus (CMV) viremia,
CMV disease and asociated complications in at-risk hematopoietic
Designation cell transplant and solid transplant populations
6/3/2005 Sponsor and Address
Marketing Exclusivity Vical Incorporated
10390 Pacific Center Court
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
Cytomegalovirus immune globulin (human) #1) Attenuation of primary CMV disease associated with kidney
transplant recipients who are seronegative for CMV and who receive
a kidney from a CMV seropositve donor; #2) Prophylaxis of CMV
Trade Name: disease associated transplantation of kidney (all other), lung, liver,
CytoGam Orphan Designation:
Prevention or attenuation of primary cytomegalovirus disease in
immunosuppressed recipients of organ transplants.
Designation
8/3/1987 Sponsor and Address
Marketing Exclusivity Massachussetts Public Health Biologic Laboratories
12/4/1998 305 South Street
Boston MA 02130-3597

***************************************************************************************
Generic Name Approved Orphan Indication:
Cytomegalovirus immune globulin intravenous
(human)
Trade Name:
Orphan Designation:
For use in conjunction with ganciclovir sodium for the treatment of
cytomegalovirus pneumonia in bone marrow transplant patients.
Designation
1/28/1991 Sponsor and Address
Marketing Exclusivity Bayer Corporation
Pharmaceutical Division, Biological Products
400 Morgan Lane
New Haven CT 06516
***************************************************************************************
Generic Name Approved Orphan Indication:
Daclizumab Prophylaxis of acute organ rejection in patients receiving renal
transplants, to be used as a part of an immunosuppressive regimen
that includes cyclosporine and corticosteroids.
Trade Name:
Zenapax Orphan Designation:
Prevention of acute renal allograft rejection.

Designation
3/5/1993 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
12/10/1997 340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Dantrolene sodium

Trade Name:
Dantrium Orphan Designation:
Treatment of the neuroleptic malignant syndrome.

Designation
12/14/1987 Sponsor and Address
Marketing Exclusivity Norwich Eaton Pharmaceuticals
P.O. Box 191
Norwich NY 13815

***************************************************************************************
Generic Name Approved Orphan Indication:
Dapsone

Trade Name:
Orphan Designation:
Prophylaxis of toxoplasmosis in severely immunocompromised
patients with CD4 counts below 100.
Designation
11/7/1994 Sponsor and Address
Marketing Exclusivity Jacobus Pharmaceutical Company, Inc.
37 Cleveland Lane
P.O. Box 5290
Princeton NJ 08540
***************************************************************************************
Generic Name Approved Orphan Indication:
Dapsone USP

Trade Name:
Dapsone Orphan Designation:
For the combination treatment of Pneumocystis carinii pneumonia in
conjunction with trimethoprim.
Designation
1/8/1992 Sponsor and Address
Marketing Exclusivity Jacobus Pharmaceutical Company
37 Cleveland Lane
P.O. Box 5290
Princeton NJ 08540
***************************************************************************************
Generic Name Approved Orphan Indication:
Dapsone USP

Trade Name:
Dapsone Orphan Designation:
Prophylaxis for Pneumocystis carinii pneumonia.

Designation
12/24/1991 Sponsor and Address
Marketing Exclusivity Jacobus Pharmaceutical Company
37 Cleveland Lane
P.O. Box 5290
Princeton NJ 08540
***************************************************************************************
Generic Name Approved Orphan Indication:
Dasatinib Treatment of adults with Philadelphia chromosome-positive acute
lymphoblastic leukemia with resistance or intolerance to prior therapy

Trade Name:
Sprycel Orphan Designation:
Treatment of Philadelphia-positive acute lymphoblastic leukemia

Designation
11/18/2005 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Company
6/28/2006 5 Research Parkway
Wallingford CT 06492

***************************************************************************************
Generic Name Approved Orphan Indication:
Dasatinib Treatment of adults with chronic myeloid leukemia with resistance or
intolerance to prior therapy including imatinib

Trade Name:
Sprycel Orphan Designation:
Treatment of chronic myelogenous leukemia

Designation
11/28/2005 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Company
6/28/2006 5 Research Parkway
Wallingford CT 06492

***************************************************************************************
Generic Name Approved Orphan Indication:
Daunorubicin citrate liposome injection First line cytotoxic therapy for advanced, HIV related Kaposi's
sarcoma.

Trade Name:
DaunoXome Orphan Designation:
Treatment of patients with advanced HIV-associated Kaposi's
sarcoma.
Designation
5/14/1993 Sponsor and Address
Marketing Exclusivity NeXstar Pharmaceuticals, Inc.
4/8/1996 650 Cliffside Drive
San Dimas CA 91773

***************************************************************************************
Generic Name Approved Orphan Indication:
DEAE-rebeccamycin

Trade Name:
Orphan Designation:
Treatment of bile duct tumors

Designation
3/1/2004 Sponsor and Address
Marketing Exclusivity Helsinn Healthcare SA
Via Pian Scairolo, 6912 Pazzallo
Lugano

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
debrase

Trade Name:
Debridase Orphan Designation:
Debridement of acute, deep dermal burns in hospitalized patients

Designation
8/20/2003 Sponsor and Address
Marketing Exclusivity MediWound, Ltd.
3, Azrieli Center
Triangular Tower 45th Floor

ISRAEL
***************************************************************************************
Generic Name Approved Orphan Indication:
Decitabine

Trade Name:
Dacogen Orphan Designation:
Treatment of acute myeloid leukemia

Designation
8/4/2006 Sponsor and Address
Marketing Exclusivity MGI Pharma
6611 Tributary Street
Baltimore MD 21224-6515

***************************************************************************************
Generic Name Approved Orphan Indication:
decitabine

Trade Name:
Orphan Designation:
Treatment of sickle cell anemia

Designation
9/9/2002 Sponsor and Address
Marketing Exclusivity MGI CP, d/b/a MGI Pharma
6611 Tributary Street
Baltimore MD 21224

***************************************************************************************
Generic Name Approved Orphan Indication:
Decitabine

Trade Name:
Orphan Designation:
Treatment of chronic myelogenous leukemia.

Designation
3/8/1999 Sponsor and Address
Marketing Exclusivity MGI CP, Inc. d/b/a MGI Pharma
6611 Tributary Street
Suite 200
Baltimore MD 21224
***************************************************************************************
Generic Name Approved Orphan Indication:
Decitabine for treatment of patients with myelodysplastic syndromes (MDS)
including previously treated and untreated, de novo and secondary
MDS of all French-American-British subtypes (refractory anemia,
Trade Name: refractory anemia with ringed sideroblasts, refractory anemia with
excess blasts, refractory anemia with excess blasts in transformation,
and chronic myelomonocytic leukemia) and intermediate-1,
intermediate-2, and high-risk International Prognostic Scoring System
Dacogen Orphan Designation:
Treatment of myelodysplastic syndromes.

Designation
3/8/1999 Sponsor and Address
Marketing Exclusivity MGI CP, Inc. d/b/a MGI Pharma
5/2/2006 6611 Tributary Street
Suite 200
Baltimore MD 21224
***************************************************************************************
Generic Name Approved Orphan Indication:
Deferasirox Treatment of chronic iron overload due to blood transfusions
(transfusional hemosiderosis) in patients 2 years of age or older

Trade Name:
Exjade Orphan Designation:
Treatment of chronic iron overload in patients with transfusion-
dependent anemias
Designation
11/21/2002 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
11/2/2005 59 Route 10
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
deferiprone

Trade Name:
Ferriprox Orphan Designation:
Treatment of iron overload in patients with hematologic disorders
requiring chronic transfusion therapy
Designation
12/12/2001 Sponsor and Address
Marketing Exclusivity ApoPharma, Inc. A Division of
Apotex Research Inc.
Toronto, Canada M9L 1T9

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
deferoxamine-starch conjugate

Trade Name:
Orphan Designation:
Treatment of acute iron poisoning.

Designation
1/28/2005 Sponsor and Address
Marketing Exclusivity Biomedical Frontiers, Inc.
1095 10th Avenue, SE
Minneapolis MN 55414

***************************************************************************************
Generic Name Approved Orphan Indication:
defibrotide

Trade Name:
Orphan Designation:
For the prevention of hepatic veno-occlusive disease.

Designation
1/8/2007 Sponsor and Address
Marketing Exclusivity Gentium SpA
Piazza XX Settembre, 2

ITALY
***************************************************************************************
Generic Name Approved Orphan Indication:
Defibrotide

Trade Name:
Orphan Designation:
For the treatment of hepatic veno-occlusive disease

Designation
5/21/2003 Sponsor and Address
Marketing Exclusivity Gentium SpA
Piazza XX Settembre, 2
22079 Villa Guardia (CO)

ITALY
***************************************************************************************
Generic Name Approved Orphan Indication:
Defibrotide

Trade Name:
Orphan Designation:
Treatment of thrombotic thrombocytopenic purpura.

Designation
7/5/1985 Sponsor and Address
Marketing Exclusivity Crinos International
Via Belvedere 1
Villa Guardia, Italy 22079

***************************************************************************************
Generic Name Approved Orphan Indication:
Dehydroepiandrosterone

Trade Name:
Orphan Designation:
Treatment of systemic lupus erythematosus (SLE) and the reduction
in the use of steroids in steroid-dependent SLE patients.
Designation
7/13/1994 Sponsor and Address
Marketing Exclusivity Genelabs Technologies, Inc.
505 Penobscot Drive
Redwood City CA 94063

***************************************************************************************
Generic Name Approved Orphan Indication:
Dehydroepiandrosterone (DHEA)

Trade Name:
Fidelin Orphan Designation:
Replacement therapy in individuals with adrenal insufficiency

Designation
8/19/2003 Sponsor and Address
Marketing Exclusivity Paladin Labs, Inc.
6111 Royalmount Avenue, Suite 102
Montreal
Quebec H4P 2T4
CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Dehydroepiandrosterone sulfate sodium

Trade Name:
Orphan Designation:
Treatment of serious burns requiring hospitalization.

Designation
1/29/1997 Sponsor and Address
Marketing Exclusivity Pharmadigm, Inc.
2401 Foothill Drive
Salt Lake City UT 84109-1405

***************************************************************************************
Generic Name Approved Orphan Indication:
Dehydroepiandrosterone sulfate sodium

Trade Name:
Orphan Designation:
To accelerate the re-epithelialization of donor sites in those
hospitalized burn patients who must undergo autologous skin
Designation grafting.
1/28/1997 Sponsor and Address
Marketing Exclusivity Pharmadigm, Inc.
2401 Foothill Drive
Salt Lake City UT 84109-1405

***************************************************************************************
Generic Name Approved Orphan Indication:
Denileukin diftitox Treatment of patients with persistent or recurrent cutaneous T-cell
lymphoma whose malignant cells express the CD25 component of
the IL-2 receptor.
Trade Name:
Ontak Orphan Designation:
Treatment of patients with Cutaneous T-cell Lymphoma.

Designation
8/21/1996 Sponsor and Address
Marketing Exclusivity Eisai Medical Research, Inc.
2/5/1999 55 Challenger Road
Ridgefield Park NJ 07660

***************************************************************************************
Generic Name Approved Orphan Indication:
Deslorelin

Trade Name:
Somagard Orphan Designation:

Designation
11/5/1987 Sponsor and Address
Marketing Exclusivity Roberts Pharmaceutical Corp.
Meridian Center II
Four Industrial Way West
Eatontown NJ 07724-2274
***************************************************************************************
Generic Name Approved Orphan Indication:
Desmoglein 3 synthetic peptide (PI-0824)

Trade Name:
Orphan Designation:
Treatment of pemphigus vulgaris

Designation
10/26/2004 Sponsor and Address
Marketing Exclusivity Peptimmune, Inc.
64 Sidney Street
Cambridge MA 02139-4170

***************************************************************************************
Generic Name Approved Orphan Indication:
Desmopressin acetate Treatment of patients with hemophilia A or von Willebrand's disease
(type I) whose factor VIII coagulant activity level is greater than 5%.

Trade Name:
Orphan Designation:
Treatment of mild hemophilia A and von Willebrand's disease.

Designation
1/22/1991 Sponsor and Address
Marketing Exclusivity Aventis Behring L.L.C.
3/7/1994 1020 First Avenue
PO Box 61501
King of Prussia PA 19406-0901
***************************************************************************************
Generic Name Approved Orphan Indication:
Dexamethasone

Trade Name:
Posurdex Orphan Designation:
For use in posterior segment drug delivery system in the treatment of
idiopathic intermediate uveitis.
Designation
9/11/1998 Sponsor and Address
Marketing Exclusivity Allergan
2525 Dupont Drive
P. O. Box 19534
Irvine CA 92623-9534
***************************************************************************************
Generic Name Approved Orphan Indication:
dexanabinol

Trade Name:
Orphan Designation:
For the attenuation or amelioration of the long-term neurological
sequelae associated with moderate and severe traumatic brain injury
Designation
8/11/2004 Sponsor and Address
Marketing Exclusivity Pharmos Corporation
99 Wood Avenue
Suite 311
Iselin NJ 08830
***************************************************************************************
Generic Name Approved Orphan Indication:
dexrazoxane Treatment of extravasation resulting from IV anthracycline
chemotherapy

Trade Name:
Totect Orphan Designation:
Treatment of anthracycline extravasation during chemotherapy

Designation
3/25/2004 Sponsor and Address
Marketing Exclusivity Topo Target A/S
9/6/2007 Fruebjergvej 3, 2100
Copenhagen

DENMARK
***************************************************************************************
Generic Name Approved Orphan Indication:
Dexrazoxane Cardiomyopathy associated with doxorubicin administration in
women with metastatic breast cancer who have received a
cumulative dose of 300mg/m2.
Trade Name:
Zinecard Orphan Designation:
For the prevention of cardiomyopathy associated with doxorubicin
administration.
Designation
12/17/1991 Sponsor and Address
Marketing Exclusivity Pharmacia & Upjohn
5/26/1995 7000 Portage Road
Kalamazoo MI 49001-0199

***************************************************************************************
Generic Name Approved Orphan Indication:
dextran 1

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis

Designation
3/21/2003 Sponsor and Address
Marketing Exclusivity BCY LifeSciences Inc.
160 Eglinton Ave. East
Suite 600
Toronto, Ontario M4P 3B
CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Dextran 70

Trade Name:
Dehydrex Orphan Designation:
Treatment of recurrent corneal erosion unresponsive to conventional
therapy.
Designation
3/5/1990 Sponsor and Address
Marketing Exclusivity Holles Laboratories, Inc.
30 Forest Notch
Cohasset MA 02025

***************************************************************************************
Generic Name Approved Orphan Indication:
Dextran and deferoxamine

Trade Name:
Bio-Rescue Orphan Designation:
Treatment of acute iron poisoning.

Designation
3/8/1991 Sponsor and Address
Marketing Exclusivity Biomedical Frontiers, Inc.
1095 10th Avenue S.E.
Minneapolis MN 55414

***************************************************************************************
Generic Name Approved Orphan Indication:
Dextran sulfate (inhaled, aerosolized)

Trade Name:
Uendex Orphan Designation:
For use as an adjunct to the treatment of cystic fibrosis.

Designation
10/5/1990 Sponsor and Address
Marketing Exclusivity Kennedy & Hoidal, M.D.'s
University Of Utah Medical Center
50 North Medical Drive, Room 4R240
Salt Lake City UT 84132
***************************************************************************************
Generic Name Approved Orphan Indication:
Dextran sulfate sodium

Trade Name:
Orphan Designation:
Treatment of aquired immunodeficiency syndrome.

Designation
11/19/1987 Sponsor and Address
Marketing Exclusivity Ueno Fine Chemicals Industry, Ltd.
2-31 Koraibashi, Higashi-ku
Osaka 541

JAPAN
***************************************************************************************
Generic Name Approved Orphan Indication:
DHA-paclitaxel

Trade Name:
Taxoprexin Orphan Designation:
Treatment of pancreatic cancer

Designation
9/25/2001 Sponsor and Address
Marketing Exclusivity Luitpold Pharmaceuticals, Inc..
1000 Madison Ave.
Norristown PA 19403

***************************************************************************************
Generic Name Approved Orphan Indication:
DHA-paclitaxel

Trade Name:
Taxoprexin Orphan Designation:
Treatment of adenocarcinoma of the stomach or lower esophagus

Designation
5/1/2003 Sponsor and Address
Marketing Exclusivity Luitpold Pharmaceuticals, Inc.
1000 Madison Ave.
Norristown PA 19403

***************************************************************************************
Generic Name Approved Orphan Indication:
DHA-paclitaxel

Trade Name:
Taxoprexin Orphan Designation:
Treatment of metastatic malignant melanoma

Designation
10/10/2002 Sponsor and Address
Marketing Exclusivity Luitpold Pharmaceuticals, Inc..
1000 Madison Ave.
Norristown PA 19403

***************************************************************************************
Generic Name Approved Orphan Indication:
Dianeal peritoneal dialysis solution with 1.1% amino
acids
Trade Name:
Nutrineal (Peritoneal Dialysis Solution with 1.1% Orphan Designation:
Amino Acid For use as a nutritional supplement for the treatment of
malnourishment in patients undergoing continuous ambulatory
Designation peritoneal dialysis.
6/11/1992 Sponsor and Address
Marketing Exclusivity Baxter Healthcare Corporation
1620 Waukegan Road
McGaw Park IL 60085

***************************************************************************************
Generic Name Approved Orphan Indication:
Diazepam viscous solution for rectal administration

Trade Name:
Orphan Designation:
For the management of selected, refractory, patients with epilepsy,
on stable regimens of antiepileptic drugs (AEDs), who require
Designation intermittent use of diazepam to control bouts of increased seizure
2/25/1992 Sponsor and Address activity.
Marketing Exclusivity Valeant Pharmaceuticals
7/29/1997 3300 Hyland Avenue
Costa Mesa CA 92626

***************************************************************************************
Generic Name Approved Orphan Indication:
Diaziquone

Trade Name:
Orphan Designation:
Treatment of primary brain malignancies (grade III and IV
astrocytomas).
Designation
11/10/1983 Sponsor and Address
Marketing Exclusivity Warner-Lambert Company
2800 Plymouth Rd., P.O. Box 1047
Ann Arbor MI 48106

***************************************************************************************
Generic Name Approved Orphan Indication:
Dideoxyinosine

Trade Name:
Orphan Designation:
Treatment of acquired immunodeficiency syndrome.

Designation
6/22/1988 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb
2400 West Lloyd Expressway
Evansville IN 47721

***************************************************************************************
Generic Name Approved Orphan Indication:
Diethyldithiocarbamate

Trade Name:
Imuthiol Orphan Designation:
Treatment of AIDS.

Designation
4/3/1986 Sponsor and Address
Marketing Exclusivity Connaught Laboratories
Route 611, P.O. Box 187
Swiftwater PA 18370

***************************************************************************************
Generic Name Approved Orphan Indication:
diethylenetriaminepentaacetate (DPTA)

Trade Name:
Orphan Designation:
For treatment of patients with known or suspected internal
contamination with plutonium, americium or curium to increase the
Designation rates of elimination.
4/14/2004 Sponsor and Address
Marketing Exclusivity CIS-US
10 DeAngelo Drive
Bedford MA 01730

***************************************************************************************
Generic Name Approved Orphan Indication:
Diethylenetriaminepentaacetic acid (DTPA) Treatment of internal contamination with plutonium, americium or
curium

Trade Name:
Orphan Designation:
Treatment of patients with known or suspected internal contamination
with plutonium, americium, or curium to increase the rates of
Designation elimination.
4/28/2004 Sponsor and Address
Marketing Exclusivity Hameln Pharmaceuticals gmbh
8/11/2004 Langes Feld 13
Hameln

GERMANY
***************************************************************************************
Generic Name Approved Orphan Indication:
Diethylnorspermine (DENSPM)

Trade Name:
Orphan Designation:
Treatment for hepatocellular carcinoma

Designation
5/25/2004 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
153 Second Avenue
Waltham MA 02451

***************************************************************************************
Generic Name Approved Orphan Indication:
diferuloylmethane

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis

Designation
6/13/2003 Sponsor and Address
Marketing Exclusivity Allertein Therapeutics, LLC
640 Sasco Hill Road
Fairfield CT 06824

***************************************************************************************
Generic Name Approved Orphan Indication:
Digitoxin

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis

Designation
5/27/2005 Sponsor and Address
Marketing Exclusivity Bette S. Pollard, LLC
11008 Lamplighter Lane
Potomac MD 20854

***************************************************************************************
Generic Name Approved Orphan Indication:
digitoxin

Trade Name:
Orphan Designation:
Treatment of soft tissue sarcomas

Designation
10/18/2001 Sponsor and Address
Marketing Exclusivity PrimeCyte, Inc.
130 Fifth Ave., N.
Seattle WA 98109-4933

***************************************************************************************
Generic Name Approved Orphan Indication:
digitoxin

Trade Name:
Orphan Designation:
Treatment of ovarian cancer

Designation
11/2/2001 Sponsor and Address
Marketing Exclusivity PrimeCyte, Inc.
130 Fifth Ave., N.
Seattle WA 98109-4933

***************************************************************************************
Generic Name Approved Orphan Indication:
Digoxin immune FAB (Ovine)

Trade Name:
Digibind Orphan Designation:
Treatment of potentially life threatening digitalis intoxication in
patients who are refractory to management by conventional therapy.
Designation
11/1/1984 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Inc.
4/22/1986 5 Moore Drive
Research Triangle Park NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Digoxin immune fab(ovine)

Trade Name:
Digidote Orphan Designation:
Treatment of life-threatening acute cardiac glycoside intoxication
manifested by conduction disorders, ectopic ventricular activity and
Designation (in some cases) hyperkalemia.
3/11/1985 Sponsor and Address
Marketing Exclusivity Boehringer Mannheim Corp.
1301 Piccard Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
dihydroartemisinin and piperaquine

Trade Name:
Eurartesim Orphan Designation:
Treatment of uncomplicated malaria caused by "Plasmodium
falciparum," Plasmodium vivax," Plasmodium malariae," or
Designation "Plasmodium ovale."
1/8/2007 Sponsor and Address
Marketing Exclusivity Sigma-Tau Pharmaceuticals, Inc.
800 South Frederick Avenue
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Dihydrotestosterone

Trade Name:
Androgel -DHT Orphan Designation:
Treatment of weight loss in AIDS patients with HIV-associated wasting.

Designation
2/5/1996 Sponsor and Address
Marketing Exclusivity Besins Internaitonal, US Inc.
610 Herndon Parkway
Suite 750
Herndon VA 20170
***************************************************************************************
Generic Name Approved Orphan Indication:
Dimethyl sulfoxide

Trade Name:
Orphan Designation:
Treatment of increased intracranial pressure in patients with severe,
closed-head injury, also known as traumatic brain coma, for whom no
Designation other effective treatment is available.
11/22/1994 Sponsor and Address
Marketing Exclusivity Pharma 21
c/o Univ. of Calif., San Diego
9500 Gilman Dr.
La Jolla CA 92093-0624
***************************************************************************************
Generic Name Approved Orphan Indication:
Dimethyl sulfoxide

Trade Name:
Orphan Designation:
Treatment of cutaneous manifestations of scleroderma.

Designation
6/6/1986 Sponsor and Address
Marketing Exclusivity Research Industries Corp.

***************************************************************************************
Generic Name Approved Orphan Indication:
Dimethylsulfoxide

Trade Name:
Orphan Designation:
Treatment of palmar-plantar erythrodysethesia syndrome.

Designation
4/6/1998 Sponsor and Address
Marketing Exclusivity Cancer Technologies, Inc.
7301 East 22nd Street
Suite 10E
Tucson AZ 85710
***************************************************************************************
Generic Name Approved Orphan Indication:
Dimethylsulfoxide

Trade Name:
Orphan Designation:
Topical treatment for the prevention of soft tissue injury following
extravastion of cytotoxic drugs.
Designation
4/15/1997 Sponsor and Address
Marketing Exclusivity Cancer Technologies, Inc.
7301 East 22nd Street
Suite 10E
Tucson AZ 85710
***************************************************************************************
Generic Name Approved Orphan Indication:
Dipalmitoylphosphatidylcholine
/phosphatidylglycerol
Trade Name:
ALEC Orphan Designation:
Prevention and treatment of neonatal respiratory distress syndrome.

Designation
7/28/1988 Sponsor and Address
Marketing Exclusivity Forum Products, Inc.
33 Flying Point Road
Southampton NY 11968

***************************************************************************************
Generic Name Approved Orphan Indication:
diphenylcyclopenone

Trade Name:
Orphan Designation:
Treatment of chronic severe forms of alopecia areata (Alopecia
Totalis [AT]/Alopecia Universalis [AU])
Designation
6/13/2003 Sponsor and Address
Marketing Exclusivity Lloyd E. King, Jr.
1900 Patterson Street
Suite 104
Nashville TN 37203
***************************************************************************************
Generic Name Approved Orphan Indication:
Disaccharide tripeptide glycerol dipalmitoyl

Trade Name:
Immther Orphan Designation:
Treatment of pulmonary and hepatic metastases in patients with
colorectal adenocarcinoma.
Designation
3/1/1990 Sponsor and Address
Marketing Exclusivity ImmunoTherapeutics, Inc.
3505 Riverview Circle
Moorhead MN 56560

***************************************************************************************
Generic Name Approved Orphan Indication:
Disodium clodronate

Trade Name:
Orphan Designation:
Treatment of hypercalcemia of malignancy.

Designation
6/16/1993 Sponsor and Address
Marketing Exclusivity Discovery Experimental & Development, Inc.
29949 S.R. 54 West
Wesley Chapel FL 33543

***************************************************************************************
Generic Name Approved Orphan Indication:
Disodium clodronate tetrahydrate

Trade Name:
Bonefos Orphan Designation:
Treatment of increased bone resorption due to malignancy.

Designation
3/5/1990 Sponsor and Address
Marketing Exclusivity Anthra Pharmaceuticals, Inc.
103 Carnegie Center, Suite 102
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Disodium silibinin dihemisuccinate

Trade Name:
Legalon Orphan Designation:
Treatment of hepatic intoxication by Amanita phalloides (mushroom
poisoning).
Designation
7/10/1986 Sponsor and Address
Marketing Exclusivity Pharmaquest Corporation
4470 Redwood Highway
San Rafael CA 94903

***************************************************************************************
Generic Name Approved Orphan Indication:
DMP 777

Trade Name:
Orphan Designation:
Therapeutic management of patients with lung disease attributable
to cystic fibrosis.
Designation
6/4/1996 Sponsor and Address
Marketing Exclusivity DuPont Pharmaceuticals Company
Chestnut Run, Maple Run
Centre Rd.
Wilmington DE 19805
***************************************************************************************
Generic Name Approved Orphan Indication:
DNA plasmid vector expressing human IL-12 gene

Trade Name:
Orphan Designation:
Treatment of ovarian cancer.

Designation
4/4/2005 Sponsor and Address
Marketing Exclusivity Expression Genetics, Inc.
2215 Mock Road
Huntsville AL 35801

***************************************************************************************
Generic Name Approved Orphan Indication:
DNA-lipid complex (DMRIE/DOPE)/plasmid vector
(VCL-1102, Vical) expressing human interleukin-2

Trade Name:
Leuvectin Orphan Designation:
Treatment of renal cell carcinoma.

Designation
4/28/2000 Sponsor and Address
Marketing Exclusivity Vical Incorporated
9373 Towne Center Dr.
Suite 100
San Diego CA 92121-3088
***************************************************************************************
Generic Name Approved Orphan Indication:
DNP-Modified autologous tumor vaccine

Trade Name:
O-Vax Orphan Designation:
Adjuvant therapy for the treatment of ovarian cancer

Designation
9/21/2000 Sponsor and Address
Marketing Exclusivity AVAX Technologies, Inc.
9200 Indian Creek Parkway
Building 9, Suite 200
Overland Park KS 66210
***************************************************************************************
Generic Name Approved Orphan Indication:
docosahexanoic acid-paclitaxel

Trade Name:
Taxoprexin Orphan Designation:
Treatment of hormone-refractory prostate cancer.

Designation
3/5/2001 Sponsor and Address
Marketing Exclusivity Luitpold Pharmaceuticals, Inc.
1000 Madison Ave
Norristown PA 19403

***************************************************************************************
Generic Name Approved Orphan Indication:
Doripenem

Trade Name:
Orphan Designation:
Treatment of bronchopulmonary infection in patients with cystic
fibrosis who are colonized with Pseudomonas aeruginosa or
Designation Burkholderia cepacia.
7/16/2004 Sponsor and Address
Marketing Exclusivity Johnson & Johnson Pharmaceutical Research & Dev.
920 US Highway 202
P. O. Box 300
Raritan NJ 08869
***************************************************************************************
Generic Name Approved Orphan Indication:
Dornase alfa In conjunction with standard therapies in the management of cystic
fibrosis patients to reduce the frequency of respiratory infections
requiring parenteral antibiotics and to improve pulmonary function.
Trade Name:
Pulmozyme Orphan Designation:
To reduce mucous viscosity and enable the clearance of airway
secretions in patients with cystic fibrosis.
Designation
1/16/1991 Sponsor and Address
Marketing Exclusivity Genentech, Inc.
12/30/1993 460 Point San Bruno Boulevard
South San Francisco CA 94080

***************************************************************************************
Generic Name Approved Orphan Indication:
Dovitinib

Trade Name:
Orphan Designation:
Treatment of multiple myeloma

Designation
10/3/2006 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
Doxorubicin HCL liposome injection For use in combination with bortezomib for the treatment of patients
with multiple myeloma who have not previously received bortezomib
and have at least one prior
Trade Name: therapy.
Doxil Orphan Designation:
Treatment of multiple myeloma

Designation
12/29/2004 Sponsor and Address
Marketing Exclusivity Johnson & Johnson Pharmaceutical Research & Dev.
5/17/2007 920 US Highway 202, P. O. Box 300
Raritan NJ 08869

***************************************************************************************
Generic Name Approved Orphan Indication:
Doxorubicin HCl with pluronic L-61 and pluronic F-127

Trade Name:
Orphan Designation:
Treatment of esophageal carcinoma

Designation
10/7/2005 Sponsor and Address
Marketing Exclusivity Supratek Pharma Inc.
215Bouchard Blvd
Dorval
Quebec H9S 1A9
CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Doxorubicin liposome Treatment of metastatic carcinoma of the ovary in patients with
disease that is refractory to both paclitaxel- and platinium-based
chemotherapy regimens. Refractory disease is defined as disease
Trade Name: that has progressed while on treatment, or within 6 months of
Doxil Orphan Designation:
Treatment of ovarian cancer.

Designation
11/4/1998 Sponsor and Address
Marketing Exclusivity Alza Corporation
6/28/1999 1550 Plymouth St.
PO Box 7210
Mountain View CA 94039-7210
***************************************************************************************
Generic Name Approved Orphan Indication:
doxorubicin PIHCA nanoparticles

Trade Name:
Doxorubicin Transdrug Orphan Designation:
Treatment of hepatocellular carcinoma

Designation
3/14/2005 Sponsor and Address
Marketing Exclusivity BioAlliance Pharma
59, Bd Gal Martial Valin - 75015
Paris

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
D-peptide of the sequence AKRHHGYKRKFH - NH2

Trade Name:
PulmaDex Orphan Designation:
Treatment of cystic fibrosis

Designation
10/23/2002 Sponsor and Address
Marketing Exclusivity Demegen, Inc.
100 Technology Drive
Suite 440 B
Pittsburgh PA 15219
***************************************************************************************
Generic Name Approved Orphan Indication:
Dronabinol Treatment of anorexia associated with weight loss in patients with
AIDS.

Trade Name:
Marinol Orphan Designation:
For the stimulation of appetite and prevention of weight loss in
patients with a confirmed diagnosis of AIDS.
Designation
1/15/1991 Sponsor and Address
Marketing Exclusivity Unimed Pharmaceuticals, Inc.
12/22/1992 901 Sawyer Rd.
Marietta GA 30062

***************************************************************************************
Generic Name Approved Orphan Indication:
Droxidopa

Trade Name:
Orphan Designation:
Treatment of neurogenic symptomatic orthostatic hypotension in
patients with primary autonomic failure, dopamine-beta-hydroxylase
Designation deficiency, and nondiabetic autonomic neuropathy.
1/17/2007 Sponsor and Address
Marketing Exclusivity Chelsea Therapeutics, Inc.
13950 Ballantyne Corporate Place
Charlotte NC 28277

***************************************************************************************
Generic Name Approved Orphan Indication:
Duramycin

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis.

Designation
12/11/1997 Sponsor and Address
Marketing Exclusivity MoliChem Medicines Inc.
207 South Elliott Road PMB#231
Chapel Hill NC 27514

***************************************************************************************
Generic Name Approved Orphan Indication:
Dynamine

Trade Name:
Orphan Designation:
Treatment of hereditary motor and sensory neuropathy type I
(Charcot-Marie-Tooth disease).
Designation
10/16/1991 Sponsor and Address
Marketing Exclusivity Mayo Foundation
200 First Street Southwest
Rochester MN 55905

***************************************************************************************
Generic Name Approved Orphan Indication:
Dynamine

Trade Name:
Orphan Designation:
Treatment of Lambert Eaton myasthenic syndrome.

Designation
2/5/1990 Sponsor and Address
Marketing Exclusivity Mayo Foundation
200 First Street Southwest
Rochester MN 55905

***************************************************************************************
Generic Name Approved Orphan Indication:
eculizumab

Trade Name:
Orphan Designation:
Idiopathic membranous glomerular nephropathy

Designation
3/5/2001 Sponsor and Address
Marketing Exclusivity Alexion Pharmaceuticals, Inc.
352 Knotter Drive
Cheshire CT 06410

***************************************************************************************
Generic Name Approved Orphan Indication:
eculizumab Treatment of paroxysmal nocturnal hemoglobinuria to reduce
hemolysis

Trade Name:
Soliris Orphan Designation:
Treatment of paroxysmal nocturnal hemoglobinuria

Designation
8/20/2003 Sponsor and Address
Marketing Exclusivity Alexion Pharmaceuticals, Inc.
3/16/2007 352 Knotter Drive
Cheshire CT 06410

***************************************************************************************
Generic Name Approved Orphan Indication:
Edotreotide

Trade Name:
OctreoTher Orphan Designation:
Treatment of somatostatin receptor-positive neuroendocrine
gastroenteropancreatic tumors
Designation
7/28/2005 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corp.
59 Route 10/Bldg 122/N142
One Health Plaza
East Hanover NJ 07936-1080
***************************************************************************************
Generic Name Approved Orphan Indication:
Efaproxiral

Trade Name:
Orphan Designation:
Adjunct to whole brain radiation therapy for the treatment of brain
metastases in patients with breast cancer
Designation
7/28/2004 Sponsor and Address
Marketing Exclusivity Allos Therapeutics, Inc.
11080 CirclePoint Road
Suite 200
Westminster CO 80020
***************************************************************************************
Generic Name Approved Orphan Indication:
Eflornithine

Trade Name:
Orphan Designation:
Treatment of anaplastic glioma

Designation
9/29/2006 Sponsor and Address
Marketing Exclusivity VBL Pharmaceuticals, Inc.
460 Seaport Court
Redwood City CA 94063

***************************************************************************************
Generic Name Approved Orphan Indication:
Eflornithine HCl

Trade Name:
Ornidyl Orphan Designation:
Treatment of Pneumocystis carinii pneumonia in AIDS patients.

Designation
4/18/1986 Sponsor and Address
Marketing Exclusivity Marion Merrell Dow, Inc.
P.O. Box 9627
Kansas City MO 64134

***************************************************************************************
Generic Name Approved Orphan Indication:
Eflornithine HCl

Trade Name:
Ornidyl Orphan Designation:
Treatment of Trypanosoma brucei gambiense infection (sleeping
sickness).
Designation
4/23/1986 Sponsor and Address
Marketing Exclusivity Hoechst Marion Roussel
11/28/1990 P.O. Box 9627
Kansas City MO 64134

***************************************************************************************
Generic Name Approved Orphan Indication:
Elcatonin

Trade Name:
Orphan Designation:
Intrathecal treatment of intractable pain.

Designation
9/25/1995 Sponsor and Address
Marketing Exclusivity Innapharma, Inc.
10 Mountainview Road
Upper Saddle River NJ 07458

***************************************************************************************
Generic Name Approved Orphan Indication:
Enadoline hydrochloride

Trade Name:
Orphan Designation:
Treatment of severe head injury.

Designation
1/28/1997 Sponsor and Address
Marketing Exclusivity Warner-Lambert Company
Parke-Davis Pharmaceutical Research Division
2800 Plymouth Road
Ann Arbor MI 48105
***************************************************************************************
Generic Name Approved Orphan Indication:
Encapsulated porcine islet preparation

Trade Name:
BetaRx Orphan Designation:
Treatment of type I diabetic patients who are already on
immunosuppression.
Designation
7/5/1995 Sponsor and Address
Marketing Exclusivity VivoRx
2825 Santa Monica Blvd.
2nd Floor
Santa Monica CA 90404-2429
***************************************************************************************
Generic Name Approved Orphan Indication:
Eniluracil

Trade Name:
Orphan Designation:
Treatment of hepatocellular carcinoma

Designation
12/15/2005 Sponsor and Address
Marketing Exclusivity Adherex Technologies, Inc.
4620 Creekstone Drive
Research Triangle Park
Durham NC 27703
***************************************************************************************
Generic Name Approved Orphan Indication:
Enisoprost

Trade Name:
Orphan Designation:
For use in organ transplant patients to diminish the nephrotoxicity
induced by cyclosporine.
Designation
10/20/1989 Sponsor and Address
Marketing Exclusivity G.D. Searle & Company
4901 Searle Parkway
Skokie IL 60077

***************************************************************************************
Generic Name Approved Orphan Indication:
Enisoprost

Trade Name:
Orphan Designation:
For use with cyclosporine in organ transplant recipients to reduce
acute transplant rejection.
Designation
10/20/1989 Sponsor and Address
Marketing Exclusivity G.D. Searle & Company
4901 Searle Parkway
Skokie IL 60077

***************************************************************************************
Generic Name Approved Orphan Indication:
Enteric-coated cysteamine

Trade Name:
Orphan Designation:
Treatment of cystinosis

Designation
10/24/2006 Sponsor and Address
Marketing Exclusivity Univ of Cal. San Diego Medical Center, Hillcrest
200 West Arbor Drive
San Diego CA 92103-8450

***************************************************************************************
Generic Name Approved Orphan Indication:
Enzastaurin

Trade Name:
Orphan Designation:
Treatment of glioblastoma multiforme

Designation
9/19/2005 Sponsor and Address
Marketing Exclusivity Eli Lilly and Company
Lilly Corporate Center
Indianapolis IN 46285

***************************************************************************************
Generic Name Approved Orphan Indication:
Epidermal growth factor (human)

Trade Name:
Orphan Designation:
For acceleration of corneal epithelial regeneration and the healing
of stromal tissue in the condition of non-healing corneal defects.
Designation
10/5/1987 Sponsor and Address
Marketing Exclusivity Chiron Vision
500 Iolab Drive
Claremont CA 91711

***************************************************************************************
Generic Name Approved Orphan Indication:
Epidermal growth factor (human)

Trade Name:
Orphan Designation:
For promotion of cutaneous wound healing in extreme burn
treatment protocols.
Designation
3/6/1985 Sponsor and Address
Marketing Exclusivity Ethicon, Inc.
P.O. Box 151
Somerville NJ 08876

***************************************************************************************
Generic Name Approved Orphan Indication:
Epirubicin Component of adjuvant therapy in patients with evidence of axillary
node tumor involvement following resection of primary breast cancer.

Trade Name:
Ellence Orphan Designation:
Treatment of breast cancer.

Designation
9/14/1999 Sponsor and Address
Marketing Exclusivity Pharmacia & Upjohn Company
9/15/1999 0634-298-113
7000 Portage Rd.
Kalamazoo MI 49001-0199
***************************************************************************************
Generic Name Approved Orphan Indication:
Epoetin alfa Treatment of AZT-induced anemia in HIV infected patients.

Trade Name:
Epogen Orphan Designation:
Treatment of anemia associated with HIV infection or HIV treatment.

Designation
7/1/1991 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
12/31/1990 1840 Dehavilland Drive
Thousand Oaks CA 91320

***************************************************************************************
Generic Name Approved Orphan Indication:
Epoetin alfa

Trade Name:
Epogen Orphan Designation:
Treatment of anemia associated with end stage renal disease.

Designation
4/10/1986 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
6/1/1989 1840 Dehavilland Drive
Thousand Oaks CA 91320

***************************************************************************************
Generic Name Approved Orphan Indication:
Epoetin alfa

Trade Name:
Orphan Designation:
Treatment of myelodysplastic syndrome.

Designation
12/20/1993 Sponsor and Address
Marketing Exclusivity Johnson & Johnson Pharmaceutical Research & Dev.,
920 U.S. Highway
Route 202, P.O. Box 300
Raritan NJ 08869-0602
***************************************************************************************
Generic Name Approved Orphan Indication:
Epoetin alpha

Trade Name:
Procrit Orphan Designation:
Treatment of anemia associated with end stage renal disease.

Designation
8/27/1987 Sponsor and Address
Marketing Exclusivity R. W. Johnson Pharmaceutical Research Institute
Route 202 South
P.O. Box 300
Raritan NJ 08869
***************************************************************************************
Generic Name Approved Orphan Indication:
Epoetin alpha

Trade Name:
Procrit Orphan Designation:
Treatment of anemia of prematurity in preterm infants.

Designation
7/21/1988 Sponsor and Address
Marketing Exclusivity Johnson & Johnson Pharmaceutical R & D, LLC
920 US Highway 202
P.O. Box 300
Raritan NJ 08869-0602
***************************************************************************************
Generic Name Approved Orphan Indication:
Epoetin alpha

Trade Name:
Procrit Orphan Designation:
Treatment of HIV associated anemia related to HIV infection or HIV
treatment.
Designation
3/7/1989 Sponsor and Address
Marketing Exclusivity R. W. Johnson Pharmaceutical Research Institute
Route 202, P.O. Box 300
Raritan NJ 08869

***************************************************************************************
Generic Name Approved Orphan Indication:
Epoetin beta

Trade Name:
Marogen Orphan Designation:
Treatment of anemia associated with end stage renal disease.

Designation
10/22/1987 Sponsor and Address
Marketing Exclusivity Chugai-USA, Inc.
3780 Hawthorn Court
Waukegan IL 60087

***************************************************************************************
Generic Name Approved Orphan Indication:
Epoprostenol For the long-term intravenous treatment of pulmonary hypertension
associated with the scleroderma spectrum of disease in New York
Heart Association (NYHA) Class III and Class IV patients who do not
Trade Name: respond adequately to conventional therapy.
Flolan Orphan Designation:
Treatment of secondary pulmonary hypertension due to intrinsic
precapillary pulmonary vascular disease.
Designation
3/22/1999 Sponsor and Address
Marketing Exclusivity GlaxoSmithKline
4/14/2000 Five Moore Dr.
PO Box 13398
Research Triangle Park NC 27709-3398
***************************************************************************************
Generic Name Approved Orphan Indication:
Epoprostenol Long-term intravenous treatment of primary pulmonary hypertension
in NYHA Class III and Class IV patients.

Trade Name:
Flolan Orphan Designation:
Treatment of primary pulmonary hypertension.

Designation
9/25/1985 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Inc.
9/20/1995 5 Moore Drive
Research Triangle Park NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Epoprostenol

Trade Name:
Flolan Orphan Designation:
Replacement of heparin in patients requiring hemodialysis and who
are at increased risk of hemorrhage.
Designation
3/29/1984 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Inc.
5 Moore Drive
Research Triangle Park NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Epoprostenol

Trade Name:
Cycloprostin Orphan Designation:
Replacement of heparin in patients requiring hemodialysis and who
are at increased risk of hemorrhage.
Designation
10/29/1984 Sponsor and Address
Marketing Exclusivity Upjohn Company
301 Henrietta Street
Kalamazoo MI 49001

***************************************************************************************
Generic Name Approved Orphan Indication:
epratuzumab

Trade Name:
LymphoCIDE Orphan Designation:
Treatment of non-Hodgkin's lymphoma.

Designation
7/13/1998 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Eprodisate

Trade Name:
Fibrillex Orphan Designation:
Treatment of secondary amyloidosis

Designation
4/6/1999 Sponsor and Address
Marketing Exclusivity Neurochem, Inc.
7220 Frederick Banting, Suite 100
Saint-Laurent
Quebec H4S 2A1
CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Epstein Barr Virus specific cytotoxic T lymphocytes

Trade Name:
Orphan Designation:
Prevention and treatment of EBV-post transplant lymphoproliferative
disease after hematopoietic stem cell transplant or solid organ
Designation transplant.
12/27/2006 Sponsor and Address
Marketing Exclusivity Center for Cell and Gene Therapy
Feigin Center
Suite 1120
Houston TX 77030-2399
***************************************************************************************
Generic Name Approved Orphan Indication:
Erlotinib Hydrochloride

Trade Name:
Tarceva Orphan Designation:
Treatment of malignant gliomas

Designation
7/18/2003 Sponsor and Address
Marketing Exclusivity Genentech, Inc
1 DNA Way
South San Francisco CA 94080-4990

***************************************************************************************
Generic Name Approved Orphan Indication:
Erwinia L-asparaginase

Trade Name:
Erwinase Orphan Designation:
Treatment of acute lymphocytic leukemia.

Designation
7/30/1986 Sponsor and Address
Marketing Exclusivity EUSA Pharma (US), Inc.
1980 South Easton Road
Suite 250
Doylestown PA 18901
***************************************************************************************
Generic Name Approved Orphan Indication:
Erwinia L-asparaginase

Trade Name:
Orphan Designation:
For use as an alternative to E. coli asparaginase in those situations
where repeat courses of asparaginase therapy for acute lymphoblastic
Designation leukemia are required or where allergic reactions force the
1/25/1985 discontinuance of the E. coli preparation.
Sponsor and Address
Marketing Exclusivity Lyphomed, Inc.

***************************************************************************************
Generic Name Approved Orphan Indication:
Erythropoietin (human, recombinant)

Trade Name:
Orphan Designation:
Treatment of anemia associated with end stage renal disease.

Designation
11/19/1987 Sponsor and Address
Marketing Exclusivity Organon Teknika Corporation

***************************************************************************************
Generic Name Approved Orphan Indication:
Erythropoietin (recombinant human)

Trade Name:
Orphan Designation:
Treatment of anemia associated with end stage renal disease.

Designation
8/19/1987 Sponsor and Address
Marketing Exclusivity McDonnell Douglas Corp
P.O. Box 516, 107/2 MS10
St. Louis MO 63166

***************************************************************************************
Generic Name Approved Orphan Indication:
Estradiol Gel

Trade Name:
EstroGel Orphan Designation:
Estrogen replacement therapy in females with Turner syndrome

Designation
10/31/2006 Sponsor and Address
Marketing Exclusivity Ascend Therapeutics, Inc.
607 Herndon Parkway
Herndon VA 21070

***************************************************************************************
Generic Name Approved Orphan Indication:
Etanercept Reduction in signs and symptoms of moderately to severely active
polyarticular-course juvenile rheumatoid arthritis in patients who have
had an inadequate response to one or more disease-modifying anti-
Trade Name: rheumatic drugs.
Enbrel Orphan Designation:
Reduction in signs and symptoms of moderately to severely active
polyarticular-course juvenile rheumatoid arthritis in patients who have
Designation had an inadequate response to one or more disease-modifying anti-
10/27/1998 rheumatic drugs.
Sponsor and Address
Marketing Exclusivity Immunex Corporation
5/27/1999 51 University St.
Seattle WA 98101-2936

***************************************************************************************
Generic Name Approved Orphan Indication:
Ethanol gel

Trade Name:
Orphan Designation:
Treatment of congenital lymphatic malformations

Designation
3/13/2006 Sponsor and Address
Marketing Exclusivity Orfagen
Parc Technologique du Canal
31521 Ramonville Saint Agne Cedex

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
Ethanol gel

Trade Name:
Orphan Designation:
Treatment of congenital venous malformations

Designation
3/29/2006 Sponsor and Address
Marketing Exclusivity Orfagen
Parc Technologique du Canal
31521 Ramonville Saint Agne Cedex

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
Ethanolamine oleate

Trade Name:
Ethamolin Orphan Designation:
Treatment of patients with esophageal varices that have recently
bled, to prevent rebleeding.
Designation
3/22/1984 Sponsor and Address
Marketing Exclusivity Block Drug Company, Inc.
12/22/1988 257 Cornelison Avenue
Jersey City NJ 07302

***************************************************************************************
Generic Name Approved Orphan Indication:
Ethinyl Estradiol, USP

Trade Name:
Orphan Designation:
Treatment of Turner's syndrome.

Designation
6/22/1988 Sponsor and Address
Marketing Exclusivity Bio-Technology General Corp.
70 Wood Avenue, South
Iselin NJ 08830

***************************************************************************************
Generic Name Approved Orphan Indication:
Ethiofos

Trade Name:
Orphan Designation:
Use as a chemoprotective agent for cisplatin and cyclophosphamide
in the treatment of ovarian cancer.
Designation
8/1/1989 Sponsor and Address
Marketing Exclusivity U.S. Bioscience
100 Front Street
West Conshohocken PA 19428

***************************************************************************************
Generic Name Approved Orphan Indication:
Ethyl eicosapentaenoate

Trade Name:
Orphan Designation:
Treatment of Huntington's disease.

Designation
4/6/2000 Sponsor and Address
Marketing Exclusivity Laxdale Ltd.
Kings Park House, Laurelhill Business Park
Polmaise Road, Stirling FK7 9JQ

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Etidronate disodium

Trade Name:
Didronel IV infusion Orphan Designation:
Prevention of degenerative metabolic bone disease occurring in
patients who require long term (6 months or greater) total parenteral
Designation nutrition.
5/2/1991 Sponsor and Address
Marketing Exclusivity MGI Pharma, Inc.
6300 West Old Shakoppe Rd.
Suite 110
Bloomington MN 55438-2318
***************************************************************************************
Generic Name Approved Orphan Indication:
Etidronate disodium

Trade Name:
Didronel IV Infusion Orphan Designation:
Treatment of degenerative metabolic bone disease occurring in
patients who require long term (6 months or greater) total parenteral
Designation nutrition.
5/2/1991 Sponsor and Address
Marketing Exclusivity MGI Pharma, Inc.
6300 West Old Shakoppe Rd.
Suite 110
Bloomington MN 55438-2318
***************************************************************************************
Generic Name Approved Orphan Indication:
Etidronate disodium

Trade Name:
Didronel Orphan Designation:
Treatment of hypercalcemia of malignancy inadequately managed
by dietary modification and/or oral hydration.
Designation
3/21/1986 Sponsor and Address
Marketing Exclusivity MGI Pharma, Inc.
4/21/1987 5775 West Old Shakoppe Rd.
Suite 100
Bloomington MN 55437-3107
***************************************************************************************
Generic Name Approved Orphan Indication:
Etiocholanedione

Trade Name:
Orphan Designation:
Treatment of Prader-Willi syndrome.

Designation
5/7/1996 Sponsor and Address
Marketing Exclusivity SuperGen, Inc.
Two Annabel Lane, Suite 220
San Ramon CA 94583

***************************************************************************************
Generic Name Approved Orphan Indication:
Etiocholanedione

Trade Name:
Orphan Designation:
Treatment of aplastic anemia.

Designation
11/3/1995 Sponsor and Address
Marketing Exclusivity SuperGen, Inc.
Two Annabel Lane, Suite 220
Suite 10
San Ramon CA 94583
***************************************************************************************
Generic Name Approved Orphan Indication:
Ex vivo cultured adult human mesenchymal stem
cells
Trade Name:
Prochymal Orphan Designation:
Treatment of acute graft versus host disease

Designation
12/14/2005 Sponsor and Address
Marketing Exclusivity Osiris Therpeutics, Inc.
2001 Aliceanna Street
Baltimore MD 21231-3043

***************************************************************************************
Generic Name Approved Orphan Indication:
Exemestane Treatment of advanced breast cancer in postmenopausal women
whose disease has progressed following tamoxifen therapy.

Trade Name:
Aromasin Orphan Designation:
Treatment of advanced breast cancer in postmenopausal women
whose disease has progressed following tamoxifen therapy.
Designation
9/19/1991 Sponsor and Address
Marketing Exclusivity Pharmacia & Upjohn
10/21/1999 7000 Portage Road
Mail Stop: 0636-298-113
Kalamazoo MI 49001-0199
***************************************************************************************
Generic Name Approved Orphan Indication:
Exisulind

Trade Name:
Orphan Designation:
For the suppression and control of colonic adenomatous polyps in the
inherited disease adenomatous polyposis coli.
Designation
2/14/1994 Sponsor and Address
Marketing Exclusivity OSI Pharmaceuticals, Inc.
58 South Service Road
Suite 110
Melville NY 11747
***************************************************************************************
Generic Name Approved Orphan Indication:
Factor XIII [A2] homodimer, recombinant DNA origin

Trade Name:
Orphan Designation:
Treatment of congenital FXIII deficiency

Designation
5/21/2003 Sponsor and Address
Marketing Exclusivity Novo Nordisk Pharmaceuticals, INc.
100 College Road West
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Factor XIII [A2} homodimer, recombinant DNA origin

Trade Name:
Orphan Designation:
For the prophylaxis of bleeding associated with congential FXIII
deficiency
Designation
11/6/2003 Sponsor and Address
Marketing Exclusivity Novo Nordisk, Inc.
100 College Road West
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
factor XIII concentrate (human), pasteurized

Trade Name:
Fibrogammin P Orphan Designation:
Treatment of congenital factor XIII deficiency.

Designation
1/16/1985 Sponsor and Address
Marketing Exclusivity CSL Behring L.L.C.
1020 First Ave.
PO Box 61501
King of Prussia PA 19406-0901
***************************************************************************************
Generic Name Approved Orphan Indication:
Factor XIII, recombinant

Trade Name:
Orphan Designation:
Treatment of congenital factor XIII deficiency.

Designation
4/22/1993 Sponsor and Address
Marketing Exclusivity Zymogenetics, Inc.
4225 Roosevelt Way
Seattle WA 98105

***************************************************************************************
Generic Name Approved Orphan Indication:
Fampridine

Trade Name:
Neurelan Orphan Designation:
Treatment of chronic, incomplete spinal cord injury.

Designation
6/2/1997 Sponsor and Address
Marketing Exclusivity Acorda Therapeutics, Inc.
15 Skyline Dr.
Hawthorne NY 10532

***************************************************************************************
Generic Name Approved Orphan Indication:
Fampridine

Trade Name:
Neurelan Orphan Designation:
Relief of symptoms of multiple sclerosis.

Designation
6/2/1987 Sponsor and Address
Marketing Exclusivity Acorda Therapeutics
15 Skyline Dr.
Hawthorne NY 10532

***************************************************************************************
Generic Name Approved Orphan Indication:
Felbamate As adjunctive therapy in the treatment of partial and generalized
seizures associated with the Lennox-Gastaut syndrome in children.

Trade Name:
Felbatol Orphan Designation:
Treatment of Lennox-Gastaut syndrome.

Designation
1/24/1989 Sponsor and Address
Marketing Exclusivity Wallace Laboratories
7/29/1993 301B College Road East
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Fenobam hydrochloride

Trade Name:
Orphan Designation:
Treatment of fragile X syndrome

Designation
11/20/2006 Sponsor and Address
Marketing Exclusivity Neuropharm, Ltd.
Fetcham Park House
Leatherhead, Surrey KT22 9HD

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
fenretinide

Trade Name:
Orphan Designation:
Treatment of Ewing's sarcoma family of tumors.

Designation
2/1/2007 Sponsor and Address
Marketing Exclusivity Cancer Research UK
61 Lincoln's Inn Fields
London WC2A 3PX

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Fenretinide

Trade Name:
Orphan Designation:
Treatment of neuroblastoma

Designation
10/5/2005 Sponsor and Address
Marketing Exclusivity USC-CHLA Institute for Pediatric Clinical Research
Childrens Hospital Los Angeles
4650 Sunset Blve, MS 55
Los Angeles CA 90027
***************************************************************************************
Generic Name Approved Orphan Indication:
ferric hexacyanoferrate (II) "Prussian Blue"

Trade Name:
Orphan Designation:
Treatment of patients with known or suspected internal contamination
with radioactive or non-radioactive cesium or thallium
Designation
6/26/2003 Sponsor and Address
Marketing Exclusivity Degussa AG
Weissfrauenstr.9
D-60287
Frankfurt
GERMANY
***************************************************************************************
Generic Name Approved Orphan Indication:
FIAU

Trade Name:
Orphan Designation:
Adjunctive treatment of chronic active hepatitis B.

Designation
7/24/1992 Sponsor and Address
Marketing Exclusivity Oclassen Pharmaceuticals, Inc.
100 Pelican Way
San Rafael CA 94901

***************************************************************************************
Generic Name Approved Orphan Indication:
Fibrinogen (human)

Trade Name:
Orphan Designation:
For the control of bleeding and prophylactic treatment of patients
deficient in fibrinogen.
Designation
8/23/1995 Sponsor and Address
Marketing Exclusivity Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles CA 90032

***************************************************************************************
Generic Name Approved Orphan Indication:
Fibronectin (human plasma derived)

Trade Name:
Orphan Designation:
Treatment of non-healing corneal ulcers or epithelial defects which
have been unresponsive to conventional therapy and the underlying
Designation cause has been eliminated.
9/5/1988 Sponsor and Address
Marketing Exclusivity Melville Biologics, Inc.
310 East 67th Street
New York NY 10021

***************************************************************************************
Generic Name Approved Orphan Indication:
Fibronectin (plasma derived)

Trade Name:
Orphan Designation:
Treatment of non-healing corneal ulcers or epithelial defects which
are unresponsive to conventional therapy and for which any
Designation infectious cause of the defect has been eliminated.
12/5/1988 Sponsor and Address
Marketing Exclusivity Chiron Vision
9342 Jeronimo Road
Irvine CA 92718

***************************************************************************************
Generic Name Approved Orphan Indication:
Filgrastim Treatment of patients with severe chronic neutropenia.

Trade Name:
Neupogen Orphan Designation:
Treatment of patients with severe chronic neutropenia (absolute
neutrophil count less than 500/mm3).
Designation
11/7/1990 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
12/19/1994 1840 Dehavilland Drive
Thousand Oaks CA 91320

***************************************************************************************
Generic Name Approved Orphan Indication:
Filgrastim

Trade Name:
Neupogen Orphan Designation:
Treatment of myelodysplastic syndrome.

Designation
8/30/1990 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
1840 Dehavilland Drive
Thousand Oaks CA 91320

***************************************************************************************
Generic Name Approved Orphan Indication:
Filgrastim Reduce the duration of neutropenia and neutropenia sequelae in
patients with non-myeloid malignancies undergoing ablative
chemotherapy followed by BMT.
Trade Name:
Neupogen Orphan Designation:
Treatment of neutropenia associated with bone marrow transplants.

Designation
10/1/1990 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
6/15/1994 1840 Dehavilland Drive
Thousand Oaks CA 91320

***************************************************************************************
Generic Name Approved Orphan Indication:
Filgrastim Reducing the time to neutrophil recovery and the duration of fever,
following induction or consolidation chemotherapy treatment of
adults with acute myeloid leukemia.
Trade Name:
Neupogen Orphan Designation:
Reduction in the duration of neutropenia, fever, antibiotic use, and
hospitalization, following induction and consolidation treatment for
Designation acute myeloid leukemia.
11/7/1996 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
4/2/1998 One Amgen Center Dr.
Thousand Oaks CA 91320-1799

***************************************************************************************
Generic Name Approved Orphan Indication:
Filgrastim

Trade Name:
Neupogen Orphan Designation:
Treatment of patients with AIDS who, in addition, are afflicted with
cytomegalovirus retinitis and are being treated with ganciclovir.
Designation
9/3/1991 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
One Amgen Center Dr.
Thousand Oaks CA 91320-1799

***************************************************************************************
Generic Name Approved Orphan Indication:
Filgrastim For use in the mobilization of hematopoietic progenitor cells into the
peripheral blood collection by leukapheresis.

Trade Name:
Neupogen Orphan Designation:
For use in the mobilization of peripheral blood progenitor cells for
collection in patients who will receive myeloablative or
Designation myelosuppressive chemotherapy.
7/17/1995 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
12/28/1995 1840 Dehavilland Drive
Thousand Oaks CA 91320

***************************************************************************************
Generic Name Approved Orphan Indication:
Floxuridine, FUDR

Trade Name:
Orphan Designation:
Intraperitoneal treatment of gastric cancer.

Designation
12/22/2004 Sponsor and Address
Marketing Exclusivity Franco Muggia, M.D.
160 East 34th Street
New York NY 10016

***************************************************************************************
Generic Name Approved Orphan Indication:
Fludarabine phosphate

Trade Name:
Fludara Orphan Designation:
Treatment of chronic lymphocytic leukemia (CLL), including
refractory CLL.
Designation
4/18/1989 Sponsor and Address
Marketing Exclusivity Berlex Laboratories, Inc.
4/18/1991 15049 San Pablo Avenue, P.O. Box 4099
Richmond CA 94804

***************************************************************************************
Generic Name Approved Orphan Indication:
Fludarabine phosphate

Trade Name:
Fludara Orphan Designation:
Treatment and management of patients with non-Hodgkins
lymphoma.
Designation
4/18/1989 Sponsor and Address
Marketing Exclusivity Berlex Laboratories, Inc.
15049 San Pablo Avenue
P.O. Box 4099
Richmond CA 94804-0099
***************************************************************************************
Generic Name Approved Orphan Indication:
Flumecinol

Trade Name:
Zixoryn Orphan Designation:
Treatment of hyperbilirubinemia in newborn infants unresponsive to
phototherapy.
Designation
1/15/1985 Sponsor and Address
Marketing Exclusivity Farmacon, Inc.
Post House, Suite 213
1720 Post Road East
Westport CT 06880-5643
***************************************************************************************
Generic Name Approved Orphan Indication:
Flunarizine

Trade Name:
Sibelium Orphan Designation:
Treatment of alternating hemiplegia.

Designation
1/6/1986 Sponsor and Address
Marketing Exclusivity Janssen Research Foundation

P.O. Box 200


Titusville NJ 08560
***************************************************************************************
Generic Name Approved Orphan Indication:
Fluocinolone Treatment of chronic non-infectious uveitis affecting the posterior
segment of the eye

Trade Name:
Retisert Orphan Designation:
Treatment uveitis involving the posterior segment of the eye.

Designation
7/31/2000 Sponsor and Address
Marketing Exclusivity Bausch & Lomb Pharmaceuticals, Inc.
4/8/2005 8500 Hidden River Parkway
Tampa FL 33637

***************************************************************************************
Generic Name Approved Orphan Indication:
Fluorouracil

Trade Name:
Adrucil Orphan Designation:
For use in combination with leucovorin for therapy of metastatic
adenocarcinoma of the colon and rectum.
Designation
2/6/1989 Sponsor and Address
Marketing Exclusivity Lederle Laboratories
Division of American Cyanamid Company
401 N. Middletown Road
Pearl River NY 10965
***************************************************************************************
Generic Name Approved Orphan Indication:
Fluorouracil

Trade Name:
Orphan Designation:
For use in combination with interferon alpha-2a, recombinant, for the
treatment of esophageal carcinoma.
Designation
10/27/1989 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110-1199

***************************************************************************************
Generic Name Approved Orphan Indication:
Fluorouracil

Trade Name:
Orphan Designation:
For use in combination with interferon alpha-2a, recombinant, for the
treatment of advanced colorectal carcinoma.
Designation
4/18/1990 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110-1199

***************************************************************************************
Generic Name Approved Orphan Indication:
Fluorouracil

Trade Name:
Orphan Designation:
Treatment of glioblastoma multiforme.

Designation
6/29/2000 Sponsor and Address
Marketing Exclusivity Ethypharm SA
194 Bureaux de la Colline - Batiment D
92213 Saint-Cloud Cedex

***************************************************************************************
Generic Name Approved Orphan Indication:
Fluoxetine

Trade Name:
Prozac Orphan Designation:
Treatment of body dysmorphic disorder in children and adolescents

Designation
4/14/2004 Sponsor and Address
Marketing Exclusivity Hollander, Eric MD
The Mount Sinai School of Medicine
One Gustave L. Levy Place
New York NY 10029-6574
***************************************************************************************
Generic Name Approved Orphan Indication:
Fluoxetine

Trade Name:
Prozac Orphan Designation:
Treatment of autism.

Designation
4/30/1999 Sponsor and Address
Marketing Exclusivity Mt. Sinai School of Medicine
Dept. of Psychiatry
Box 1230, One Gustave L. Levy Place
New York NY 10029-6574
***************************************************************************************
Generic Name Approved Orphan Indication:
Follitropin alfa, recombinant For the induction of spermatogenesis in men with primary and
secondary hypogonadotropic hypogonadism in whom the cause of
infertility is not due to primary testicular failure.
Trade Name:
Gonal-F Orphan Designation:
For the initiation and re-initiation of spermatogenesis in adult males
with reproductive failure due to hypothalamic or pituitary dysfunction,
Designation hypogonadotropic hypogonadism. AMENDED indication 6/27/00:
12/21/1998 For the induction of spermatogenesis in men with primary and
secondary hypogonadotropic hypogonadism in whom the cause of
infertility is not due to primary testicular failure.
Sponsor and Address
Marketing Exclusivity Serono Laboratories, Inc.
5/24/2000 100 Longwater Circle
Norwell MA 02061

***************************************************************************************
Generic Name Approved Orphan Indication:
Fomepizole Use for suspected or confirmed methanol poisoning, either alone or
in combination with hemodialysis

Trade Name:
Antizole Orphan Designation:
Treatment of methanol or ethylene glycol poisoning.

Designation
12/22/1988 Sponsor and Address
Marketing Exclusivity Jazz Pharmaceuticals
12/8/2000 3180 Porter Drive
Palo Alto CA 94304

***************************************************************************************
Generic Name Approved Orphan Indication:
Fomepizole As an antidote to ethylene glycol (antifreeze) poisoning, or for use in
suspected ethylene glycol ingestion.

Trade Name:
Antizole Orphan Designation:
Treatment of methanol or ethylene glycol poisoning.

Designation
12/22/1988 Sponsor and Address
Marketing Exclusivity Jazz Pharmaceuticals
12/4/1997 3180 Porter Drive
Palo Alto CA 94304

***************************************************************************************
Generic Name Approved Orphan Indication:
Fosphenytoin For the control of generalized convulsive status epilepticus.

Trade Name:
Cerebyx Orphan Designation:
For the acute treatment of patients with status epilepticus of the
grand mal type.
Designation
6/4/1991 Sponsor and Address
Marketing Exclusivity Warner-Lambert Company
8/5/1996 2800 Plymouth Road
Ann Arbor MI 48106

***************************************************************************************
Generic Name Approved Orphan Indication:
Fructose-1,6-diphosphate

Trade Name:
Cordox Orphan Designation:
Treatment of painful vaso-occlusive episodes associated with sickle
cell disease.
Designation
5/29/1998 Sponsor and Address
Marketing Exclusivity Questcor Pharmaceuticals, Inc.
3260 Whipple Road
Union City CA 94587-1217

***************************************************************************************
Generic Name Approved Orphan Indication:
Fusion protein consisting of human immunoglobim
G1 constant region Fc region fused to the human
receptor binding domain of ectodysplasin-A1

Trade Name:
Orphan Designation:
Treatment of X-linked hypohidrotic ectodermal dysplasia

Designation
1/11/2006 Sponsor and Address
Marketing Exclusivity Apoxis SA
Av de Sevelin, 18-20
Lausanne, Switzerland

***************************************************************************************
Generic Name Approved Orphan Indication:
G17DT Immunogen

Trade Name:
Orphan Designation:
Treatment of gastric cancer

Designation
7/18/2002 Sponsor and Address
Marketing Exclusivity Receptor BioLogix, Inc.
1140 Veterans Blvd.
Suite A
South San Francisco CA 94080
***************************************************************************************
Generic Name Approved Orphan Indication:
G17DT Immunogen

Trade Name:
Orphan Designation:
Treatment of adenocarcinoma of the pancreas

Designation
7/10/2002 Sponsor and Address
Marketing Exclusivity Receptor BioLogix, Inc.
1140 Veterans Blvd.
Suite A
South San Francisco CA 94080
***************************************************************************************
Generic Name Approved Orphan Indication:
Gabapentin

Trade Name:
Neurontin Orphan Designation:
Treatment of amyotrophic lateral sclerosis.

Designation
7/5/1995 Sponsor and Address
Marketing Exclusivity Warner-Lambert Company
Parke-Davis Pharmaceutical Research Division
2800 Plymouth Road
Ann Arbor MI 48105
***************************************************************************************
Generic Name Approved Orphan Indication:
Gallium nitrate injection

Trade Name:
Ganite Orphan Designation:
Treatment of hypercalcemia of malignancy.

Designation
12/5/1988 Sponsor and Address
Marketing Exclusivity Solopak Pharmaceutical Co.
1/17/1991 1845 Tonne Road
Elk Grove Village IL 60007

***************************************************************************************
Generic Name Approved Orphan Indication:
Gamma hydroxybutyrate

Trade Name:
Orphan Designation:
Treatment of narcolepsy and the auxiliary symptoms of cataplexy,
sleep paralysis, hypnagogic hallucinations and automatic behavior.
Designation
12/3/1987 Sponsor and Address
Marketing Exclusivity Biocraft Laboratories, Inc.
18-01 River Road
Fair Lawn NJ 07410

***************************************************************************************
Generic Name Approved Orphan Indication:
Gamma-hydroxybutyric acid

Trade Name:
Orphan Designation:
Treatment of narcolepsy and the auxiliary symptoms of cataplexy,
sleep paralysis, hypnagogic hallucinations, and automatic behavior.
Designation
1/22/1985 Sponsor and Address
Marketing Exclusivity Sigma Chemical Company

***************************************************************************************
Generic Name Approved Orphan Indication:
Gammalinolenic acid

Trade Name:
Orphan Designation:
Treatment of juvenile rheumatoid arthritis.

Designation
7/27/1994 Sponsor and Address
Marketing Exclusivity Zurier, Robert B. M.D.
University of Massachusetts Medical Center
55 Lake Avenue
Worcester MA 01655
***************************************************************************************
Generic Name Approved Orphan Indication:
Ganaxolone

Trade Name:
Orphan Designation:
Treatment of infantile spasms.

Designation
5/25/1994 Sponsor and Address
Marketing Exclusivity Marinus Pharmaceuticals, Inc.
21 Business Park Drive
Branford CT 06405

***************************************************************************************
Generic Name Approved Orphan Indication:
Ganciclovir

Trade Name:
Virgan Orphan Designation:
Treatment of acute herpetic keratitis (dendritic and geographic ulcers)

Designation
3/22/2007 Sponsor and Address
Marketing Exclusivity Sirion Therapeutics, Inc.
3110 Cherry Palm Drive
Tampa FL 33619

***************************************************************************************
Generic Name Approved Orphan Indication:
Ganciclovir intravitreal implant Treatment of CMV retinitis in patients with acquired
immunodeficiency syndrome.

Trade Name:
Vitrasert Implant Orphan Designation:
Treatment of cytomegalovirus retinitis.

Designation
6/7/1995 Sponsor and Address
Marketing Exclusivity Bausch & Lomb Surgical, Chiron Vision Products
3/4/1996 9342 Jeronimo Road
Irvine CA 92718-1903

***************************************************************************************
Generic Name Approved Orphan Indication:
Ganciclovir sodium

Trade Name:
Cytovene Orphan Designation:
Treatment of cytomegalovirus retinitis in immunocompromised
patients with AIDS.
Designation
10/31/1985 Sponsor and Address
Marketing Exclusivity Syntex (USA), Inc.
6/23/1989 3401 Hillview Avenue
Palo Alto CA 94304

***************************************************************************************
Generic Name Approved Orphan Indication:
Gancyclovir

Trade Name:
Orphan Designation:
Treatment of severe human cytomegalovirus infections in specific
immunosuppressed patient populations.
Designation
6/7/1985 Sponsor and Address
Marketing Exclusivity Burroughs Wellcome Company
3030 Cornwallis Road
P.O. Box 12700
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Gangliosides as sodium salts

Trade Name:
Cronassial Orphan Designation:
Treatment of retinitis pigmentosa.

Designation
11/17/1988 Sponsor and Address
Marketing Exclusivity Fidia Pharmaceutical Corp.
1401 Eye Street, N.W. Suite 900
Washington DC 20005

***************************************************************************************
Generic Name Approved Orphan Indication:
Gavilimomab

Trade Name:
Orphan Designation:
Acute graft-versus-host disease (aGVHD)

Designation
11/20/2000 Sponsor and Address
Marketing Exclusivity Amgen
One Amgen Center Drive
Mail Stop 17-2-A
Thousand Oaks CA 91320-1799
***************************************************************************************
Generic Name Approved Orphan Indication:
Gemtuzumab zogamicin Treatment of patients with CD33 positive acute myeloid leukemia in
first relapse who are 60 years of age or older and who are not
considered candidates for cytotoxic chemotherapy
Trade Name:
Mylotarg Orphan Designation:
Treatment of CD33-positive acute myeloid leukemia.

Designation
11/24/1999 Sponsor and Address
Marketing Exclusivity Wyeth-Ayerst Laboratories
5/17/2000 PO Box 8299
Philadelphia PA 19101-8299

***************************************************************************************
Generic Name Approved Orphan Indication:
Gene plasmid hVEGF165 driven by human
cytomegalovirus, and [2,3-bis(oleoyl)propyl]trimethyl
ammonium and dioleoyl phosphatidyl ethanolamine

Trade Name:
Trinam Orphan Designation:
Prevention of complications due to neointimal hyperplasia disease in
certain vascular anastomoses.
Designation
10/24/2000 Sponsor and Address
Marketing Exclusivity Ark Therapeutics Ltd.
1 Fitzroy Mews
London W1T6DE

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
genetically engineered herpes simplex virus (G207)

Trade Name:
Orphan Designation:
Tretament of malignant glioma

Designation
4/29/2002 Sponsor and Address
Marketing Exclusivity MediGene, Inc.
10660 Scripps Ranch Blvd.
Suite 200
San Diego CA 92131
***************************************************************************************
Generic Name Approved Orphan Indication:
Geneticin

Trade Name:
Orphan Designation:
Treatment of amoebiasis.

Designation
6/6/2005 Sponsor and Address
Marketing Exclusivity ProcesScience, Inc (PSI)
505 Irving Avenue
Syracuse NY 13210

***************************************************************************************
Generic Name Approved Orphan Indication:
Gentamicin impregnated PMMA beads on surgical
wire
Trade Name:
Septopal Orphan Designation:
Treatment of chronic osteomyelitis of post-traumatic, postoperative,
or hematogenous origin.
Designation
1/31/1991 Sponsor and Address
Marketing Exclusivity Lipha Pharmaceuticals, Inc.
9 West 57th Street
Suite 3825
New York NY 10019-2701
***************************************************************************************
Generic Name Approved Orphan Indication:
Gentamicin liposome injection

Trade Name:
Maitec Orphan Designation:
Treatment of disseminated Mycobacterium avium-intracellulare
infection.
Designation
7/10/1990 Sponsor and Address
Marketing Exclusivity Liposome Company, Inc.
One Research Way
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Glatiramer acetate For reduction of the frequency of relapses in patients with relapsing-
remitting multiple sclerosis.

Trade Name:
Copaxone Orphan Designation:
Treatment of multiple sclerosis.

Designation
11/9/1987 Sponsor and Address
Marketing Exclusivity Teva Pharmaceuticals USA
12/20/1996 1510 Delp Drive
Kulpsville PA 19443

***************************************************************************************
Generic Name Approved Orphan Indication:
Glatiramer acetate for injection

Trade Name:
Copaxone Orphan Designation:
Treatment of primary-progressive multiple sclerosis

Designation
6/5/2001 Sponsor and Address
Marketing Exclusivity TEVA Pharmaceuticals, USA
1090 Horsham Road
North Wales PA 19454

***************************************************************************************
Generic Name Approved Orphan Indication:
glucarpidase

Trade Name:
Voraxaze Orphan Designation:
Treatment of patients at risk of methotrexate toxicity

Designation
8/19/2003 Sponsor and Address
Marketing Exclusivity Protherics, Inc.
5214 Maryland Way, Suite 405
Brentwood TN 37027

***************************************************************************************
Generic Name Approved Orphan Indication:
Glutamine Treatment of short bowel syndrome in patients receiving specialized
nutritional support when used in conjunction with a rercombinant
human growth hormone that is approved for this indication.
Trade Name:
NutreStore Orphan Designation:
For use with human growth hormone in the treatment of short bowel
syndrome (nutrient malabsorption from the gastrointestinal tract
Designation resulting from an inadequate absorptive surface).
3/6/1995 Sponsor and Address
Marketing Exclusivity Nutritional Restart Pharmaceutical, L.P.
6/10/2004 4364 South Alston Avenue
Durham NC 27713

***************************************************************************************
Generic Name Approved Orphan Indication:
Glyceol

Trade Name:
Orphan Designation:
To decrease intracranial hypertension and/or alleviate cerebral
edema in patients who may benefit from osmotherapy.
Designation
2/22/1990 Sponsor and Address
Marketing Exclusivity Chugai Pharmaceutical Co., Ltd.

***************************************************************************************
Generic Name Approved Orphan Indication:
Glyceryl tri (4-phenylbutyrate)

Trade Name:
Orphan Designation:
Treatment of spinal muscular atrophy

Designation
5/24/2005 Sponsor and Address
Marketing Exclusivity Ucyclyd Pharma, Inc
Subsidiary of Medicis Pharmaceutical Corporation
Scottsdale AZ 85258

***************************************************************************************
Generic Name Approved Orphan Indication:
Glyceryl trioleate and glyceryl trierucate

Trade Name:
Orphan Designation:
Treatment of adrenoleukodystrophy.

Designation
2/14/1995 Sponsor and Address
Marketing Exclusivity Moser, Hugo W. M.D.
Johns Hopkins University
Kennedy Krieger Institute, 707 North Broadway
Baltimore MD 21205
***************************************************************************************
Generic Name Approved Orphan Indication:
Glycopyrrolate

Trade Name:
Orphan Designation:
Treatment of pathologic (chronic moderate to severe) drooling in
pediatric patients
Designation
6/9/2006 Sponsor and Address
Marketing Exclusivity Sciele Pharma, Inc.
Five Concourse Parkway
Suite 1800
Atlanta GA 30328
***************************************************************************************
Generic Name Approved Orphan Indication:
Golimumab

Trade Name:
Orphan Designation:
Treatment of chronic sarcoidosis

Designation
11/2/2004 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
Gonadorelin acetate

Trade Name:
Lutrepulse Orphan Designation:
For induction of ovulation in women with hypothalamic amenorrhea
due to a deficiency or absence in the quantity or pulse pattern of
Designation endogenous GnRH secretion.
4/22/1987 Sponsor and Address
Marketing Exclusivity Ferring Laboratories, Inc.
10/10/1989 400 Rella Boulevard, Suite 201
Suffern NY 10901

***************************************************************************************
Generic Name Approved Orphan Indication:
Gossypol

Trade Name:
Orphan Designation:
Treatment of cancer of the adrenal cortex.

Designation
10/22/1990 Sponsor and Address
Marketing Exclusivity Reidenberg, Marcus M. M.D.
The New York Hospital - Cornell Medical Center
525 East 68th Street, Box 70
New York NY 10021
***************************************************************************************
Generic Name Approved Orphan Indication:
Gp100 adenoviral gene therapy

Trade Name:
Orphan Designation:
Treatment of metastatic melanoma.

Designation
3/25/1997 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
500 Kendall Street
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Granulocyte macrophage-colony stimulating factor

Trade Name:
Leucomax Orphan Designation:
Treatment of severe thermal injuries in patients with greater than
40% full or partial thickness burns.
Designation
6/6/1989 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Granulocyte macrophage-colony stimulating factor

Trade Name:
Leucomax Orphan Designation:
Treatment of chronic lymphocytic leukemia to increase granulocyte
count.
Designation
5/4/1990 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Granulocyte macrophage-colony stimulating factor

Trade Name:
Leucomax Orphan Designation:
Treatment of myelodysplastic syndrome.

Designation
8/7/1989 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Granulocyte macrophage-colony stimulating factor

Trade Name:
Leucomax Orphan Designation:
Treatment of neutropenia associated with bone marrow transplants.

Designation
12/12/1989 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Granulocyte macrophage-colony stimulating factor

Trade Name:
Leucomax Orphan Designation:
Treatment of neutropenia due to hairy cell leukemia.

Designation
5/3/1990 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Group B streptococcus immune globulin

Trade Name:
Orphan Designation:
Treatment of neonates for disseminated group B streptococcal
infection.
Designation
5/8/1990 Sponsor and Address
Marketing Exclusivity North American Biologicals, Inc.
12280 Wilkins Avenue
Rockville MD 20852

***************************************************************************************
Generic Name Approved Orphan Indication:
Growth hormone releasing factor

Trade Name:
Orphan Designation:
For the long-term treatment of children who have growth failure due
to a lack of adequate endogenous growth hormone secretion.
Designation
8/7/1989 Sponsor and Address
Marketing Exclusivity Valeant Pharmaceuticals International
One Enterprise Way
Aliso Viejo CA 92656

***************************************************************************************
Generic Name Approved Orphan Indication:
Guanethidine monosulfate

Trade Name:
Ismelin Orphan Designation:
Treatment of moderate to severe reflex sympathetic dystrophy and
causalgia.
Designation
1/6/1986 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
59 Route 10
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
Guanfacine

Trade Name:
Tenex Orphan Designation:
Treatment of fragile X syndrome.

Designation
8/5/1999 Sponsor and Address
Marketing Exclusivity Watson Laboratories, Inc.
311 Bonnie Circle
PO Box 1900
Corona CA 91718-1900
***************************************************************************************
Generic Name Approved Orphan Indication:
Gusperimus

Trade Name:
Spanidin Orphan Designation:
Treatment of acute renal graft rejection episodes.

Designation
6/27/1996 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Pharmaceutical Research Institute
5 Research Parkway
P.O. Box 5100
Wallingford CT 06492-7660
***************************************************************************************
Generic Name Approved Orphan Indication:
h5G1.1-mAb

Trade Name:
Orphan Designation:
Treatment of dermatomyositis

Designation
9/21/2000 Sponsor and Address
Marketing Exclusivity Alexion Pharmaceuticals, Inc.
352 Knotter Drive
Cheshire CT 06410

***************************************************************************************
Generic Name Approved Orphan Indication:
Halofantrine Treatment of adults who can tolerate oral medication and who have
mild to moderate malaria caused by Plasmodium falciparum or
Plasmodium vivax.
Trade Name:
Halfan Orphan Designation:
Treatment of mild to moderate acute malaria caused by susceptible
strains of P. falciparum and P. vivax.
Designation
11/4/1991 Sponsor and Address
Marketing Exclusivity SmithKline Beecham Pharmaceuticals
7/24/1992 One Franklin Plaza
P.O. Box 7929
Philadelphia PA 19101
***************************************************************************************
Generic Name Approved Orphan Indication:
Halofuginone

Trade Name:
Stenorol Orphan Designation:
Treatment of systemic sclerosis.

Designation
2/7/2000 Sponsor and Address
Marketing Exclusivity Collgard Biopharmaceuticals Ltd.
Textile House, 2 Koifman St.
Tel-Aviv 68012

ISRAEL
***************************************************************************************
Generic Name Approved Orphan Indication:
heat killed Mycobacterium w immunomodulator

Trade Name:
CADI Mw Orphan Designation:
Active tuberculosis

Designation
9/3/2004 Sponsor and Address
Marketing Exclusivity Cadila Pharmaceuticals Limited, Inc.
9801 Washingtonian Blvd
Suite 220
Gaithersburg MD 20878
***************************************************************************************
Generic Name Approved Orphan Indication:
heat killed mycobacterium w immunomodulator

Trade Name:
CADI Mw Orphan Designation:
Adjuvant to multi-drug therapy in the management of multibacillary
leprosy
Designation
11/21/2002 Sponsor and Address
Marketing Exclusivity CPL, Inc.
16020 Swingley Ridge Road
Suite 145
Chesterfield MO 63017
***************************************************************************************
Generic Name Approved Orphan Indication:
Heme arginate

Trade Name:
Normosang Orphan Designation:
Treatment of symptomatic stage of acute porphyria.

Designation
3/10/1988 Sponsor and Address
Marketing Exclusivity Orphan Europe
Immeuble Le Guillaumet
92046 Paris La Defense

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
Heme arginate

Trade Name:
Normosang Orphan Designation:
Treatment of myelodysplastic syndromes.

Designation
3/1/1994 Sponsor and Address
Marketing Exclusivity Orphan Europe
Immeuble Le Guillaumet
70 avenue du General de Gaulle,
92056 Paris La Defense
FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
Hemin

Trade Name:
Panhematin Orphan Designation:
Amelioration of recurrent attacks of acute intermittent porphyria (AIP)
temporarily related to the menstrual cycle in susceptible women and
Designation similar symptoms which occur in other patients with AIP, porphyria
3/16/1984 variegata and hereditary coproporphyria.
Sponsor and Address
Marketing Exclusivity Abbott Laboratories
7/20/1983 Diagnostics Division
Abbott Park IL 60064

***************************************************************************************
Generic Name Approved Orphan Indication:
Hemin and zinc mesoporphyrin

Trade Name:
Hemex Orphan Designation:
Treatment of acute porphyric syndromes.

Designation
12/20/1993 Sponsor and Address
Marketing Exclusivity Bonkovsky, Herbert L. M.D.
University Of Massachusetts Medical Center
55 Lake Avenue North
Worcester MA 01655
***************************************************************************************
Generic Name Approved Orphan Indication:
Heparin

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis

Designation
11/3/2005 Sponsor and Address
Marketing Exclusivity Vectura Group, Inc.
1 Prospect West
Wiltshire SN14 6FH

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Heparin sodium

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis

Designation
6/29/2006 Sponsor and Address
Marketing Exclusivity Ockham Biotech Limited
261 Aldwick Road
West Sussex PO21 3QU

UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Heparin-binding epidermal growth factor-like growth
factor
Trade Name:
Orphan Designation:
Prevention and treatment of necrotizing enterocolitis (NEC) in
preterm infants with birth weight less than 1,500 grams
Designation
9/18/2006 Sponsor and Address
Marketing Exclusivity Trillium Therapeutics, Inc.
96 Skyway Avenue
M9W 4Y4

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Hepatitis B immune globulin intravenous (human)

Trade Name:
Nabi-HB Orphan Designation:
Prophylaxis against hepatitis B virus reinfection in liver transplant
patients.
Designation
3/8/1995 Sponsor and Address
Marketing Exclusivity NABI
12280 Wilkins Avenue
Rockville MD 20852

***************************************************************************************
Generic Name Approved Orphan Indication:
Hepatitis C virus immune globulin (human)

Trade Name:
Orphan Designation:
Prophylaxis of hepatitis C infection in liver transplant recipients.

Designation
11/14/2002 Sponsor and Address
Marketing Exclusivity NABI
12276 Wilkins Avenue
Rockville MD 20852

***************************************************************************************
Generic Name Approved Orphan Indication:
HepeX-B

Trade Name:
Orphan Designation:
For the prevention of hepatitis B virus (HBV) reinfection in patients
who have received a liver transplantation
Designation
7/15/2003 Sponsor and Address
Marketing Exclusivity Cubist Pharmaceuticals
65 Hayden Avnue
Lexington MA 02421

***************************************************************************************
Generic Name Approved Orphan Indication:
Herpes simplex virus gene

Trade Name:
Orphan Designation:
Treatment of primary and metastatic brain tumors.

Designation
10/16/1992 Sponsor and Address
Marketing Exclusivity Genetic Therapy, Inc.
938 Clopper Road
Gaithersburg MD 20878

***************************************************************************************
Generic Name Approved Orphan Indication:
Histamine

Trade Name:
Maxamine Orphan Designation:
For use as an adjunct to cytokine therapy in the treatment of
malignant melanoma.
Designation
2/1/2000 Sponsor and Address
Marketing Exclusivity EpiCept Corporation
777 Old Saw Mill River Road
Tarrytown NY 10591

***************************************************************************************
Generic Name Approved Orphan Indication:
Histamine

Trade Name:
Ceplene Orphan Designation:
Adjunct to cytokine therapy in the treatment of acute myeloid
leukemia.
Designation
12/15/1999 Sponsor and Address
Marketing Exclusivity EpiCept Corporation
777 Old Saw Mill River Road
Tarrytown NY 10591

***************************************************************************************
Generic Name Approved Orphan Indication:
Histrelin Treatment of central precocious puberty

Trade Name:
Supprelin LA Orphan Designation:
Treatment of central precocious puberty

Designation
11/18/2005 Sponsor and Address
Marketing Exclusivity Indevus Pharmaceuticals (Formerly Valera Pharma.)
5/3/2007 33 Hayden Avenue
Lexington MA 02421

***************************************************************************************
Generic Name Approved Orphan Indication:
Histrelin

Trade Name:
Orphan Designation:
Treatment of acute intermittent porphyria, hereditary coproporphyria,
and variegate porphyria.
Designation
5/3/1991 Sponsor and Address
Marketing Exclusivity Anderson, Karl E., M.D.
University of Texas Medical Branch at Galveston
Route J-09, 700 The Strand
Galveston TX 77550
***************************************************************************************
Generic Name Approved Orphan Indication:
Histrelin acetate Treatment of central precocious puberty.

Trade Name:
Supprelin Injection Orphan Designation:
Treatment of central precocious puberty.

Designation
8/10/1988 Sponsor and Address
Marketing Exclusivity Roberts Pharmaceutical Corp.
12/24/1991 Meridian Center III
6 Industrial Way West
Eatontown NJ 07724
***************************************************************************************
Generic Name Approved Orphan Indication:
HIV neutralizing antibodies

Trade Name:
Immupath Orphan Designation:
Treatment of acquired immunodeficiency syndrome.

Designation
3/24/1992 Sponsor and Address
Marketing Exclusivity Hemacare Corporation
4954 Van Nuys Boulevard
Sherman Oaks CA 91403

***************************************************************************************
Generic Name Approved Orphan Indication:
HLA-B7/Beta2M DNA Lipid (DMRIE/DOPE) Complex

Trade Name:
Allovectin-7 Orphan Designation:
Treatment of invasive and metastatic melanoma (Stages II, III, and
IV).
Designation
9/30/1999 Sponsor and Address
Marketing Exclusivity Vical Incorporated
9373 Towne Centre Dr., Suite 100
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
homoharringtonine

Trade Name:
Orphan Designation:
Treatment for chronic myelogenous leukemia

Designation
2/8/2002 Sponsor and Address
Marketing Exclusivity American BioScience, Inc.
2730 Wilshire Blvd. #110
Santa Monica CA 90403

***************************************************************************************
Generic Name Approved Orphan Indication:
HPA-23

Trade Name:
Orphan Designation:
Treatment of acquired immunodeficiency syndrome.

Designation
7/17/1985 Sponsor and Address
Marketing Exclusivity Rhone-Poulenc Rorer Pharm.
500 Arcola Road
Collegeville PA 19426

***************************************************************************************
Generic Name Approved Orphan Indication:
Hsp E7

Trade Name:
Orphan Designation:
Treatment of recurrent respiratory papillomatosis (RRP)

Designation
3/19/2001 Sponsor and Address
Marketing Exclusivity StressGen Biotechnologies, Inc. is now Nventa
Nventa Biopharmaceuticals Corporation
6055 Lusk Boulevard
San Diego CA 19426-2655
***************************************************************************************
Generic Name Approved Orphan Indication:
Hu1D10, humanized monoclonal antibody

Trade Name:
Remitogen Orphan Designation:
For use in the treatment of 1D10+ B cell non-Hodgkin's lymphoma

Designation
11/28/2001 Sponsor and Address
Marketing Exclusivity PDL BioPharma, Inc.
34801 Campus Drive
Fremont CA 94555

***************************************************************************************
Generic Name Approved Orphan Indication:
Human acid precursor alpha-glucosidase,
recombinant
Trade Name:
Orphan Designation:
Treatment of glycogen storage disease type II.

Designation
9/10/1996 Sponsor and Address
Marketing Exclusivity Pharming/Genzyme LLC
c/o Genzyme Corporation
1 Mountain Rd.
Framingham MA 01701-9322
***************************************************************************************
Generic Name Approved Orphan Indication:
Human alpha 2,6 sialyltransferase adenoviral gene
therapy

Trade Name:
Orphan Designation:
Treatment of patients with invasive (malignant) brain and central
nervous system tumors lacking alpha 2,6 sialyltransferase.
Designation
4/4/2005 Sponsor and Address
Marketing Exclusivity Falk Center for Molecular Therapeutics
1801 Maple Avenue
Suite 4300
Evanston IL 60201
***************************************************************************************
Generic Name Approved Orphan Indication:
Human anti-CD30 monoclonal antibody

Trade Name:
Orphan Designation:
Treatment of Hodgkin's disease

Designation
9/27/2004 Sponsor and Address
Marketing Exclusivity Medarex, Inc.
519 Route 173 West
Bloomsbury NJ 08804

***************************************************************************************
Generic Name Approved Orphan Indication:
human anti-CD4 monoclonal antibody

Trade Name:
HuMax-CD4 Orphan Designation:
Treatment of mycosis fungoides

Designation
8/13/2004 Sponsor and Address
Marketing Exclusivity Genmab A/S
Tolbodgade 33
DK-1253 Copenhagen K

DENMARK
***************************************************************************************
Generic Name Approved Orphan Indication:
Human anti-integrin receptor av monoclonal
antibody
Trade Name:
Orphan Designation:
Treatment of patients with angiosarcoma

Designation
5/5/2005 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
human anti-integrin receptor avb3/avb5 monoclonal
antibody

Trade Name:
Orphan Designation:
Treatment of patients with high-risk stage II, stage III, and stage IV
malignant melanoma
Designation
12/1/2004 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
human anti-transforming growth factor beta 1
monoclonal antibody

Trade Name:
Orphan Designation:
Treatment of systemic sclerosis

Designation
1/11/2002 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
One Kendall Square
Cambridge MA 02139

***************************************************************************************
Generic Name Approved Orphan Indication:
human anti-transforming growth factor-B1,2,3

Trade Name:
Orphan Designation:
Treatment of idiopathic pulmonary fibrosis

Designation
7/9/2004 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
500 Kendall Street
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Human cytomegalovirus immunoglobulin

Trade Name:
Orphan Designation:
Prevention of congenital cytomegalovirus (CMV) infection following
primary CMV infection in pregnant women
Designation
12/20/2006 Sponsor and Address
Marketing Exclusivity Biotest Diagnostics Corporation
66 Ford Road
Denville NJ 07834

***************************************************************************************
Generic Name Approved Orphan Indication:
human gammaglobulin

Trade Name:
Orphan Designation:
Treatment of gastrointestinal disturbances (to include constipation,
diarrhea, and abdominal pain) associated with regression-onset
Designation autism in pediatric patients.
9/16/2002 Sponsor and Address
Marketing Exclusivity Protein Therapeutics, Inc.
70 Calle Encanto
Tucson AZ 85716

***************************************************************************************
Generic Name Approved Orphan Indication:
human gammaglobulin

Trade Name:
Orphan Designation:
Treatment of idiopathic inflammatory myopathies

Designation
11/14/2003 Sponsor and Address
Marketing Exclusivity Protein Therapeutics, Inc.
70 Calle Encanto
Tucson AZ 85716

***************************************************************************************
Generic Name Approved Orphan Indication:
human gammaglobulin

Trade Name:
Orphan Designation:
Treatment for juvenile rheumatoid arthritis

Designation
5/25/2001 Sponsor and Address
Marketing Exclusivity PediaMed Pharmaceuticals, Inc.
7310 Turfway Road
Suite 490
Florence KY 41042
***************************************************************************************
Generic Name Approved Orphan Indication:
Human IgM monoclonal antibody (C-58) To CMV

Trade Name:
Centovir Orphan Designation:
Prophylaxis of cytomegalovirus infections in bone marrow transplant
patients.
Designation
8/7/1989 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
244 Great Valley Parkway
Malvern PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Human IgM monoclonal antibody (C-58) To CMV

Trade Name:
Centovir Orphan Designation:
Treatment of cytomegalovirus infections in allogenic bone marrow
transplant patients.
Designation
8/7/1989 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
244 Great Valley Parkway
Malvern PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Human immune globulin

Trade Name:
Xepol Orphan Designation:
Treatment of post-polio syndrome

Designation
3/29/2006 Sponsor and Address
Marketing Exclusivity Pharmalink AB
P. O. Box 625

SWEDEN
***************************************************************************************
Generic Name Approved Orphan Indication:
Human immunodeficiency virus immune globulin

Trade Name:
Orphan Designation:
Treatment of AIDS.

Designation
11/21/1989 Sponsor and Address
Marketing Exclusivity NABI
5800 Park of Commerce Blvd., NW
Boca Raton FL 33487

***************************************************************************************
Generic Name Approved Orphan Indication:
Human immunodeficiency virus immune globulin

Trade Name:
Orphan Designation:
Treatment of HIV-infected pregnant women and infants of HIV-
infected mothers.
Designation
3/25/1992 Sponsor and Address
Marketing Exclusivity NABI
5800 Park of Commerce Blvd., N.W.
Boca Raton FL 33487

***************************************************************************************
Generic Name Approved Orphan Indication:
Human immunodeficiency virus immune globulin

Trade Name:
Hivig Orphan Designation:
Treatment of HIV-infected pediatric patients.

Designation
1/4/1995 Sponsor and Address
Marketing Exclusivity NABI
5800 Park of Commerce Blvd., NW
Boca Raton FL 33487

***************************************************************************************
Generic Name Approved Orphan Indication:
Human immunoglobin anti-CD30 monoclonal
antibody
Trade Name:
Orphan Designation:
Treatment of CD30+ T-cell lymphoma

Designation
1/10/2006 Sponsor and Address
Marketing Exclusivity Medarex, Inc.
519 Route 173 West
Bloomsbury NJ 08804

***************************************************************************************
Generic Name Approved Orphan Indication:
Human immunoglobulin (IgG1k)antiCTLA-4
monoclonal antibody

Trade Name:
Orphan Designation:
Treatment of high risk Stage II, Stage III, and Stage IV melanoma

Designation
6/3/2004 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Pharmaceutical Research Insti
5 Research Parkway
Signature 91 Bldg/3SIG-3012
Wallingford CT 06492
***************************************************************************************
Generic Name Approved Orphan Indication:
human leukocyte-derived cytokine mixture

Trade Name:
Orphan Designation:
For neoadjuvant therapy in pts. w/squamous cell carcinoma of the
head and neck
Designation
7/7/2005 Sponsor and Address
Marketing Exclusivity IRX Therapeutics, Inc.
140 West 57th Street
New York City NY 10019

***************************************************************************************
Generic Name Approved Orphan Indication:
Human monoclonal antibody against platelet-
derived growth factor D

Trade Name:
Orphan Designation:
To slow the progression of IgA nephropathy and delay kidney failure
in patients affected by the disease.
Designation
11/2/2004 Sponsor and Address
Marketing Exclusivity CuraGen Corporation
322 East Main Street
Branford CT 06405

***************************************************************************************
Generic Name Approved Orphan Indication:
Human monoclonal antibody directed against
serotype 011 Pseudomonas aeruginosa

Trade Name:
Aerumab 11 Orphan Designation:
Treatment of hospital acquired pneumonia caused by serotype 011
positive Pseudomonas aeruginosa
Designation
9/18/2006 Sponsor and Address
Marketing Exclusivity Kenta Biotech Limited
Rehhagstrsase

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
Human monoclonal antibody targeting CC-
chemokine ligand 2

Trade Name:
Orphan Designation:
Treatment of pancreatic cancer

Designation
10/24/2006 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
200 Great Valley PArkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
Human plasma coagulation Factor VIII and human
plasma von Willebrand Factor

Trade Name:
Wilate Orphan Designation:
Treatment of von Willebrand disease except for surgical and/or
invasive procedures in patients with von Willebrand disease in whom
Designation desmopressin is either ineffective or contraindicated
4/18/2007 Sponsor and Address
Marketing Exclusivity Octapharma USA, Inc.
5885 Trinity Parkway
Suite 350
Centreville VA 20120
***************************************************************************************
Generic Name Approved Orphan Indication:
Human telomerase reverse transcriptase peptide
vaccine
Trade Name:
Orphan Designation:
Treatment of pancreatic cancer

Designation
7/20/2006 Sponsor and Address
Marketing Exclusivity Pharmexa A/S
Koigle Alle 6

DENMARK
***************************************************************************************
Generic Name Approved Orphan Indication:
Human T-lymphotropic virus type III Gp160 antigens

Trade Name:
Vaxsyn HIV-1 Orphan Designation:
Treatment of AIDS.

Designation
11/20/1989 Sponsor and Address
Marketing Exclusivity MicroGeneSys, Inc.
1000 Research Parkway
Meriden CT 06450

***************************************************************************************
Generic Name Approved Orphan Indication:
Human umbilical tissue-derived cells

Trade Name:
Orphan Designation:
Treatment of retinitis pigmentosa

Designation
3/13/2006 Sponsor and Address
Marketing Exclusivity Centocor, Inc
200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
Humanized anti-CD3 monoclonal antibody

Trade Name:
Orphan Designation:
Treatment of recent-onset Type I diabetes

Designation
9/29/2006 Sponsor and Address
Marketing Exclusivity MacroGenics, Inc.
1500 East Gude Drive
Rockville MD 20850

***************************************************************************************
Generic Name Approved Orphan Indication:
humanized anti-human CD16 monoclonal antibody

Trade Name:
Orphan Designation:
Treatment of adult idiopathic thrombocytopenic purpura

Designation
3/21/2005 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
500 Kendall Street
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Humanized anti-human CD2 MAb

Trade Name:
MEDI-507 Orphan Designation:
For the induction of donor-specific immunologic unresponsiveness
resulting in prophylaxis of organ rejection without the need for
Designation chronic immunosuppressive therapy, in patients receiving allogeneic
9/17/1998 renal transplants.
Sponsor and Address
Marketing Exclusivity Biotransplant, Inc.
Building 75, 3rd. Ave.
Charlestown Navy Yard
Charlestown MA 02129
***************************************************************************************
Generic Name Approved Orphan Indication:
Humanized anti-tac

Trade Name:
Zenapax Orphan Designation:
Prevention of acute graft-vs-host disease following bone marrow
transplantation.
Designation
3/5/1993 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110-1199

***************************************************************************************
Generic Name Approved Orphan Indication:
Humanized MAb (IDEC-131) to CD40L

Trade Name:
Orphan Designation:
Treatment of systemic lupus erythematosus.

Designation
2/9/1999 Sponsor and Address
Marketing Exclusivity Biogen IdecInc.
3030 Callan Rd.
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
humanized monoclonal antibody against Shiga-like
toxin II
Trade Name:
Orphan Designation:
To prevent the development of or to decrease the incidence and
severity of hemolytic uremic syndrome and associated sequelae of
Designation Shiga-like toxin-producing E. coli.
9/12/2001 Sponsor and Address
Marketing Exclusivity Teijin America, Inc.
600 Alexander Park
Suite 304
Princeton NJ 08540
***************************************************************************************
Generic Name Approved Orphan Indication:
Humanized monoclonal antibody to the high affinity
folate alpha receptor

Trade Name:
Orphan Designation:
Treatment of ovarian cancer

Designation
6/16/2006 Sponsor and Address
Marketing Exclusivity Morphotek, Inc.
210 Welsh Pool Road
Exton PA 19341

***************************************************************************************
Generic Name Approved Orphan Indication:
hyaluronic acid

Trade Name:
Orphan Designation:
Treatment of emphysema in patients due to alpha-1 antitrypsin
deficiency
Designation
3/19/2002 Sponsor and Address
Marketing Exclusivity Exhale Therapeutics, Inc.
1301 Shoreway Road
Suite 320
Belmont CA 94002
***************************************************************************************
Generic Name Approved Orphan Indication:
Hydralazine

Trade Name:
Orphan Designation:
Treatment of severe intrapartum hypertension (diastolic blood
pressure greater than or equal to 110 or systolic blood pressure
Designation greater than or equal to 160) associated with severe
4/9/2004 Sponsor and Address preeclampsia/eclampsia of pregnancy
Marketing Exclusivity Barbeau Pharma, Inc.
790 W. Frontage Road
Suite 125
Northfield IL 60093
***************************************************************************************
Generic Name Approved Orphan Indication:
Hydroxocobalamin Treatment on known or suspected cyanide poisoning

Trade Name:
Cyanokit Orphan Designation:
Treatment of acute cyanide poisoning

Designation
11/25/2003 Sponsor and Address
Marketing Exclusivity Merck Sante, s.a.a.
12/15/2006 37 rue Saint Romain
69008 Lyon

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
Hydroxocobalamin

Trade Name:
Orphan Designation:
Treatment of acute cyanide poisoning

Designation
9/22/2000 Sponsor and Address
Marketing Exclusivity Jazz Pharmaceuticals
3180 Porter Drive
Palo Alto CA 94304

***************************************************************************************
Generic Name Approved Orphan Indication:
Hydroxycobalamin/sodium thiosulfate

Trade Name:
Orphan Designation:
Treatment of severe acute cyanide poisoning.

Designation
10/4/1985 Sponsor and Address
Marketing Exclusivity Hall, Alan H., M.D.
Mile 5.0 Pass Creek Road
PO Box 24
Elk Mountain WY 82324
***************************************************************************************
Generic Name Approved Orphan Indication:
hydroxyurea

Trade Name:
Orphan Designation:
Treatment of pediatric patients with sickle cell anemia.

Designation
4/15/2005 Sponsor and Address
Marketing Exclusivity UPM Pharmaceuticals, Inc.
6200 Seaforth Street
Baltimore MD 21224

***************************************************************************************
Generic Name Approved Orphan Indication:
Hydroxyurea To reduce the frequency of painful crises and to reduce the need for
blood transfusions in adult patients with sickle cell anemia with
recurrent moderate to severe painful crises (generally at least 3
Trade Name: during the preceding 12 months).
Droxia Orphan Designation:
Treatment of patients with sickle cell anemia as shown by the
presence of hemoglobin S.
Designation
10/1/1990 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Pharmaceutical Research Institute
2/25/1998 P.O. Box 4000
Princeton NJ 08543

***************************************************************************************
Generic Name Approved Orphan Indication:
Hypericin

Trade Name:
Orphan Designation:
Treatment of glioblastoma multiforme.

Designation
8/3/2000 Sponsor and Address
Marketing Exclusivity Nexell Therapeutics
2751 Centerville Rd., Suite 210
Wilmington DE 19808

***************************************************************************************
Generic Name Approved Orphan Indication:
Hypericin

Trade Name:
Orphan Designation:
Treatment of cutaneous T-cell lymphoma.

Designation
2/7/2000 Sponsor and Address
Marketing Exclusivity Nexell Therapeutics, Inc.
2751 Centerville Rd., Suite 210
Wilmington DE 19808

***************************************************************************************
Generic Name Approved Orphan Indication:
I(131)-TM-601 (chlorotoxin)

Trade Name:
Orphan Designation:
treatment of malignant glioma

Designation
2/14/2002 Sponsor and Address
Marketing Exclusivity TransMolecular, Inc.
840 Memorial Drive
Second Floor
Cambridge MA 02139
***************************************************************************************
Generic Name Approved Orphan Indication:
Iboctadekin

Trade Name:
Orphan Designation:
Treatment of renal cell carcinoma

Designation
6/3/2005 Sponsor and Address
Marketing Exclusivity SmithKlineBeecham Corporation
d/b/a GlaxoSmithKline
P. O. Box 7929
Philadelphia PA 19101
***************************************************************************************
Generic Name Approved Orphan Indication:
ibritumomab tiuxetan Treatment of patients with relapsed or refractory low-grade, follicular,
or transformed B-cell non-Hodgkin?s lymphoma, including patients
with Rituximab (Rituxan?) refractory follicular non-Hodgkin?s
Trade Name: lymphoma
Zevalin Orphan Designation:
Treatment of B-cell non-Hodgkin's lymphoma.

Designation
9/6/1994 Sponsor and Address
Marketing Exclusivity Biogen IDEC Inc.
2/19/2002 5200 research Place
San Diego CA 92122

***************************************************************************************
Generic Name Approved Orphan Indication:
Ibuprofen i.v. solution

Trade Name:
Salprofen Orphan Designation:
Prevention of patent ductus arteriosus.

Designation
10/29/1996 Sponsor and Address
Marketing Exclusivity Farmacon-IL, LLC
1720 Post Road East
Suite 213
Westport CT 06880-5643
***************************************************************************************
Generic Name Approved Orphan Indication:
Ibuprofen lysine For closure of a clinically significant patent ductus arteriosus in
premature infants weighing between 500 and 1500 g, who are no
more than 32 weeks gestational age when usual medical
Trade Name: management (e.g., fluid restriction, diuretics, respiratory support, etc.)
NeoProfen Orphan Designation:
Treatment of patent ductus arteriosus.

Designation
10/29/1996 Sponsor and Address
Marketing Exclusivity Farmacon-IL, LLC
4/13/2006 1720 Post Road East
Suite 213
Westport CT 06880-5643
***************************************************************************************
Generic Name Approved Orphan Indication:
Icatibant

Trade Name:
Orphan Designation:
Treatment of angioedema

Designation
11/25/2003 Sponsor and Address
Marketing Exclusivity Jerini AG
Invalidenstr. 130
10115 Berlin

GERMANY
***************************************************************************************
Generic Name Approved Orphan Indication:
Icatibant acetate

Trade Name:
Orphan Designation:
Treatment of burn patients hospitalized with burn-induced edema

Designation
5/5/2004 Sponsor and Address
Marketing Exclusivity Jerini AG
Invalidenstr, 130
10115 Berlin

GERMANY
***************************************************************************************
Generic Name Approved Orphan Indication:
Icodextrin 7.5% with Electrolytes Peritoneal Dialysis For use as a single daily exchange for the long (8-16 hour) dwell
Solution during continuous ambulatory peritoneal dialysis (CAPD) or
automated peritoneal dialysis (APD) for the management of chronic
renal failure.
Trade Name:
Extraneal (with 7.5% Icodextrin) Peritoneal Orphan Designation:
Dialysis Solutio Treatment of those patients having end stage renal disease and
requiring peritoneal dialysis treatment.
Designation
7/18/1997 Sponsor and Address
Marketing Exclusivity Baxter Healthcare Corporation
12/20/2002 Renal Division
1620 Waukegan Road
McGaw Park IL 60085
***************************************************************************************
Generic Name Approved Orphan Indication:
Idarubicin

Trade Name:
Idamycin Orphan Designation:
Treatment of chronic myelogenous leukemia.

Designation
12/2/1992 Sponsor and Address
Marketing Exclusivity Pharmacia & Upjohn
7000 Portage Road
Unit 0633-298-113
Kalamazoo MI 49001-0199
***************************************************************************************
Generic Name Approved Orphan Indication:
Idarubicin

Trade Name:
Idamycin Orphan Designation:
Treatment of myelodysplastic syndromes.

Designation
12/1/1992 Sponsor and Address
Marketing Exclusivity Pharmacia & Upjohn
7000 Portage Road
Unit 0633-298-113
Kalamazoo MI 49001-0199
***************************************************************************************
Generic Name Approved Orphan Indication:
Idarubicin HCl for injection

Trade Name:
Idamycin Orphan Designation:
Treatment of acute myelogenous leukemia, also referred to as acute
nonlymphocytic leukemia.
Designation
7/25/1988 Sponsor and Address
Marketing Exclusivity Adria Laboratories, Inc.
9/27/1990 P.O. Box 16529
Columbus OH 43216

***************************************************************************************
Generic Name Approved Orphan Indication:
Idarubicin HCl for injection

Trade Name:
Idamycin Orphan Designation:
Treatment of acute lymphoblastic leukemia in pediatric patients.

Designation
2/12/1991 Sponsor and Address
Marketing Exclusivity Pharmacia & Upjohn
7000 Portage Road
Unit 0633-298-113
Kalamazoo MI 49001-0199
***************************************************************************************
Generic Name Approved Orphan Indication:
idebenone

Trade Name:
Orphan Designation:
Treatment of Leber's hereditary optic neuropathy.

Designation
10/31/2006 Sponsor and Address
Marketing Exclusivity Santhera Pharmaceuticals Limited
Hammerstrasse 47

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
idebenone

Trade Name:
Orphan Designation:
Treatment of Duchenne muscular dystrophy

Designation
2/16/2007 Sponsor and Address
Marketing Exclusivity Santhera Pharaceuticals Limited
Hammerstrasse 47

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
Idebenone

Trade Name:
Orphan Designation:
Treatment of cardiomyopathy associated with Friedreich's ataxia

Designation
3/25/2004 Sponsor and Address
Marketing Exclusivity Santhera Pharmaceuticals LLC
Hammerstrasse 25
CH-4410 Liestal

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
Idoxuridine

Trade Name:
Orphan Designation:
Treatment of nonparenchymatous sarcomas.

Designation
4/8/1996 Sponsor and Address
Marketing Exclusivity NeoPharm, Inc.
225 East Deerpath, Suite 250
Lake Forest IL 60045

***************************************************************************************
Generic Name Approved Orphan Indication:
idursulfase Indicated for patients with Hunter syndrome (mucopolysaccharidosis
II, MPS II). Idursulfase has been shown to improve walking capacity
in these patients
Trade Name:
Elaprase Orphan Designation:
Long term enzyme replacement therapy for patients with
mucopolysaccharidosis II (Hunter Syndrome)
Designation
11/28/2001 Sponsor and Address
Marketing Exclusivity Shire Human Genetic Therapies, Inc.
7/24/2006 700 Main Street
Cambridge MA 02139

***************************************************************************************
Generic Name Approved Orphan Indication:
Ifosfamide In combination with certain other approved antineoplastic agents, for
third line chemotherapy in the treatment of germ cell testicular
cancer.
Trade Name:
Ifex Orphan Designation:
Treatment of testicular cancer.

Designation
1/20/1987 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Pharmaceutical Research Institute
12/30/1988 5 Research Parkway, P.O. Box 5100
Wallingford CT 06492

***************************************************************************************
Generic Name Approved Orphan Indication:
Ifosfamide

Trade Name:
Ifex Orphan Designation:
Treatment of bone sarcomas

Designation
8/7/1985 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Pharmaceutical Research Institute
P.O. Box 4000
Princeton NJ 08543-4000

***************************************************************************************
Generic Name Approved Orphan Indication:
Ifosfamide

Trade Name:
Ifex Orphan Designation:
Treatment of soft tissue sarcomas.

Designation
8/7/1985 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Pharmaceutical Research Institute
P.O. Box 4000
Princeton NJ 08543

***************************************************************************************
Generic Name Approved Orphan Indication:
IL13-PE38QQR

Trade Name:
Orphan Designation:
Treatment of malignant glioma

Designation
11/2/2001 Sponsor and Address
Marketing Exclusivity NeoPharm, Inc.
150 Field Drive
Suite 195
Lake Forest IL 60045
***************************************************************************************
Generic Name Approved Orphan Indication:
IL-4 Pseudomonas Toxin Fusion Protein (IL-4(38-37)-
PE38KDEL)

Trade Name:
Orphan Designation:
Treatment of astrocytic glioma.

Designation
4/6/2000 Sponsor and Address
Marketing Exclusivity Protox Therapeutics, Inc.
1210-885 West Georgia
Vancouver, British Columbia
San Diego
CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Iloprost inhalation solution Treatment of pulmonary arterial hypertension (WHO Group I) in
patients with NYHA Class III or IV symptoms

Trade Name:
Ventavis Orphan Designation:
Treatment of pulmonary arterial hypertension

Designation
8/17/2004 Sponsor and Address
Marketing Exclusivity CoTherix, Inc.
12/29/2004 5000 Shoreline Court
South San Francisco CA 94080

***************************************************************************************
Generic Name Approved Orphan Indication:
Iloprost solution for infusion

Trade Name:
Orphan Designation:
Treatment of Raynaud's phenomenon secondary to systemic sclerosis.

Designation
9/21/1989 Sponsor and Address
Marketing Exclusivity Berlex Laboratories, Inc.
300 Fairfield Road
Wayne NJ 07470

***************************************************************************************
Generic Name Approved Orphan Indication:
Iloprost solution for infusion

Trade Name:
Orphan Designation:
Treatment of heparin-associated thrombocytopenia.

Designation
5/14/1990 Sponsor and Address
Marketing Exclusivity Berlex Laboratories, Inc.
300 Fairfield Road
Wayne NJ 07470

***************************************************************************************
Generic Name Approved Orphan Indication:
Imatinib Treatment of patients with chronic myeloid
leukemia (CML) in blast crisis, accelerated phase, or in chronic phase
after failure of interferon-alpha therapy
Trade Name:
Gleevec Orphan Designation:
Treatment of chronic myelogenous leukemia

Designation
1/31/2001 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
5/10/2001 59 Route 10
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
Imatinib mesylate Treatment of adult patients with aggressive mastocytosis (ASM)
without the D816V c-Kit mutation or with c-Kit mutational status
unknown
Trade Name:
Gleevec Orphan Designation:
Treatment of systemic mastocytosis without the D816V c-kit mutation

Designation
9/9/2005 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
10/19/2006 One Health Plaza
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
Imatinib mesylate Treatment of adult patients with myelodysplastic/myeloproliferative
diseases (MDS/MPD) associated with PDGFR (platelet-derived growth
factor receptor) gene re-arrangements
Trade Name:
Gleevec Orphan Designation:
Treatment of myeloproliferative disorders/myelodysplastic syndromes
associated with platelet-derived growth factor gene re-arrangements
Designation
10/5/2005 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
10/19/2006 One Health Plaza
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
Imatinib mesylate Treatment of adult patients with hypereosinophic syndrome (HES)
and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-
PDGFRα fusion kinase (mutational analysis or FISH demonstration of
Trade Name: CHIC2 allele deletion) and for patients with HES and/or CEL who are
FIP1L1-PDGFRα fusion kinase negative or unknown
Gleevec Orphan Designation:
Treatment of idiopathic hypereosinophilic syndrome including acute
and chronic eosinophilic leukemia
Designation
8/25/2005 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
10/19/2006 One Health Plaza
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
imatinib mesylate Treatment of adult patients with relapsed or refractory Philadelphia
chromosome positive acute lymphoblastic leukemia (Ph+ALL)

Trade Name:
Gleevec Orphan Designation:
Treatment of Philadelphia-positive acute lymphoblastic leukemia

Designation
10/11/2005 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
10/19/2006 One Health Plaza
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
imatinib mesylate Treatment of adult patients with unresectable, recurrent and/or
metastatic dermatofibrosarcoma protuberans (DFSP)

Trade Name:
Gleevec Orphan Designation:
Treatment of dermatofibrosarcoma protuberans

Designation
12/19/2005 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
10/19/2006 One Health Plaza
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
imatinib mesylate Treatment of patients with Kit (CD117) positive unresectable and/or
metastatic malignant gastrointestinal stromal tumors (GIST)

Trade Name:
Gleevec Orphan Designation:
Treatment of gastrointestinal stromal tumors

Designation
11/1/2001 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corp.
2/1/2002 One Health Plaza
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
Imciromab pentetate

Trade Name:
Myoscint Orphan Designation:
Detecting early necrosis as an indication of rejection of orthotopic
cardiac transplants.
Designation
1/25/1989 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
244 Great Valley Parkway
Malvern PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
imexon

Trade Name:
Amplimexon Orphan Designation:
Treatment of ovarian cancer.

Designation
8/12/2005 Sponsor and Address
Marketing Exclusivity AmpliMed Corporation
4380 N. Campbell Ave.
Tucson AZ 85718

***************************************************************************************
Generic Name Approved Orphan Indication:
Imexon

Trade Name:
Orphan Designation:
Treatment of multiple myeloma.

Designation
11/8/1996 Sponsor and Address
Marketing Exclusivity AmpliMed Corporation
2321 Camino La Zorrela
Tucson AZ 85718

***************************************************************************************
Generic Name Approved Orphan Indication:
Imexon

Trade Name:
Orphan Designation:
Treatment of pancreatic adenocarcinoma

Designation
11/1/2003 Sponsor and Address
Marketing Exclusivity AmpliMed Corporation
2321 Camino La Zorrela
Tucson AZ 85718

***************************************************************************************
Generic Name Approved Orphan Indication:
Imexon

Trade Name:
Orphan Designation:
Treatment of metastatic malignant melanoma

Designation
8/3/2001 Sponsor and Address
Marketing Exclusivity AmpliMed Corporation
2321 Camino La Zorrela
Tucson AZ 85718

***************************************************************************************
Generic Name Approved Orphan Indication:
Imiglucerase Enzyme replacement therapy in patients with type I Gaucher's
disease.

Trade Name:
Cerezyme Orphan Designation:
Replacement therapy in patients with types I, II, and III Gaucher's
disease.
Designation
11/5/1991 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
5/23/1994 One Kendall Square
Cambridge MA 02139-1562

***************************************************************************************
Generic Name Approved Orphan Indication:
Immortalized human liver cells found in the
extracorporeal liver assist device

Trade Name:
ELAD Orphan Designation:
Treatment of fulminant hepatic failure (acute liver failure)

Designation
7/16/2004 Sponsor and Address
Marketing Exclusivity Vital Therapies, Inc.
15222 Avenue of Science
Suite C
San Diego CA 92128
***************************************************************************************
Generic Name Approved Orphan Indication:
Immune Globulin (Human)

Trade Name:
Gamunex Orphan Designation:
Treatment of chronic inflammatory demyelinating polyneuropathy

Designation
7/27/2004 Sponsor and Address
Marketing Exclusivity Talecris
8368 US 70 West
Clayton NC 27520

***************************************************************************************
Generic Name Approved Orphan Indication:
Immune Globulin (Human) containing high titers of
West Nile virus antibodies

Trade Name:
Omr-IgG-am (tm) 5% (WNV) Orphan Designation:
Treatment of the West Nile virus infection

Designation
3/17/2004 Sponsor and Address
Marketing Exclusivity OMRIX Biopharmaceuticals, Ltd.
Plasma Fractionation Institute
Ramat Gan 52621

ISRAEL
***************************************************************************************
Generic Name Approved Orphan Indication:
Immune Globulin Intravenous (human)

Trade Name:
Carimune NF Orphan Designation:
Treatment for Guillain Barre Syndrome

Designation
5/4/2004 Sponsor and Address
Marketing Exclusivity ZLB Bioplasma AG
Wankdorfstrasse 10
CH-3000 Bern 22

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
Immune globulin intravenous (human)

Trade Name:
Gammagard Liquid Orphan Designation:
Treatment of multifocal motor neuropathy

Designation
7/20/2006 Sponsor and Address
Marketing Exclusivity Baxter Healthcare Corporation,
Baxter Bioscience
Westlake Village CA 91362

***************************************************************************************
Generic Name Approved Orphan Indication:
Immune globulin intravenous (human)

Trade Name:
Immune Globulin Intravenous (human) Immuno, Orphan Designation:
Iveegam Treatment of patients with acute myocarditis.

Designation
11/22/1993 Sponsor and Address
Marketing Exclusivity Immuno Clinical Research Corp.
750 Lexington Avenue
New York NY 10022

***************************************************************************************
Generic Name Approved Orphan Indication:
Immune globulin intravenous (human)

Trade Name:
Iveegam, Immuno Orphan Designation:
Treatment of polymyositis/dermatomyositis.

Designation
10/13/1992 Sponsor and Address
Marketing Exclusivity Immuno Clinical Research Corp.
155 East 56th Street
New York NY 10022

***************************************************************************************
Generic Name Approved Orphan Indication:
Immune globulin intravenous (human)

Trade Name:
Iveegam, Immuno Orphan Designation:
Treatment of juvenile rheumatoid arthritis.

Designation
12/16/1992 Sponsor and Address
Marketing Exclusivity Immuno Clinical Research Corp.
750 Lexington Avenue, 19th Floor
New York NY 10022

***************************************************************************************
Generic Name Approved Orphan Indication:
Immune globulin intravenous, human For prophylaxis of children with clinical or immunologic evidence of
human immunodeficiency virus to decrease the frequency of serious
and minor bacterial infections and the frequency of hospitalization,
Trade Name: and to increase the time free of serious bacterial infections.
Gamimune N Orphan Designation:
Infection prophylaxis in pediatric patients affected with the human
immunodeficiency virus.
Designation
2/18/1993 Sponsor and Address
Marketing Exclusivity Bayer Corporation
12/27/1993 Pharmaceutical Division, Biological Products
400 Morgan Lane
New Haven CT 06516
***************************************************************************************
Generic Name Approved Orphan Indication:
Immune Globulin Subcutaneous (Human)

Trade Name:
Vivaglobin P (proposed) Orphan Designation:
Treatment of patients with primary immune deficiency (PID) that are
intolerant to immune globulin intravenous (IGIV) due to severe
Designation adverse events or poor venous access
9/22/2004 Sponsor and Address
Marketing Exclusivity Aventis Behring, L.L.C.
1020 First Avenue
P.O. Box 61501
King of Prussia PA 19406-0901
***************************************************************************************
Generic Name Approved Orphan Indication:
Implitapide

Trade Name:
Orphan Designation:
Treatment of homozygous familial hypercholesterolemia

Designation
8/13/2004 Sponsor and Address
Marketing Exclusivity Medical Research Laboratories International
2 Tesseneer Drive
Highland Heights KY 41076

***************************************************************************************
Generic Name Approved Orphan Indication:
Imported fire ant venom, allergenic extract

Trade Name:
Orphan Designation:
For skin testing of victims of fire ant stings to confirm fire ant
sensitivity and if positive, for use as immunotherapy for the
Designation prevention of IgE-mediated anaphylactic reactions.
5/12/1992 Sponsor and Address
Marketing Exclusivity ALK Laboratories, Inc.
Research Center
27 Village Lane
Wallingford CT 06492
***************************************************************************************
Generic Name Approved Orphan Indication:
Inalimarev and falimarev

Trade Name:
Orphan Designation:
Treatment of adenocarcinoma of the pancreas

Designation
1/10/2006 Sponsor and Address
Marketing Exclusivity Therion Biologics Corporation
76 Rogers Street
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Indium In 111 murine monoclonal antibody FAB to
myosin
Trade Name:
Myoscint Orphan Designation:
To aid in the diagnosis of myocarditis.

Designation
8/7/1989 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
244 Great Valley Parkway
Malvern PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Indium In-111 altumomab pentetate

Trade Name:
Hybri-ceaker Orphan Designation:
Detection of suspected and previously unidentified tumor foci of
recurrent colorectal carcinoma.
Designation
2/6/1990 Sponsor and Address
Marketing Exclusivity Hybritech, Inc.
11095 Torreyanna Road
San Diego CA 92196

***************************************************************************************
Generic Name Approved Orphan Indication:
Indium-111 pentetreotide

Trade Name:
NeuroendoMedix Orphan Designation:
Treatment of neuroendocrine tumors

Designation
6/16/2006 Sponsor and Address
Marketing Exclusivity RadioIsotope Therapy of America (RITA) Foundation
9701 Richmond Avenue
Houston TX 77042

***************************************************************************************
Generic Name Approved Orphan Indication:
infliximab

Trade Name:
Remicade Orphan Designation:
Treatment of juvenile rheumatoid arthritis

Designation
10/23/2002 Sponsor and Address
Marketing Exclusivity Centocor, Inc.

200 Great Valley Parkway


Malvern PA 19355-1307
***************************************************************************************
Generic Name Approved Orphan Indication:
infliximab

Trade Name:
Remicade Orphan Designation:
Treatment of giant cell arteritis

Designation
5/6/2003 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
Infliximab

Trade Name:
REMICADE Orphan Designation:
Treatment of pediatric (0 to 16 years of age) ulcerative colitis

Designation
11/12/2003 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
Infliximab For reducing signs and symptoms and inducing and maintaining
clinical remission in pediatric patients with moderately to severely
active Crohn's disease who have had an inadequate response to
Trade Name: conventional therapy
REMICADE Orphan Designation:
Treatment of pediatric (0 to 16 years of age) Crohn's Disease

Designation
11/12/2003 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
5/19/2006 200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
Infliximab

Trade Name:
Remicade Orphan Designation:
Treatment of chronic sarcoidosis

Designation
5/21/2003 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
Infliximab Treatment of moderately to severely active Crohn's disease for the
reduction of the signs and symptoms, in patients who have an
inadequate response to conventional therapies; and treatment of
Trade Name: patients with fistulizing Crohn's disease for the reduction in the
number of draining enterocutaneous fistula(s).
Remicade Orphan Designation:
Treatment of moderately to severely active Crohn's disease for the
reduction of the signs and symptoms, in patients who have an
Designation inadequate response to conventional therapy; and treatment of
11/14/1995 patients with fistulizing Crohn's disease for the reduction in the
number of draining enterocutaneous fistula(s).
Sponsor and Address
Marketing Exclusivity Centocor, Inc.
8/24/1998 200 Great Valley Parkway
Malvern PA 19355-1307

***************************************************************************************
Generic Name Approved Orphan Indication:
INGN 201

Trade Name:
ADVEXIN Orphan Designation:
Treatment of head and neck cancer

Designation
1/27/2003 Sponsor and Address
Marketing Exclusivity Introgen Therapeutics, Inc.

2250 Holcombe Blvd


Houston TX 77030
***************************************************************************************
Generic Name Approved Orphan Indication:
INH-A00021

Trade Name:
Veronate Orphan Designation:
Reduction (prevention) of nosocomial bacteremia caused by
staphylococci in very low birth weight infants.
Designation
6/13/2001 Sponsor and Address
Marketing Exclusivity Inhibitex, Inc.
8995 Westside Parkway
Suite 150
Alpharetta GA 30004
***************************************************************************************
Generic Name Approved Orphan Indication:
inolimomab

Trade Name:
Leukotac Orphan Designation:
Treatment of graft versus host disease

Designation
10/23/2002 Sponsor and Address
Marketing Exclusivity OPi
3, allee des sequoias*
69760 LIMONEST - France

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
Inosine pranobex

Trade Name:
Isoprinosine Orphan Designation:
Treatment of subacute sclerosing panencephalitis.

Designation
9/20/1988 Sponsor and Address
Marketing Exclusivity Newport Pharmaceuticals
897 West Sixteenth Street
Newport Beach CA 92663

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2a Treatment of chronic myelogenous leukemia.

Trade Name:
Roferon A Orphan Designation:
Treatment of chronic myelogenous leukemia.

Designation
6/6/1989 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
10/19/1995 340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2a (recombinant)

Trade Name:
Roferon-A Orphan Designation:
Treatment of renal cell carcinoma.

Designation
4/18/1988 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110-1199

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2a (recombinant)

Trade Name:
Roferon-A Orphan Designation:
For the treatment of metastatic malignant melanoma in combination
with Teceleukin.
Designation
5/11/1990 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2a (recombinant)

Trade Name:
Roferon-A Orphan Designation:
For the concomitant administration with Teceleukin for the treatment
of metastatic renal cell carcinoma.
Designation
5/2/1990 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07119

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2a (recombinant)

Trade Name:
Roferon-A Orphan Designation:
Treatment of AIDS related Kaposi's sarcoma.

Designation
12/14/1987 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
11/21/1988 340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2a (recombinant)

Trade Name:
Roferon-A Orphan Designation:
For the concomitant administration with fluorouracil for the treatment
of advanced colorectal cancer.
Designation
5/14/1990 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110-1199

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2a (recombinant)

Trade Name:
Roferon-A Orphan Designation:
For use in combination with fluorouracil for the treatment of
esophageal carcinoma.
Designation
10/27/1989 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110-1199

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2b (recombinant) Treatment of selected patients with AIDS-related Kaposi's sarcoma.

Trade Name:
Intron A Orphan Designation:
Treatment of AIDS-related Kaposi's sarcoma.

Designation
6/24/1987 Sponsor and Address
Marketing Exclusivity Schering Corporation
11/21/1988 2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2b (recombinant)

Trade Name:
Intron A Orphan Designation:
Treatment of acute hepatitis B.

Designation
11/17/1988 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2b (recombinant)

Trade Name:
Intron A Orphan Designation:
Treatment of primary malignant brain tumors.

Designation
5/13/1988 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2b (recombinant)

Trade Name:
Intron A Orphan Designation:
Treatment of carcinoma in situ of the urinary bladder.

Designation
8/10/1988 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2b (recombinant)

Trade Name:
Intron A Orphan Designation:
Treatment of invasive carcinoma of the cervix.

Designation
4/18/1988 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2b (recombinant)

Trade Name:
Intron A Orphan Designation:
Treatment of ovarian carcinoma.

Designation
8/3/1987 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2b (recombinant)

Trade Name:
Intron A Orphan Designation:
Treatment of chronic myelogenous leukemia.

Designation
6/22/1987 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2b (recombinant)

Trade Name:
Intron A Orphan Designation:
Treatment of metastatic renal cell carcinoma.

Designation
6/22/1987 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2b (recombinant)

Trade Name:
Intron A Orphan Designation:
Treatment of laryngeal (respiratory) papillomatosis.

Designation
8/17/1988 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-2b (recombinant)

Trade Name:
Intron A Orphan Designation:
Treatment of chronic delta hepatitis.

Designation
5/4/1990 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-nl

Trade Name:
Wellferon Orphan Designation:
Treatment of human papillomavirus in patients with severe
resistant/recurrent respiratory (laryngeal) papillomatosis.
Designation
10/16/1987 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Inc.
5 Moore Drive
Research Triangle Park NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon alfa-nl

Trade Name:
Wellferon Orphan Designation:
Treatment of AIDS related Kaposi's sarcoma.

Designation
8/25/1986 Sponsor and Address
Marketing Exclusivity Burroughs Wellcome Company
3030 Cornwallis Road
Research Triangle Pk NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon beta (recombinant)

Trade Name:
R-IFN-beta Orphan Designation:
For the systemic treatment of metastatic renal cell carcinoma.

Designation
2/12/1991 Sponsor and Address
Marketing Exclusivity Biogen, Inc.
14 Cambridge Center
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon beta (recombinant)

Trade Name:
r-HuIFN-beta Orphan Designation:
For the intralesional and/or systemic treatment of AIDS-related
Kaposi's sarcoma.
Designation
5/9/1991 Sponsor and Address
Marketing Exclusivity Biogen, Inc.
14 Cambridge Center
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon beta (recombinant)

Trade Name:
r-HuIFN-beta Orphan Designation:
For the systemic treatment of cutaneous T-cell lymphoma.

Designation
4/18/1991 Sponsor and Address
Marketing Exclusivity Biogen, Inc.
14 Cambridge Center
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon beta, recombinant human

Trade Name:
Betaseron Orphan Designation:
Treatment of acquired immunodeficiency syndrome.

Designation
11/15/1988 Sponsor and Address
Marketing Exclusivity Berlex Laboratories, Inc.
15049 San Pablo Avenue, P.O. Box 4099
Richmond CA 94804

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon beta-1a

Trade Name:
Rebif Orphan Designation:
Treatment of patients with secondary progressive multiple sclerosis.

Designation
3/11/1996 Sponsor and Address
Marketing Exclusivity Serono Laboratories, Inc.
100 Longwater Circle
Norwell MA 02061

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon beta-1a Treatment of relapsing forms of multiple sclerosis to slow the
accumulation of physical disability and decrease the frequency of
clinical exacerbations.
Trade Name:
Avonex Orphan Designation:
Treatment of multiple sclerosis.

Designation
12/16/1991 Sponsor and Address
Marketing Exclusivity Biogen, Inc.
5/17/1996 14 Cambridge Center
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon beta-1a (recombinant human)

Trade Name:
Orphan Designation:
Treatment of acute non-A, non-B hepatitis.

Designation
7/24/1992 Sponsor and Address
Marketing Exclusivity Biogen, Inc.
14 Cambridge Center
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon beta-1a (recombinant)

Trade Name:
r-HuIFN-beta Orphan Designation:
For the systemic treatment of cutaneous malignant melanoma.

Designation
4/3/1991 Sponsor and Address
Marketing Exclusivity Biogen, Inc.
14 Cambridge Center
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon beta-1a (recombinant)

Trade Name:
Rebif Orphan Designation:
Treatment of symptomatic patients with AIDS including all patients
with CD4 T-cell counts less than 200 cells per mm3.
Designation
12/2/1992 Sponsor and Address
Marketing Exclusivity Serono Laboratories, Inc.
100 Longwater Circle
Norwell MA 02061

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon beta-1b In ambulatory patients with relapsing-remitting multiple sclerosis to
reduce the frequency of clinical exacerbations.

Trade Name:
Betaseron Orphan Designation:
Treatment of multiple sclerosis.

Designation
11/17/1988 Sponsor and Address
Marketing Exclusivity Chiron Corp. & Berlex Laboratories
7/23/1993 4560 Horton Street
Emeryville CA 94608

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon gamma 1-b

Trade Name:
Actimmune Orphan Designation:
Treatment of chronic granulomatous disease.

Designation
9/30/1988 Sponsor and Address
Marketing Exclusivity InterMune, Inc.
12/20/1990 3280 Bayshore Blvd
Brisbane CA 94005

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon gamma-1b Delaying time to disease progression in patients with severe,
malignant osteopetrosis.

Trade Name:
Actimmune Orphan Designation:
Delaying time to disease progression in patients with severe,
malignant osteopetrosis.
Designation
9/30/1996 Sponsor and Address
Marketing Exclusivity InterMune , Inc.
2/10/2000 1710 Gilbreth Road,
Suite 301
Burlingame CA 94010-1317
***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon gamma-1b

Trade Name:
Actimmune Orphan Designation:
Treatment of renal cell carcinoma.

Designation
12/4/1995 Sponsor and Address
Marketing Exclusivity Genentech, Inc.
1 DNA Way
South San Francisco CA 94080-4990

***************************************************************************************
Generic Name Approved Orphan Indication:
Interferon-alfa-1b

Trade Name:
Orphan Designation:
Treatment of multiple myeloma

Designation
4/17/2001 Sponsor and Address
Marketing Exclusivity Ernest C.Borden
Center for Cancer Drud Discovery and Development
9500 Euclid Avenue
Clevland OH 44195
***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-1 alpha, human recombinant

Trade Name:
Orphan Designation:
For hematopoietic potentiation in aplastic anemia.

Designation
6/17/1991 Sponsor and Address
Marketing Exclusivity Immunex Corporation
51 University Street
Seattle WA 98101

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-1 alpha, human recombinant

Trade Name:
Orphan Designation:
For the promotion of early engraftment in bone marrow
transplantation.
Designation
6/17/1991 Sponsor and Address
Marketing Exclusivity Immunex Corporation
51 University Street
Seattle WA 98101

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-1 receptor antagonist, human
recombinant
Trade Name:
Antril Orphan Designation:
Treatment of juvenile rheumatoid arthritis.

Designation
9/23/1991 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
One Amgen Center Drive
Thousand Oaks CA 91320-1799

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-1 receptor antagonist, human
recombinant
Trade Name:
Antril Orphan Designation:
Prevention and treatment of graft versus host disease in transplant
recipients.
Designation
10/16/1992 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
One Amgen Center Drive
Thousand Oaks CA 91320-1799

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-1 Trap

Trade Name:
Orphan Designation:
Treatment of Still's disease including juvenile rheumatoid arthritis
and adult-onset Still's disease
Designation
4/4/2005 Sponsor and Address
Marketing Exclusivity Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown NY 10591

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-1Trap

Trade Name:
Orphan Designation:
Treatment of CIAS1-Associated Periodic Syndromes

Designation
12/20/2004 Sponsor and Address
Marketing Exclusivity Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown NY 10591

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-2

Trade Name:
Teceleukin Orphan Designation:
In combination with interferon alfa-2a for the treatment of metastatic
malignant melanoma.
Designation
5/11/1990 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-2

Trade Name:
Teleleukin Orphan Designation:
Treatment of metastatic malignant melanoma.

Designation
2/6/1990 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-2

Trade Name:
Teceleukin Orphan Designation:
Treatment of metastatic renal cell carcinoma.

Designation
2/5/1990 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-2

Trade Name:
Teceleukin Orphan Designation:
In combination with interferon alfa-2a for the treatment of metastatic
renal cell carcinoma.
Designation
5/3/1990 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-3 human (recombinant)

Trade Name:
Orphan Designation:
Promotion of erythropoiesis in Diamond-Blackfan anemia (congenital
pure red cell aplasia).
Designation
5/20/1991 Sponsor and Address
Marketing Exclusivity Immunex Corporation
51 University Street
Seattle WA 98101

***************************************************************************************
Generic Name Approved Orphan Indication:
Interleukin-3, human, recombinant

Trade Name:
Orphan Designation:
For sequential administration with sargramostim to accelerate
neutrophil and platelet recovery in patients undergoing autologous
Designation bone marrow transplantation for the treatment of Hodgkin's disease or
9/30/1993 non-Hodgkin's lymphoma.
Sponsor and Address
Marketing Exclusivity Sandoz Pharmaceuticals Corp.
59 Route 10
East Hanover NJ 07936

***************************************************************************************
Generic Name Approved Orphan Indication:
Intraoral fluoride releasing system

Trade Name:
IFRS Orphan Designation:
Prevention of dental caries due to radiation-induced xerostomia in
patients with head and neck cancer
Designation
7/31/2001 Sponsor and Address
Marketing Exclusivity Digestive Care, Inc.
1120 Win Drive
Bethlehem PA 18017

***************************************************************************************
Generic Name Approved Orphan Indication:
Intravenous immune globulin

Trade Name:
VitiGam Orphan Designation:
Treatment of Stage IIB to IV malignant melanoma

Designation
7/26/2007 Sponsor and Address
Marketing Exclusivity GammaCan Ltd.
39 Jerusalem Street

ISRAEL
***************************************************************************************
Generic Name Approved Orphan Indication:
Iobenguane I 123

Trade Name:
Orphan Designation:
For the diagnosis of pheochromocytoma.

Designation
12/1/2006 Sponsor and Address
Marketing Exclusivity GE Healthcare, Inc.
101 Carnegie Center
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Iobenguane I 123

Trade Name:
Orphan Designation:
For the diagnosis of neuroblastomas.

Designation
12/1/2006 Sponsor and Address
Marketing Exclusivity GE Healthcare, INc.
101 Carnegie Center
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
iobenguane I 131

Trade Name:
Orphan Designation:
Treatment of neuroendocrine tumors

Designation
7/5/2007 Sponsor and Address
Marketing Exclusivity DraxImage
Div. of Draxis Specialty Pharmaceuticals, Inc.
Kirkland, Quebec H9H 4J4

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Iobenguane I 131

Trade Name:
Ultratrace Orphan Designation:
Treatment of neuroendocrine tumors

Designation
1/18/2006 Sponsor and Address
Marketing Exclusivity Molecular Insight Pharmaceuticals
160 Second street
Cambridge MA 02142

***************************************************************************************
Generic Name Approved Orphan Indication:
Iobenguane Sulfate I 131 Adjunctive diagnostic agent in the localization of primary or
metastatic pheochromocytomas.

Trade Name:
Orphan Designation:
For use as a diagnostic adjunct in patients with pheochromocytoma.

Designation
11/14/1984 Sponsor and Address
Marketing Exclusivity University of Michigan
3/21/1990 UH B1 H410/0028
1500 E. Medical Center Drive
Ann Arbor MI 48109-0028
***************************************************************************************
Generic Name Approved Orphan Indication:
Iobenguane Sulfate I-123

Trade Name:
OmaClear Orphan Designation:
For scintigraphic detection, localization and staging of
neuroblastoma.
Designation
10/17/2005 Sponsor and Address
Marketing Exclusivity Brogan Pharmaceuticals, LLC
312 Lacebark Street
Schererville IN 46375

***************************************************************************************
Generic Name Approved Orphan Indication:
iobenguane sulfate I-123

Trade Name:
OmaClear Orphan Designation:
For the detection, localization, and staging of pheochromocytomas.

Designation
10/21/2005 Sponsor and Address
Marketing Exclusivity Brogan Pharmaceuticals, LLC
312 Lacebark Street
Schererville IN 46375

***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine 131 6B-iodomethyl-19-norcholesterol

Trade Name:
Orphan Designation:
For use in adrenal cortical imaging.

Designation
8/1/1984 Sponsor and Address
Marketing Exclusivity David E. Kuhl, M.D.
University of Michigan Medical Center/1500 E. Med.
B1G412 /0028 University Hospital
Ann Arbor MI 48109-0028
***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine I 123 murine monoclonal antibody to alpha-
fetoprotein

Trade Name:
Orphan Designation:
Detection of alpha-fetoprotein producing germ cell tumors.

Designation
9/30/1988 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine I 123 murine monoclonal antibody to alpha-
fetoprotein

Trade Name:
Orphan Designation:
Detection of hepatocellular carcinoma and hepatoblastoma.

Designation
9/30/1988 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine I 123 murine monoclonal antibody to hCG

Trade Name:
Orphan Designation:
Detection of hCG producing tumors such as germ cell and
trophoblastic cell tumors.
Designation
11/7/1988 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine I 131 bis(indium-
diethylenetriaminepentaacetic
acid)tyrosyllysine/hMN-14 x m734 F(ab')2 bispecific

Trade Name:
Pentacea Orphan Designation:
Treatment of small-cell lung cancer.

Designation
2/22/2000 Sponsor and Address
Marketing Exclusivity IBC Pharmaceuticals, L.L.C.
300 American Rd.
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine I 131 Lym-1 Monoclonal Antibody

Trade Name:
Orphan Designation:
Treatment of B-cell lymphoma.

Designation
11/2/1987 Sponsor and Address
Marketing Exclusivity Lederle Laboratories Division
American Cyanamide Company
401 N. Middletown Road
Pearl River NY 10965
***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine I 131 murine monoclonal antibody IgG2a to B
cell
Trade Name:
Immurait, Ll-2-I-131 Orphan Designation:
Treatment of B-cell leukemia and B-cell lymphoma.

Designation
9/18/1989 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine I 131 murine monoclonal antibody to alpha-
fetoprotein

Trade Name:
Orphan Designation:
Treatment of alpha-fetoprotein producing germ cell tumors.

Designation
9/30/1988 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine I 131 murine monoclonal antibody to alpha-
fetoprotein

Trade Name:
Orphan Designation:
Treatment of hepatocellular carcinoma and hepatoblastoma.

Designation
9/30/1988 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine I 131 murine monoclonal antibody to hCG

Trade Name:
Orphan Designation:
Treatment of hCG producing tumors such as germ cell and
trophoblastic cell tumors.
Designation
11/7/1988 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Iodine I-131 radiolabeled chimeric MAb tumor
necrosis treatment (TNT-1B)

Trade Name:
131IchTNT-1 Orphan Designation:
Treatment of glioblastoma multiforme and anaplastic astrocytoma.

Designation
2/12/1999 Sponsor and Address
Marketing Exclusivity Peregrine Pharmaceuticals, Inc.
14282 Franklin Ave.
Tustin CA 92780-7017

***************************************************************************************
Generic Name Approved Orphan Indication:
irofulven

Trade Name:
Orphan Designation:
Treatment of renal cell carcinoma.

Designation
7/27/1999 Sponsor and Address
Marketing Exclusivity MGI Pharma, Inc.
5775 West Old Shakoppe Rd.
Suite 100
Bloomington MN 55437-3107
***************************************************************************************
Generic Name Approved Orphan Indication:
irofulven

Trade Name:
Orphan Designation:
Treatment of ovarian cancer.

Designation
7/6/1999 Sponsor and Address
Marketing Exclusivity MGI Pharma, Inc.
5775 West Old Shakoppe Rd.
Suite 100
Bloomington MN 55437-3107
***************************************************************************************
Generic Name Approved Orphan Indication:
iron(III)-hexacyanoferrate(II) Treatment of patients with known or suspected internal contamination
with radioactive cesium and/or radioactive or non-radioactive
thallium to increase their rates of elimination
Trade Name:
Radiogardase Orphan Designation:
Treatment of patients with known or suspected internal contamination
with radioactive or non-radioactive cesium or thallium
Designation
5/1/2003 Sponsor and Address
Marketing Exclusivity Heyl Chemisch-Pharmzeutische Fabrik GMBH & Co, KG
10/2/2003 Goerzallee 253
D-14167 Berlin, Federal Republic of Germany

***************************************************************************************
Generic Name Approved Orphan Indication:
Isobutyramide

Trade Name:
Orphan Designation:
Treatment of sickle cell disease and beta thalassemia.

Designation
5/25/1994 Sponsor and Address
Marketing Exclusivity Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles CA 90032

***************************************************************************************
Generic Name Approved Orphan Indication:
Isobutyramide

Trade Name:
Isobutyramide oral solution Orphan Designation:
Treatment of beta-hemoglobinopathies and beta-thalassemia
syndromes.
Designation
12/18/1992 Sponsor and Address
Marketing Exclusivity Perrine, Susan P., M.D.
Boston University
Cancer Research Center
Boston MA 02118
***************************************************************************************
Generic Name Approved Orphan Indication:
Isofagomine tartrate

Trade Name:
Orphan Designation:
Treatment of Gaucher disease

Designation
1/10/2006 Sponsor and Address
Marketing Exclusivity Amicus Therapeutics, Inc.
6 Cedar Brook Drive
Cranbury NJ 08512

***************************************************************************************
Generic Name Approved Orphan Indication:
Japanese encephalitis vaccine (live, attenuated)

Trade Name:
Orphan Designation:
Prevention of Japanese encephalitis.

Designation
5/19/1999 Sponsor and Address
Marketing Exclusivity Glovax Co., Ltd.
Room 307, Koryo Academytel, 437-3
Ahyun-Dong, Mapo-Gu, Seoul 121-010

***************************************************************************************
Generic Name Approved Orphan Indication:
Ketoconazole

Trade Name:
Nizoral Orphan Designation:
For use with cyclosporine A to diminish the nephrotoxicity induced by
cyclosporine in organ transplantation.
Designation
3/27/1991 Sponsor and Address
Marketing Exclusivity Pharmedic Company
28101 Ballard Road
Lake Forest IL 60045

***************************************************************************************
Generic Name Approved Orphan Indication:
L-2-oxothiazolidine-4-carboxylic acid

Trade Name:
Procysteine Orphan Designation:
Treatment of adult respiratory distress syndrome.

Designation
6/14/1994 Sponsor and Address
Marketing Exclusivity Transcend Therapeutics, Inc.
640 Memorial Drive, 3rd Floor West
Cambridge MA 02139

***************************************************************************************
Generic Name Approved Orphan Indication:
L-2-oxothiazolidine-4-carboxylic acid

Trade Name:
Procysteine Orphan Designation:
Treatment of amyotrophic lateral sclerosis.

Designation
7/30/1996 Sponsor and Address
Marketing Exclusivity Transcend Therapeutics, Inc.
640 Memorial Drive, 3rd Floor West
Cambridge MA 02139

***************************************************************************************
Generic Name Approved Orphan Indication:
L-5-hydroxytryptophan

Trade Name:
Orphan Designation:
Treatment of tetrahydrobiopterin deficiency.

Designation
1/20/1999 Sponsor and Address
Marketing Exclusivity Watson Laboratories, Inc.
311 Bonnie Circle
P.O. Box 1900
Corona CA 91718-1900
***************************************************************************************
Generic Name Approved Orphan Indication:
Lactic acid

Trade Name:
Aphthaid Orphan Designation:
Treatment of severe aphthous stomatitis in severely, terminally
immunocompromised patients.
Designation
6/29/1999 Sponsor and Address
Marketing Exclusivity Frontier Pharmaceutical, Inc.
SUNY Farmingdale
Conklin Hall
Farmingdale NY 11735
***************************************************************************************
Generic Name Approved Orphan Indication:
lactic acid bacteria (Lactobacilli, Bifidobacteria, and
Steptococci)

Trade Name:
Orphan Designation:
Treatment of active chronic pouchitis

Designation
1/15/2002 Sponsor and Address
Marketing Exclusivity VSL Pharmaceuticals, Inc.
800 S. Frederick Avenue
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
lactic acid bacteria (Lactobacilli, Bifidobacteria, and
Streptococcus species)

Trade Name:
Orphan Designation:
Prevention of disease relapse in patients with chronic pouchitis

Designation
1/15/2002 Sponsor and Address
Marketing Exclusivity VSL Pharmaceuticals, Inc.
800 S. Frederick Ave.
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Lactobin

Trade Name:
Lactobin Orphan Designation:
Treatment of AIDS-associated diarrhea unresponsive to initial
antidiarrheal therapy.
Designation
9/12/1990 Sponsor and Address
Marketing Exclusivity Roxane Laboratories, Inc.
P.O. Box 16532
Columbus OH 43216-6532

***************************************************************************************
Generic Name Approved Orphan Indication:
L-aminocarnityl-succinyl-leucyl-argininal-diethylacetal

Trade Name:
Orphan Designation:
Treatment of Duchenne and Becker muscular dystrophy

Designation
1/18/2006 Sponsor and Address
Marketing Exclusivity CepTor Corporation
200 International Circle
Hunt Valley MD 21030

***************************************************************************************
Generic Name Approved Orphan Indication:
Lamotrigine Adjunctive treatment of Lennox-Gastaut syndrome in pediatric and
adult patients.

Trade Name:
Lamictal Orphan Designation:
Treatment of Lennox-Gastaut syndrome.

Designation
8/23/1995 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Research and Development
8/24/1998 5 Moore Drive
P.O. Box 13398
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Lanreotide Long-term treatment of acromegalic patients who have had an
inadequate response to or cannot be treated with surgery and/or
radiotherapy
Trade Name:
Somatuline Depot Orphan Designation:
Treatment for acromegly

Designation
9/11/2000 Sponsor and Address
Marketing Exclusivity IPSEN, Inc.
8/30/2007 27 Maple Street
Milford MA 01757

***************************************************************************************
Generic Name Approved Orphan Indication:
laronidase Treatment for patients with Hurler and Hurler-Scheie forms of
Mucopolysaccharidosis I (MPS I) and for patients with the Scheie
form who have moderate to severe symptoms
Trade Name:
Aldurazyme Orphan Designation:
Treatment of patients with mucopolysaccharidosis-I.

Designation
9/24/1997 Sponsor and Address
Marketing Exclusivity BioMarin Pharmaceutical, Inc.
4/30/2003 371 Bel Marin Keys Boulevard, Suite 210
Novato CA 94949-5608

***************************************************************************************
Generic Name Approved Orphan Indication:
Latrodectus immune F(ab)2

Trade Name:
Aracmyn Orphan Designation:
Treatment of black widow spider envenomations

Designation
6/18/2001 Sponsor and Address
Marketing Exclusivity Rare Disease Therapeutics, Inc.
1101 Kermit Drive, Suite 608
Nashville TN 37217

***************************************************************************************
Generic Name Approved Orphan Indication:
L-Baclofen

Trade Name:
Neuralgon Orphan Designation:
Treatment of intractable spasticity in children with cerebral palsy.

Designation
1/30/1992 Sponsor and Address
Marketing Exclusivity Pharmascience Inc.
6111 Royalmount, Suite 100
Montreal, Quebec H4P 2T4

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
L-baclofen

Trade Name:
Neuralgon Orphan Designation:
Treatment of intractable spasticity associated with spinal cord injury
or multiple sclerosis.
Designation
12/17/1991 Sponsor and Address
Marketing Exclusivity Pharmascience Inc.
6111 Royalmount, Suite 100
Montreal, Quebec H4P 2T4

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
L-Baclofen

Trade Name:
Orphan Designation:
Treatment of trigeminal neuralgia.

Designation
1/6/1998 Sponsor and Address
Marketing Exclusivity Pharmascience Inc.
6111 Royalmount, #100
Montreal, Quebec H4P 2T4

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
L-baclofen

Trade Name:
Orphan Designation:
Treatment of trigeminal neuralgia.

Designation
7/13/1990 Sponsor and Address
Marketing Exclusivity Fromm, Gerhard M.D.
University Of Pittsburgh School of Medicine
Pittsburgh PA 15261

***************************************************************************************
Generic Name Approved Orphan Indication:
L-cycloserine

Trade Name:
Orphan Designation:
Treatment of Gaucher's disease.

Designation
8/1/1989 Sponsor and Address
Marketing Exclusivity Lev, Meir M.D.
The City College, City University Of NY Medical Sc
Convent Avenue at 138 Street
New York NY 10031
***************************************************************************************
Generic Name Approved Orphan Indication:
L-cysteine

Trade Name:
Orphan Designation:
For the prevention and lessening of photosensitivity in erythropoietic
protoporphyria.
Designation
5/16/1994 Sponsor and Address
Marketing Exclusivity Brigham and Women's Hospital
Channing Laboratory
Dept. of Medicine
Boston MA 02115
***************************************************************************************
Generic Name Approved Orphan Indication:
Leflunomide

Trade Name:
Orphan Designation:
Prevention of acute and chronic rejection in patients who have
received solid organ transplants.
Designation
10/18/1996 Sponsor and Address
Marketing Exclusivity Williams, MD, James W.
Rush-Presbyterian-St. Luke's Medical Ctr., Dept. o
1653 West Congress Parkway
Chicago IL 60612-3833
***************************************************************************************
Generic Name Approved Orphan Indication:
lenalidomide Treatment of patients with transfusion dependant anemia due to low
or intermediate-1 risk myelodysplastic syndromes associated with a
deletion 5 q cytogenetic abnormality with or without additional
Trade Name: cytogenetic abnormalities
Revlimid Orphan Designation:
Treatment of myelodysplastic syndromes

Designation
1/29/2004 Sponsor and Address
Marketing Exclusivity Celgene Corporation
12/27/2005 86 Morris Avenue
Summit NJ 07901

***************************************************************************************
Generic Name Approved Orphan Indication:
lenalidomide

Trade Name:
Revlimid Orphan Designation:
Treatment of chronic lymphocytic leukemia.

Designation
1/17/2007 Sponsor and Address
Marketing Exclusivity Celgene Corporation
86 Morris Avenue
Summit NJ 07901

***************************************************************************************
Generic Name Approved Orphan Indication:
lenalidomide For use in combination with dexamethasone for the treatment of
multiple myeloma patients who have received at least one prior
therapy.
Trade Name:
Revlimid Orphan Designation:
Treatment for multiple myeloma

Designation
9/20/2001 Sponsor and Address
Marketing Exclusivity Celgene Corporation
6/29/2006 86 Morris Avenue
Summit NJ 07901

***************************************************************************************
Generic Name Approved Orphan Indication:
Lentiviral vector encoded with a human beta-globin
gene plasmid

Trade Name:
Thalagen Orphan Designation:
Treatment of beta-thalassemia major and beta-thalassemia intermedia

Designation
1/11/2006 Sponsor and Address
Marketing Exclusivity Errant Gene Therapeutics, LLC
200 West Jackson Blvd.
Chicago IL 60606

***************************************************************************************
Generic Name Approved Orphan Indication:
Lepirudin For anticoagulation in patients with heparin-induced
thrombocytopenia and associated thromboembolic disease in order
to prevent further thromboembolic complications.
Trade Name:
Refluden Orphan Designation:
Treatment of heparin-associated thrombocytopenia type II.

Designation
2/13/1997 Sponsor and Address
Marketing Exclusivity Hoechst Marion Roussel
3/6/1998 Frankfurt am Main
P.O. Box 1140
Marburg
GERMANY
***************************************************************************************
Generic Name Approved Orphan Indication:
Lestaurtinib

Trade Name:
Orphan Designation:
Treatment of acute myeloid leukemia

Designation
3/24/2006 Sponsor and Address
Marketing Exclusivity Cephalon, Inc.
41 Moores Road
Frazer PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Leucovorin For use in combination with 5-fluorouracil to prolong survival in the
palliative treatment of patients with advanced colorectal cancer.

Trade Name:
Leucovorin calcium Orphan Designation:
For use in combination with 5-fluorouracil for the treatment of
metastatic colorectal cancer.
Designation
12/8/1986 Sponsor and Address
Marketing Exclusivity Immunex Corporation
12/12/1991 51 University Street
Seattle WA 98101

***************************************************************************************
Generic Name Approved Orphan Indication:
Leucovorin

Trade Name:
Leucovorin calcium Orphan Designation:
For rescue use after high dose methotrexate therapy in the treatment
of osteosarcoma.
Designation
8/17/1988 Sponsor and Address
Marketing Exclusivity Immunex Corporation
8/31/1988 51 University Street
Seattle WA 98101

***************************************************************************************
Generic Name Approved Orphan Indication:
Leucovorin calcium

Trade Name:
Wellcovorin Orphan Designation:
For use in combination with 5-fluorouracil for the treatment of
metastatic colorectal cancer.
Designation
6/23/1988 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Research and Development
5 Moore Drive
PO Box 13398
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
leukocyte interlukin

Trade Name:
Multikine Orphan Designation:
Neoadjuvant therapy in patients with Squamous Cell Carcinoma of
the Head and Neck
Designation
5/4/2007 Sponsor and Address
Marketing Exclusivity CEL-SCI Corporation
8229 Boone Blvd.
Suite 802
Vienna VA 22182
***************************************************************************************
Generic Name Approved Orphan Indication:
Leupeptin

Trade Name:
Orphan Designation:
For use as an adjunct to microsurgical peripheral nerve repair.

Designation
9/18/1990 Sponsor and Address
Marketing Exclusivity Neuromuscular Adjuncts, Inc.
S.U.N.Y. at Stony Brook
H.S.C. T18-020
Stony Brook NY 11794-8181
***************************************************************************************
Generic Name Approved Orphan Indication:
Leuprolide acetate Treatment of children with central precocious puberty.

Trade Name:
Lupron Injection Orphan Designation:
Treatment of central precocious puberty.

Designation
7/25/1988 Sponsor and Address
Marketing Exclusivity Tap Pharmaceuticals, Inc.
4/16/1993 2355 Waukegan Road
Deerfield IL 60015

***************************************************************************************
Generic Name Approved Orphan Indication:
Levocabastine HCl ophthalmic suspension 0.05%

Trade Name:
Orphan Designation:
Treatment of vernal keratoconjunctivitis.

Designation
2/29/1988 Sponsor and Address
Marketing Exclusivity Iolab Pharmaceuticals
500 Iolab Drive
Claremont CA 94608

***************************************************************************************
Generic Name Approved Orphan Indication:
Levocarnitine Prevention and treatment of carnitine deficiency in patients with end
stage renal disease who are undergoing dialysis.

Trade Name:
Carnitor Orphan Designation:
Treatment of manifestations of carnitine deficiency in patients with
end stage renal disease who require dialysis.
Designation
9/6/1988 Sponsor and Address
Marketing Exclusivity Sigma-Tau Pharmaceuticals, Inc.
12/15/1999 800 South Frederick Avenue, Suite 300
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Levocarnitine

Trade Name:
Carnitor Orphan Designation:
Treatment of manifestations of carnitine deficiency in patients with
end stage renal disease who require dialysis.
Designation
11/24/1986 Sponsor and Address
Marketing Exclusivity Sigma-Tau Pharmaceuticals, Inc.
800 South Frederick Avenue
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Levocarnitine

Trade Name:
Carnitor Orphan Designation:
For the treatment of secondary carnitine deficiency in valproic acid
toxicity.
Designation
11/15/1989 Sponsor and Address
Marketing Exclusivity Sigma-Tau Pharmaceuticals, Inc.
800 South Frederick Avenue
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Levocarnitine

Trade Name:
Carnitor Orphan Designation:
For the prevention of secondary carnitine deficiency in valproic acid
toxicity.
Designation
11/15/1989 Sponsor and Address
Marketing Exclusivity Sigma-Tau Pharmaceuticals, Inc.
800 South Frederick Avenue
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Levocarnitine

Trade Name:
Carnitor Orphan Designation:
Treatment of zidovudine-induced mitochondrial myopathy.

Designation
4/7/1997 Sponsor and Address
Marketing Exclusivity Sigma-Tau Pharmaceuticals, Inc.
800 S. Frederick Avenue, Suite 300
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Levocarnitine

Trade Name:
Carnitor Orphan Designation:
Treatment of pediatric cardiomyopathy.

Designation
11/22/1993 Sponsor and Address
Marketing Exclusivity Sigma-Tau Pharmaceuticals, Inc.
800 South Frederick Avenue
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Levocarnitine Treatment of primary systemic carnitine deficiency. (approved
12/27/85)
Treatment of secondary carnitine deficiency. (approved 12/16/92)
Trade Name:
Carnitor Orphan Designation:
Treatment of primary and secondary carnitine deficiency of genetic
origin.
Designation
7/26/1984 Sponsor and Address
Marketing Exclusivity Sigma-Tau Pharmaceuticals, Inc.
12/16/1992 800 South Frederick Avenue
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Levocarnitine

Trade Name:
Carnitor Orphan Designation:
Treatment of genetic carnitine deficiency.

Designation
2/28/1984 Sponsor and Address
Marketing Exclusivity Sigma-Tau Pharmaceuticals, Inc.
4/10/1986 800 South Frederick Avenue
Gaithersburg MD 20877

***************************************************************************************
Generic Name Approved Orphan Indication:
Levodopa and carbidopa

Trade Name:
Duodopa Orphan Designation:
Treatment of late stage Parkinson's disease.

Designation
1/18/2000 Sponsor and Address
Marketing Exclusivity Solvay Pharmaceuticals, Inc.
901 Sawyer Road
Marietta GA 30062

***************************************************************************************
Generic Name Approved Orphan Indication:
Levomethadyl acetate hydrochloride For the management of opiate dependence.

Trade Name:
Orlaam Orphan Designation:
Treatment of heroin addicts suitable for maintenance on opiate
agonists.
Designation
1/24/1985 Sponsor and Address
Marketing Exclusivity Biodevelopment Corporation
7/9/1993 8180 Greensboro Drive, Suite 1000
McLean VA 22102

***************************************************************************************
Generic Name Approved Orphan Indication:
L-glutamine

Trade Name:
Orphan Designation:
Treatment of sickle cell disease

Designation
8/1/2001 Sponsor and Address
Marketing Exclusivity Emmaus Medical, Inc.
3870 Del Amo Blvd
Unit 507
Torrance CA 90503-7701
***************************************************************************************
Generic Name Approved Orphan Indication:
L-glutamyl-L-tryptophan

Trade Name:
Orphan Designation:
Treatment of AIDS-related Kaposi's sarcoma.

Designation
10/20/1999 Sponsor and Address
Marketing Exclusivity Implicit Bioscience Pty Ltd
P. O. Box 2072.
Toowong Business Center

AUSTRALIA
***************************************************************************************
Generic Name Approved Orphan Indication:
liarozole

Trade Name:
Orphan Designation:
The treatment of congenital ichthyosis

Designation
6/18/2004 Sponsor and Address
Marketing Exclusivity Barrier Therapeutics, Inc
600 College Road East
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Lidocaine patch 5%

Trade Name:
Lidoderm Patch Orphan Designation:
For relief of allodynia (painful hypersensitivity), and chronic pain in
postherpetic neuralgia.
Designation
10/24/1995 Sponsor and Address
Marketing Exclusivity Teikoku Pharma USA, Inc.
3/19/1999 745-D Camden Ave.
Campbell CA 95008-4146

***************************************************************************************
Generic Name Approved Orphan Indication:
Lintuzumab

Trade Name:
Orphan Designation:
Treatment of myelodysplastic syndrome.

Designation
3/20/2007 Sponsor and Address
Marketing Exclusivity Seattle Genetics, Inc.
21823 30th Drive Southeast
Bothell WA 98021

***************************************************************************************
Generic Name Approved Orphan Indication:
lintuzumab

Trade Name:
Orphan Designation:
Treatment of acute myeloid leukemia.

Designation
1/30/2007 Sponsor and Address
Marketing Exclusivity Seattle Genetics, Inc.
21823 30th Drive Southeast
Bothell WA 98021

***************************************************************************************
Generic Name Approved Orphan Indication:
lintuzumab

Trade Name:
Zamyl Orphan Designation:
Treatment of acute myelogenous leukemia

Designation
9/9/2002 Sponsor and Address
Marketing Exclusivity Protein Design Labs, Inc.
34801 Campus Drive
Fremont CA 94555

***************************************************************************************
Generic Name Approved Orphan Indication:
Liothyronine sodium injection Treatment of myxedema coma/precoma.

Trade Name:
Triostat Orphan Designation:
Treatment of myxedema coma/precoma.

Designation
7/30/1990 Sponsor and Address
Marketing Exclusivity SmithKline Beecham Pharmaceuticals
12/31/1991 One Franklin Plaza
P.O. Box 7929
Philadelphia PA 19101
***************************************************************************************
Generic Name Approved Orphan Indication:
Lipid/DNA human cystic fibrosis gene

Trade Name:
Orphan Designation:
Treatment of cystic fibrosis.

Designation
4/8/1996 Sponsor and Address
Marketing Exclusivity Genzyme Corporation
Metrowest Place
15 Pleasant Street Connector
Framingham MA 01701-9322
***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal amphotericin B

Trade Name:
AmBisome Orphan Designation:
Treatment of histoplasmosis.

Designation
12/10/1996 Sponsor and Address
Marketing Exclusivity Fujisawa USA, Inc.
3 Parkway North Center
Deerfield IL 60015

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal amphotericin B Treatment of visceral leishmaniasis.

Trade Name:
AmBisome Orphan Designation:
Treatment of visceral leishmaniasis.

Designation
12/6/1996 Sponsor and Address
Marketing Exclusivity Fujisawa USA, Inc.
8/11/1997 3 Parkway North Center
Deerfield IL 60015

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal amphotericin B Treatment of disseminated cryptococcosis including meningitis.

Trade Name:
AmBisome Orphan Designation:
Treatment of cryptococcal meningitis.

Designation
12/10/1996 Sponsor and Address
Marketing Exclusivity Fujisawa USA, Inc.
8/11/1997 3 Parkway North Center
Deerfield IL 60015

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal annamycin

Trade Name:
Orphan Designation:
Treatment of acute myeloid leukemia

Designation
6/17/2005 Sponsor and Address
Marketing Exclusivity Callisto Pharmaceuticals, Inc.
420 Lexington Avenue
New York NY 10170

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal annamycin

Trade Name:
Orphan Designation:
Treatment of acute lymphoblastic leukemia

Designation
6/17/2005 Sponsor and Address
Marketing Exclusivity Callisto Pharmaceuticals, Inc.
420 Lexington Avenue
New York NY 10170

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal ciprofloxacin

Trade Name:
Orphan Designation:
For the management of bronchiectasis

Designation
12/27/2006 Sponsor and Address
Marketing Exclusivity Aradigm Corporation
3929 Point Eden Way
Hayward CA 94545

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal ciprofloxacin for inhalation

Trade Name:
Orphan Designation:
Management of cystic fibrosis

Designation
4/19/2006 Sponsor and Address
Marketing Exclusivity Aradigm Corporation
3929 Point Eden Way
Hayward CA 94545

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal cisplatin

Trade Name:
LipOva-Pt Orphan Designation:
Treatment of ovarian cancer

Designation
5/23/2006 Sponsor and Address
Marketing Exclusivity Transave, Inc.
11 Deer Park Drive
Monmouth Junction NJ 08852-1923

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal cyclosporin A

Trade Name:
Cyclospire Orphan Designation:
For aerosolized administration in the prevention and treatment of
lung allograft rejection
Designation and pulmonary rejection events associated with bone marrow
4/30/1998 transplantation.
Sponsor and Address
Marketing Exclusivity Vernon Knight, M.D.
Baylor College of Medicine, Dept. of Molecular Phy
One Baylor Plaza
Houston TX 77030
***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal doxorubicin hydrochloride

Trade Name:
Sarcodoxome Orphan Designation:
Treatment of soft tissue sarcomas

Designation
12/27/2006 Sponsor and Address
Marketing Exclusivity GP-Pharm SA
Pol. Ind. Els Vinyets els Fogars n 2,
Quinti de Mediona
Barcelona
SPAIN
***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal N-Acetylglucosminyl-N-Acetylmuramly-L-
Ala-D-isoGln-L-Ala -gylcerolidpalmitoyl

Trade Name:
ImmTher Orphan Designation:
Treatment of osteosarcoma.

Designation
6/10/1998 Sponsor and Address
Marketing Exclusivity Endorex Corp.
900 North Shore Drive
Lake Bluff IL 60044

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal N-Acetylglucosminyl-N-Acetylmuramly-L-
Ala-D-isoGln-L-Ala -gylcerolidpalmitoyl

Trade Name:
ImmTher Orphan Designation:
Treatment of Ewing's sarcoma.

Designation
6/10/1998 Sponsor and Address
Marketing Exclusivity Endorex Corp.
900 North Shore Drive
Lake Bluff IL 60044

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal nystatin

Trade Name:
Nyotran Orphan Designation:
Treatment of invasive fungal infections.

Designation
6/13/2000 Sponsor and Address
Marketing Exclusivity The University of Texas
M.D. Anderson Cancer Center
Unit 038
Houston TX 77030
***************************************************************************************
Generic Name Approved Orphan Indication:
liposomal p-ethoxy growth receptor bound protein-2
antisense product

Trade Name:
Orphan Designation:
Treatment of chronic myelogenous leukemia

Designation
12/5/2003 Sponsor and Address
Marketing Exclusivity Interpath Pharmaceuticals, INc.
20651 Prince Creek Dr.
Katy TX 77450

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal prostaglandin E1 injection

Trade Name:
Orphan Designation:
Treatment of acute respiratory distress syndrome.

Designation
4/25/1996 Sponsor and Address
Marketing Exclusivity Liposome Company, Inc.
One Research Way
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposomal-cis-bis-neodecanoato-trans-R,R-1,2-
diaminocyclohexane-Pt (II)

Trade Name:
Aroplatin Orphan Designation:
Treatment of malignant mesothelioma.

Designation
9/1/1999 Sponsor and Address
Marketing Exclusivity Antigenics Incorporated
3 Forbes Road
Lexington MA 02421

***************************************************************************************
Generic Name Approved Orphan Indication:
Liposome encapsulated recombinant interleukin-2

Trade Name:
Orphan Designation:
Treatment of brain and CNS tumors.

Designation
11/25/1991 Sponsor and Address
Marketing Exclusivity Biomira, Inc.
2011 - 94th Street
Edmonston, AB

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Liposome encapsulated recombinant interleukin-2

Trade Name:
Orphan Designation:
Treatment of cancers of the kidney and renal pelvis.

Designation
6/20/1994 Sponsor and Address
Marketing Exclusivity Biomira, Inc.
2011 - 94th Street
T6N 1H1

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
Lisofylline

Trade Name:
Orphan Designation:
Treatment of patients undergoing induction therapy for acute
myeloid leukemia.
Designation
6/10/1999 Sponsor and Address
Marketing Exclusivity Cell Therapeutics, Inc.
201 Elliot Avenue West201
Suite 400
Seattle WA 98119
***************************************************************************************
Generic Name Approved Orphan Indication:
L-leucovorin

Trade Name:
Isovorin Orphan Designation:
For use in combination chemotherapy with the approved agent 5-
fluorouracil in the palliative treatment of metastatic adenocarcinoma
Designation of the colon and rectum.
12/18/1990 Sponsor and Address
Marketing Exclusivity Targent, Inc.
181 Cherry Valley Road
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
L-leucovorin

Trade Name:
Isovorin Orphan Designation:
For use in conjunction with high-dose methotrexate in the treatment
of osteosarcoma.
Designation
8/1/1991 Sponsor and Address
Marketing Exclusivity Targent, Inc.
181 Cherry Valley Road
Princeton NJ 08540

***************************************************************************************
Generic Name Approved Orphan Indication:
Lodoxamide tromethamine Treatment of ocular disorders referred to by the terms vernal
keratoconjunctivitis, vernal conjunctivitis, vernal keratitis.

Trade Name:
Alomide Ophthalmic Solution Orphan Designation:
Treatment of vernal keratoconjunctivitis.

Designation
10/16/1991 Sponsor and Address
Marketing Exclusivity Alcon Laboratories, Inc.
9/23/1993 6201 South Freeway
Fort Worth TX 76134

***************************************************************************************
Generic Name Approved Orphan Indication:
Loxoribine

Trade Name:
Orphan Designation:
Treatment of common variable immunodeficiency.

Designation
2/24/1992 Sponsor and Address
Marketing Exclusivity R. W. Johnson Pharmaceutical Research Institute
Route 202, P.O. Box 300
Raritan NJ 08869

***************************************************************************************
Generic Name Approved Orphan Indication:
L-threonine

Trade Name:
Orphan Designation:
Treatment of spasticity associated with familial spastic paraparesis.

Designation
7/24/1992 Sponsor and Address
Marketing Exclusivity Interneuron Pharmaceuticals, Inc.
99 Hayden Ave., Suite 200
Lexington MA 02421-7966

***************************************************************************************
Generic Name Approved Orphan Indication:
L-threonine

Trade Name:
Threostat Orphan Designation:
Treatment of amyotrophic lateral sclerosis.

Designation
2/6/1989 Sponsor and Address
Marketing Exclusivity Tyson And Associates
12832 Chadron Avenue
Hawthorne CA 90250

***************************************************************************************
Generic Name Approved Orphan Indication:
L-threonyl-L-prolyl-L-prolyl-L-threonine

Trade Name:
Orphan Designation:
Treatment of neuropathic pain associated with spinal cord injury

Designation
4/26/2005 Sponsor and Address
Marketing Exclusivity Nyxis Neurotherapies, Inc.
1801 Maple Avenue
Suite 4300
Evanston IL 60201
***************************************************************************************
Generic Name Approved Orphan Indication:
L-tyrosine-L-serine-L-leucine

Trade Name:
CMS-024 Orphan Designation:
Treatment of hepatocellular carcinoma.

Designation
9/10/2004 Sponsor and Address
Marketing Exclusivity CMS Peptides Patent Holding Company Limited
Subsidiary of China Medical System Holdings Limite
Room 1404, 14th Floor
North Point
HONG KONG
***************************************************************************************
Generic Name Approved Orphan Indication:
Lucinactant

Trade Name:
Surfaxin Orphan Designation:
Prevention of bronchopulmonary dysplasia in premature infants

Designation
5/23/2006 Sponsor and Address
Marketing Exclusivity Discovery Laboratories, Inc
2600 Kelly Road
Warrington PA 18976

***************************************************************************************
Generic Name Approved Orphan Indication:
Lucinactant

Trade Name:
Surfaxin Orphan Designation:
Treatment of bronchopulmonary dysplasia in premature infants.

Designation
10/21/2005 Sponsor and Address
Marketing Exclusivity Discovery Labsoratories, Inc.
2600 Kelly Road
Warrington PA 18976

***************************************************************************************
Generic Name Approved Orphan Indication:
Lucinactant

Trade Name:
Surfaxin Orphan Designation:
Treatment of meconium aspiration syndrome in newborn infants

Designation
7/30/1996 Sponsor and Address
Marketing Exclusivity Discovery Laboratories, Inc.
2600 Kelly Road
Warrington PA 18976

***************************************************************************************
Generic Name Approved Orphan Indication:
Lucinactant

Trade Name:
Surfaxin Orphan Designation:
Treatment of acute respiratory distress syndrome in adults.

Designation
7/17/1995 Sponsor and Address
Marketing Exclusivity Discovery Laboratories, Inc.
2600 Kelly Road
Warrington PA 18976

***************************************************************************************
Generic Name Approved Orphan Indication:
Lucinactant

Trade Name:
Surfaxin Orphan Designation:
Treatment of respiratory distress syndrome in premature infants.

Designation
10/18/1995 Sponsor and Address
Marketing Exclusivity Discovery Laboratories, Inc.
2600 Kelly Road
Warrington PA 18976

***************************************************************************************
Generic Name Approved Orphan Indication:
Lysine acetylsalicylate injectable

Trade Name:
Orphan Designation:
Treatment of pain and fever secondary to sickle cell disease crisis.

Designation
8/1/1989 Sponsor and Address
Marketing Exclusivity G.D. Searle & Company
4901 Searle Parkway
Skokie IL 60077

***************************************************************************************
Generic Name Approved Orphan Indication:
Mafenide acetate solution

Trade Name:
Sulfamylon solution Orphan Designation:
For use as an adjunctive topical antimicrobial agent to control
bacterial infection when used under moist dressings over meshed
Designation autografts on excised burn wounds.
7/18/1990 Sponsor and Address
Marketing Exclusivity Mylan Laboratories, Inc.
6/5/1998 781 Chestnut Ridge Road
P.O. Box 4310
Morgantown WV 26504-4310
***************************************************************************************
Generic Name Approved Orphan Indication:
Mafosfamide

Trade Name:
Orphan Designation:
Treatment of neoplastic meningitis

Designation
1/21/2003 Sponsor and Address
Marketing Exclusivity Baxter Healthcare Corporation
Route 120 & Wilson Road
Round Lake IL 60073-0490

***************************************************************************************
Generic Name Approved Orphan Indication:
Mammalian target of rapamcyin (mTOR) inhibitor

Trade Name:
Orphan Designation:
Treatment of soft tissue sarcoma

Designation
8/12/2005 Sponsor and Address
Marketing Exclusivity ARIAD Pharmaceuticals, Inc
26 Landsdowne Street
Cambridge MA 02139-4234

***************************************************************************************
Generic Name Approved Orphan Indication:
Mannitol

Trade Name:
Bronchitol Orphan Designation:
For use to facilitate clearance of mucus in patients with
bronchiectasis and in patients with cystic fibrosis at risk for
Designation bronchiectasis
2/11/2005 Sponsor and Address
Marketing Exclusivity Pharmaxis Ltd.
10 Rodborough Rd.
NSW 2086

AUSTRALIA
***************************************************************************************
Generic Name Approved Orphan Indication:
mannopentaose phosphate sulfate

Trade Name:
Orphan Designation:
Treatment of high-risk Stage II, Stage III, and Stage IV melanoma

Designation
4/27/2004 Sponsor and Address
Marketing Exclusivity Progen Industries Limited
P. O. Box 28
Richlands 4077

AUSTRALIA
***************************************************************************************
Generic Name Approved Orphan Indication:
maribavir

Trade Name:
Orphan Designation:
Prevention of cytomegalovirus viremia and disease in the
populations at risk.
Designation
2/1/2007 Sponsor and Address
Marketing Exclusivity ViroPharma Inc.
397 Eagleview Blvd.
Exton PA 19341

***************************************************************************************
Generic Name Approved Orphan Indication:
Marijuana

Trade Name:
Orphan Designation:
Treatment of HIV-associated wasting syndrome.

Designation
5/25/1999 Sponsor and Address
Marketing Exclusivity Multidisciplinary Association for Psychedelic Studies, Inc.
3 Francis St.
Belmont MA 02478

***************************************************************************************
Generic Name Approved Orphan Indication:
Matrix metalloproteinase inhibitor

Trade Name:
Galardin Orphan Designation:
Treatment of corneal ulcers.

Designation
12/5/1991 Sponsor and Address
Marketing Exclusivity Glycomed, Inc
860 Atlantic Avenue
Alameda CA 94501

***************************************************************************************
Generic Name Approved Orphan Indication:
MaxAdFVIII

Trade Name:
Orphan Designation:
Treatment of Hemophilia A

Designation
3/3/2003 Sponsor and Address
Marketing Exclusivity GenStar Therapeutics Corporation
10865 Altman Row
Suite 200
San Diego CA 92121-1113
***************************************************************************************
Generic Name Approved Orphan Indication:
Mazindol

Trade Name:
Sanorex Orphan Designation:
Treatment of Duchenne muscular dystrophy.

Designation
12/8/1986 Sponsor and Address
Marketing Exclusivity Collipp, Platon J. M.D.
176 Memorial Drive
Jesup GA 31545

***************************************************************************************
Generic Name Approved Orphan Indication:
Mecamylamine

Trade Name:
Inversine Orphan Designation:
Treatment of Tourette's syndrome.

Designation
10/14/1998 Sponsor and Address
Marketing Exclusivity Targacept, Inc.
200 East First St.
Suite 300
Winston-Salem NC 27101-4165
***************************************************************************************
Generic Name Approved Orphan Indication:
Mecasermin

Trade Name:
Myotrophin Orphan Designation:
Treatment of amyotrophic lateral sclerosis.

Designation
8/5/1991 Sponsor and Address
Marketing Exclusivity Cephalon, Inc.
41 Moores Road
P. O. Box 4011
Frazer PA 19355
***************************************************************************************
Generic Name Approved Orphan Indication:
Mecasermin Long-term treatment of growth failure in children with severe primary
IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene
deletion who have developed neutralizing antibodies to growth
Trade Name: hormone.
Increlex Orphan Designation:
Treatment of growth hormone insensitivity syndrome.

Designation
12/12/1995 Sponsor and Address
Marketing Exclusivity Tercica, Inc.
8/30/2005 2000 Sierra Point Parkway
Suite 400
Brisbane CA 94005
***************************************************************************************
Generic Name Approved Orphan Indication:
mecasermin rinfabate Treatment of growth failure in children with severe primary IGF-1
deficiency (Primary IGFD) or with growth hormone (GH) gene deletion
who have developed neutralizing antibodies to growth hormone
Trade Name:
iPLEX Orphan Designation:
Treatment of growth hormone insensitivity syndrome (GHIS)

Designation
5/17/2002 Sponsor and Address
Marketing Exclusivity Insmed, Inc.
12/12/2005 8720 Stony Point Parkway
Suite 200
Richmond VA 23235
***************************************************************************************
Generic Name Approved Orphan Indication:
meclorethamine or nitrogen mustard

Trade Name:
Orphan Designation:
Treatment of mycosis fungoides.

Designation
8/12/2004 Sponsor and Address
Marketing Exclusivity Yaupon Therapeutics, Inc.
259 Radnor Chester Road
Radnor PA 19087

***************************************************************************************
Generic Name Approved Orphan Indication:
MEDI-522

Trade Name:
Vitaxin Orphan Designation:
For the treatment of metastatic melanoma

Designation
4/14/2004 Sponsor and Address
Marketing Exclusivity MedImmune Oncology. Inc
One MedImmune Way
Gaithersburg MD 20878

***************************************************************************************
Generic Name Approved Orphan Indication:
Medroxyprogesterone acetate

Trade Name:
Hematrol Orphan Designation:
Treatment of immune thrombocytopenic purpura.

Designation
2/22/2001 Sponsor and Address
Marketing Exclusivity InKine Pharmaceutical Company, Inc.
1787 Sentry Parkway West
Building 18, Suite 440
Blue Bell PA 19422
***************************************************************************************
Generic Name Approved Orphan Indication:
Mefloquine HCl

Trade Name:
Mephaquin Orphan Designation:
Prevention of chloroquine-resistant Falciparum malaria.

Designation
7/22/1987 Sponsor and Address
Marketing Exclusivity Mepha AG
4143 Dornach
POSTFASH 137

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
Mefloquine HCl

Trade Name:
Mephaquin Orphan Designation:
Treatment of chloroquine-resistant Falciparummalaria.

Designation
7/22/1987 Sponsor and Address
Marketing Exclusivity Mepha AG
4143 Dornach
POSTFASH 137

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
Mefloquine HCl

Trade Name:
Lariam Orphan Designation:
Prophylaxis of Plasmodium falciparum malaria which is resistant to
other available drugs.
Designation
4/13/1988 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
5/2/1989 340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Mefloquine HCl

Trade Name:
Lariam Orphan Designation:
Treatment of acute malaria due to Plasmodium falciparum and
Plasmodium vivax.
Designation
4/13/1988 Sponsor and Address
Marketing Exclusivity Hoffmann-La Roche, Inc.
5/2/1989 340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Megestrol acetate Treatment of anorexia, cachexia, or an unexplained significant
weight loss in patients with a diagnosis of acquired immune
deficiency syndrome.
Trade Name:
Megace Orphan Designation:
Treatment of patients with anorexia, cachexia, or significant weight
loss (=/>10% of baseline body weight) and confirmed diagnosis of
Designation AIDS.
4/13/1988 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Pharmaceutical Research Institute
9/10/1993 2400 West Lloyd Expressway
Evansville IN 47721

***************************************************************************************
Generic Name Approved Orphan Indication:
Melanoma autologous dendritic cell vaccine

Trade Name:
Orphan Designation:
Treatment of stage IIIb through IV metastatic melanoma

Designation
9/6/2006 Sponsor and Address
Marketing Exclusivity Hoag Memorial Hospital Presbyterian
Hoag Cancer Center Cell Biology Laboratory
Building 41
Newport Beach CA 92658
***************************************************************************************
Generic Name Approved Orphan Indication:
Melanoma cell vaccine

Trade Name:
Canvaxin Orphan Designation:
Treatment of invasive melanoma.

Designation
10/13/1994 Sponsor and Address
Marketing Exclusivity CancerVax Corporation
2110 Rutherford Road
Carlsbad CA 92008

***************************************************************************************
Generic Name Approved Orphan Indication:
Melanoma peptide vaccine

Trade Name:
Orphan Designation:
Treatment of HLA-A2+ patients with stage IIB, IIC, III, and IV
malignant melanoma
Designation
3/29/2005 Sponsor and Address
Marketing Exclusivity Bristol-Myers Squibb Research Inst
5 Research Parkway
P. O. Box 5100
Wallingford CT 06492
***************************************************************************************
Generic Name Approved Orphan Indication:
Melanoma vaccine

Trade Name:
Melacine Orphan Designation:
Treatment of stage III - IV melanoma.

Designation
12/20/1989 Sponsor and Address
Marketing Exclusivity Ribi ImmunoChem Research, Inc.
533 Old Corvallis Road
Hamilton MT 59840

***************************************************************************************
Generic Name Approved Orphan Indication:
Melatonin

Trade Name:
Circadin Orphan Designation:
Treatment of non-24-hour sleep-wake disorder in blind individuals
without light perception
Designation
7/9/2004 Sponsor and Address
Marketing Exclusivity Neurim Pharmaceuticals, Ltd.
8 Hanechoshet St.
Tel-Aviv

ISRAEL
***************************************************************************************
Generic Name Approved Orphan Indication:
Melatonin

Trade Name:
Orphan Designation:
Treatment of circadian rhythm sleep disorders in blind people with no
light perception.
Designation
11/15/1993 Sponsor and Address
Marketing Exclusivity Sack, Robert, M.D.
Oregon Health Sciences University
3181 S.W. Sam Jackson Park Road
Portland OR 97201
***************************************************************************************
Generic Name Approved Orphan Indication:
meloxicam For relief of the signs and symptoms of pauciarticular or polyarticular
course Juvenile Rheumatoid Arthritis in patients 2 years of age or
older
Trade Name:
Mobic Orphan Designation:
Treatment of juvenile rheumatoid arthritis

Designation
11/22/2002 Sponsor and Address
Marketing Exclusivity Boehringer Ingelheim Pharmaceuticals, Inc.
8/11/2005 900 Ridgebury Road
P. O. Box 368
Ridgefield CT 06877-0368
***************************************************************************************
Generic Name Approved Orphan Indication:
Melphalan

Trade Name:
Alkeran for Injection Orphan Designation:
For use in hyperthermic regional limb perfusion to treat metastatic
melanoma of the extremity.
Designation
3/3/1992 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Research and Development
5 Moore Drive
PO Box 13398
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Melphalan For the palliative treatment of patients with multiple myeloma for
whom oral melphalan is not appropriate.

Trade Name:
Alkeran For Injection Orphan Designation:
Treatment of patients with multiple myeloma for whom oral therapy
is inappropriate.
Designation
2/24/1992 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Inc.
11/18/1992 5 Moore Drive
Research Triangle Park NC 27709

***************************************************************************************
Generic Name Approved Orphan Indication:
mepivacaine

Trade Name:
Orphan Designation:
Treatment of postherpetic neuralgia

Designation
1/8/2007 Sponsor and Address
Marketing Exclusivity Cinergen, LLC
146 Medinah Drive
Blue Bell PA 19422-3212

***************************************************************************************
Generic Name Approved Orphan Indication:
Mepivacaine

Trade Name:
Orphan Designation:
Treatment of painful HIV-associated neuropathy

Designation
10/18/2006 Sponsor and Address
Marketing Exclusivity Cinergen
146 Medinah Drive
Blue Bell PA 19422-3212

***************************************************************************************
Generic Name Approved Orphan Indication:
mepolizumab

Trade Name:
Orphan Designation:
For first-line treatment in patients with hypereosinophilic syndrome

Designation
5/28/2004 Sponsor and Address
Marketing Exclusivity GlaxoSmithKline Pharmaceuticals
P.O. Box 7929
Philadelphia PA 19101

***************************************************************************************
Generic Name Approved Orphan Indication:
Meropenem

Trade Name:
Merrem IV Orphan Designation:
Management of acute pulmonary exacerbations, in cystic fibrosis
patients, due to respiratory tract infection with susceptible organisms.
Designation
4/27/2000 Sponsor and Address
Marketing Exclusivity AstraZeneca Pharmaceuticals
1800 Concord Pike
PO Box 15437
Wilmington DE 19850-5437
***************************************************************************************
Generic Name Approved Orphan Indication:
Mesna

Trade Name:
Orphan Designation:
Inhibition of the urotoxic effects induced by oxazaphosphorine
compounds such as cyclophosphamide.
Designation
12/16/1987 Sponsor and Address
Marketing Exclusivity Asta Medica , Inc.
890 East St.
Tewksbury MA 01876-1496

***************************************************************************************
Generic Name Approved Orphan Indication:
Mesna

Trade Name:
Mesnex Orphan Designation:
For use as a prophylactic agent in reducing the incidence of
ifosfamide-induced hemorrhagic cystitis.
Designation
11/14/1985 Sponsor and Address
Marketing Exclusivity Degussa Corporation
12/30/1988 65 Challenger Road
Ridgefield Park NJ 07660

***************************************************************************************
Generic Name Approved Orphan Indication:
Methionine/L-methionine

Trade Name:
Orphan Designation:
Treatment of AIDS myelopathy.

Designation
8/21/1996 Sponsor and Address
Marketing Exclusivity Genopia USA, Inc.
90 Gold Street, 6N
New York NY 10038

***************************************************************************************
Generic Name Approved Orphan Indication:
Methotrexate

Trade Name:
Rheumatrex Orphan Designation:
Treatment of juvenile rheumatoid arthritis.

Designation
8/23/1993 Sponsor and Address
Marketing Exclusivity Wyeth-Ayerst Laboratories
P.O. Box 8299
Philadelphia PA 19101-8299

***************************************************************************************
Generic Name Approved Orphan Indication:
Methotrexate sodium For the use of high dose methotrexate with leucovorin rescue in
patients with non-metastatic osteosarcoma who have undergone
surgical resection or amputation for the primary tumor.
Trade Name:
Methotrexate Orphan Designation:
Treatment of osteogenic sarcoma.

Designation
10/21/1985 Sponsor and Address
Marketing Exclusivity Lederle Laboratories
4/7/1988 Division of American Cyanamid Company
401 N. Middletown Road
Pearl River NY 10965
***************************************************************************************
Generic Name Approved Orphan Indication:
Methotrexate with laurocapram

Trade Name:
Methotrexate/azone Orphan Designation:
Topical treatment of mycosis fungoides.

Designation
10/15/1990 Sponsor and Address
Marketing Exclusivity Durham Pharmaceuticals LLC
200 Westpark Corporate Center
4364 South Alston Avenue
Durham NC 27713-2280
***************************************************************************************
Generic Name Approved Orphan Indication:
Methoxsalen

Trade Name:
Uvadex Orphan Designation:
For use in conjunction with the UVAR photopheresis system to treat
graft versus host disease.
Designation
10/14/1998 Sponsor and Address
Marketing Exclusivity Therakos, Inc.
437 Creamery Way
Exton PA 19431

***************************************************************************************
Generic Name Approved Orphan Indication:
metreleptin

Trade Name:
Orphan Designation:
Treatment of metabolic disorders secondary to lipodystrophy

Designation
8/22/2001 Sponsor and Address
Marketing Exclusivity Amylin Pharmaceuticals, Inc.
9360 Towne Centre Drive
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
metreleptin

Trade Name:
Orphan Designation:
Treatment of leptin deficiency secondary to generalized
lipodystrophy and partial familial lipodystrophy
Designation
8/22/2001 Sponsor and Address
Marketing Exclusivity Amylin Pharmaceuticals, Inc.
9360 Towne Center Drive
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
Metronidazole

Trade Name:
Metrogel Orphan Designation:
Treatment of perioral dermatitis.

Designation
10/24/1991 Sponsor and Address
Marketing Exclusivity Galderma Laboratories, Inc.
P.O. Box 331329
Fort Worth TX 76163

***************************************************************************************
Generic Name Approved Orphan Indication:
Metronidazole (topical)

Trade Name:
Flagyl Orphan Designation:
Treatment of grade III and IV, anaerobically infected, decubitus
ulcers.
Designation
11/24/1987 Sponsor and Address
Marketing Exclusivity Searle
4901 Searle Parkway
Skokie IL 60077

***************************************************************************************
Generic Name Approved Orphan Indication:
Metronidazole (topical)

Trade Name:
Metrogel Orphan Designation:
Treatment of acne rosacea.

Designation
10/22/1987 Sponsor and Address
Marketing Exclusivity Galderma Laboratories, Inc.
11/22/1988 P.O. Box 331329
Fort Worth TX 76163

***************************************************************************************
Generic Name Approved Orphan Indication:
Mibefradil

Trade Name:
Orphan Designation:
Treatment of ovarian cancer

Designation
6/15/2007 Sponsor and Address
Marketing Exclusivity Tau Therapeutics, LLC
2988 Cove Trace
Charlottesville VA 22911

***************************************************************************************
Generic Name Approved Orphan Indication:
Microbubble contrast agent

Trade Name:
Filmix Neurosonographic Contrast Agent Orphan Designation:
Intraoperative aid in the identification and localization of intracranial
tumors.
Designation
11/16/1990 Sponsor and Address
Marketing Exclusivity Cav-Con, Inc.
55 Knollwood Road
Farmington CT 06032

***************************************************************************************
Generic Name Approved Orphan Indication:
Microvesiculated modified glycosylated tissue factor

Trade Name:
Orphan Designation:
Treatment of non-life threatening, mild to severe bleeding episodes
due to cutaneous injuries or dental procedures in hemophiliac
Designation patients
1/25/2007 Sponsor and Address
Marketing Exclusivity Thrombotargets Corp.
2530 Meridian Parkway
Suite 3023
Durham NC 27713
***************************************************************************************
Generic Name Approved Orphan Indication:
Midazolam HCl

Trade Name:
Orphan Designation:
Treatment of bouts of increased seizure activity in selected refractory
patients with epilepsy who are on stable regimens of anti-epileptic
Designation drugs and who require intermittent use of midazolam
5/8/2006 Sponsor and Address
Marketing Exclusivity Schwarz Biosciences, Inc.
8010 Arco Corporate Drive
Raleigh NC 27617

***************************************************************************************
Generic Name Approved Orphan Indication:
Midodrine HCl Treatment of symptomatic orthostatic hypotension.

Trade Name:
Amatine Orphan Designation:
Treatment of patients with symptomatic orthostatic hypotension.

Designation
12/5/1996 Sponsor and Address
Marketing Exclusivity Schier Ridgewood F.K.A. (Roberts Pharmaceutical Corp.)
9/6/1996 Meridian Center III
6 Industrial Way West
Eatontown NJ 07724
***************************************************************************************
Generic Name Approved Orphan Indication:
mifamuritide

Trade Name:
Junovan Orphan Designation:
Treatment of osteosarcoma

Designation
6/5/2001 Sponsor and Address
Marketing Exclusivity Immuno-Designed Molecules
9 Parker
Irvine CA 92618-1605

***************************************************************************************
Generic Name Approved Orphan Indication:
Mifepristone

Trade Name:
Orphan Designation:
Treatment of Cushing's syndrome secondary to ectopic ACTH secretion

Designation
2/7/2005 Sponsor and Address
Marketing Exclusivity HRA Pharma
19, rue Frederick Lmaitre
75020 Paris

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
mifepristone

Trade Name:
Corlux Orphan Designation:
Treatment of the clinical manifestations of endogenous Cushing's
symdrome.
Designation
7/5/2007 Sponsor and Address
Marketing Exclusivity Corcept Therapeutics, Inc.
149 Commonwealth Drive
Menlo Park CA 94025

***************************************************************************************
Generic Name Approved Orphan Indication:
miglustat Treatment of mild to moderate Type I Gaucher disease in adults for
whom enzyme replacement therapy is not a therapeutic option (e.g.,
due to constraints such as allergy, hypersensitivity, or poor venous
Trade Name: access).
Zavesca Orphan Designation:
Treatment of Gaucher disease.

Designation
5/29/1998 Sponsor and Address
Marketing Exclusivity Actelion Pharmaceuticals Ltd
7/31/2003 Gewerbestrasse 16
CH - 4123 Allschwi

SWITZERLAND
***************************************************************************************
Generic Name Approved Orphan Indication:
miltefosine

Trade Name:
Impavido Orphan Designation:
Treatment of leishmaniasis.

Designation
10/10/2006 Sponsor and Address
Marketing Exclusivity Zentaris GmbH
Weismullerstrasse 50

GERMANY
***************************************************************************************
Generic Name Approved Orphan Indication:
Minocycline HCl

Trade Name:
Minocin Intravenous Orphan Designation:
Treatment of chronic malignant pleural effusion.

Designation
6/19/1992 Sponsor and Address
Marketing Exclusivity Lederle Laboratories Division
Division of American Cyanamid Company
401 N. Middletown Road
Pearl River NY 10965
***************************************************************************************
Generic Name Approved Orphan Indication:
Minocycline hydrochloride

Trade Name:
Orphan Designation:
Treatment of sarcoidosis

Designation
3/28/2006 Sponsor and Address
Marketing Exclusivity Autoimmunity Research Foundation
Autoimmunity Research, Inc.
Thousand Oaks CA 91360

***************************************************************************************
Generic Name Approved Orphan Indication:
misoprostol

Trade Name:
GyMiso Orphan Designation:
Treatment of intrauterine fetal death not accompanied by complete
expulsion of the products of conception in the second and third
Designation trimesters of pregnancy.
1/10/2005 Sponsor and Address
Marketing Exclusivity Gynuity Health Projects, LLC
15 East 26th Street
New York NY 10010

***************************************************************************************
Generic Name Approved Orphan Indication:
Mitoguazone

Trade Name:
apep Orphan Designation:
Treatment of diffuse non-Hodgkin's lymphoma, including AIDS-
related diffuse non-Hodgkin's lymphoma.
Designation
3/18/1994 Sponsor and Address
Marketing Exclusivity ILEX Oncology, Inc.
4545 Horizon Hill Blvd.
San Antonio TX 78229-2263

***************************************************************************************
Generic Name Approved Orphan Indication:
Mitolactol

Trade Name:
Orphan Designation:
Treatment of invasive carcinoma of the uterine cervix

Designation
1/23/1989 Sponsor and Address
Marketing Exclusivity Biopharmaceutics, Inc.
990 Station Road
Bellport NY 11713

***************************************************************************************
Generic Name Approved Orphan Indication:
Mitolactol

Trade Name:
Orphan Designation:
As adjuvant therapy in the treatment of primary brain tumors.

Designation
7/12/1995 Sponsor and Address
Marketing Exclusivity Biopharmaceutics, Inc.
990 Station Road
Bellport NY 11713

***************************************************************************************
Generic Name Approved Orphan Indication:
Mitomycin-C

Trade Name:
Orphan Designation:
Treatment of refractory glaucoma as an adjunct to ab externo
glaucoma surgery.
Designation
8/20/1993 Sponsor and Address
Marketing Exclusivity IOP Inc.
3100 Airway Avenue, Suite 106
Costa Mesa CA 92626

***************************************************************************************
Generic Name Approved Orphan Indication:
Mitoxantrone In combination with corticosteroids as initial chemotherapy for the
treatment of patients with pain related to advanced hormone-
refractory prostate cancer.
Trade Name:
Novantrone Orphan Designation:
Treatment of hormone refractory prostate cancer.

Designation
8/21/1996 Sponsor and Address
Marketing Exclusivity Serono
11/13/1996 One Technology Place
Rockland MA 02370

***************************************************************************************
Generic Name Approved Orphan Indication:
Mitoxantrone Reducing neurologic disability and/or the frequency of clinical
relapses in patients with secondary (chronic) progressive, progressive
relapsing, or worsening relapsing-remitting multiple sclerosis (i.e.,
Trade Name: patients whose neurologic status is significantly adnormal between
Novantrone Orphan Designation:
Treatment of secondary-progressive multiple sclerosis.

Designation
8/13/1999 Sponsor and Address
Marketing Exclusivity Serono, Inc.
10/13/2000 One Technoloogy Place
Rockland MA 02370

***************************************************************************************
Generic Name Approved Orphan Indication:
Mitoxantrone Reducing neurologic disability and/or the frequency of clinical
relapses in patients with secondary (chronic) progressive, progressive
relapsing, or worsening relapsing-remitting multiple sclerosis (i.e.,
Trade Name: patients whose neurologic status is significantly adnormal between
Novantrone Orphan Designation:
Treatment of progressive-relapsing multiple sclerosis.

Designation
8/13/1999 Sponsor and Address
Marketing Exclusivity Serono, Inc.
10/13/2000 One Technology Place
Rockland MA 02370

***************************************************************************************
Generic Name Approved Orphan Indication:
Mitoxantrone HCl

Trade Name:
Novantrone Orphan Designation:
Treatment of acute myelogenous leukemia, also referred to as acute
nonlymphocytic leukemia.
Designation
7/13/1987 Sponsor and Address
Marketing Exclusivity Lederle Laboratories
12/23/1987 Division of American Cyanamid Company
401 N. Middletown Road
Pearl River NY 10965
***************************************************************************************
Generic Name Approved Orphan Indication:
MN14 monoclonal antibody to carcinoembryonic
antigen
Trade Name:
Cea-Cide Orphan Designation:
Treatment of small cell lung cancer

Designation
9/18/1998 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Rd.
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
MN14 monoclonal antibody to carcinoembryonic
antigen
Trade Name:
Cea-Cide Orphan Designation:
Treatment of pancreatic cancer.

Designation
11/24/1998 Sponsor and Address
Marketing Exclusivity Immunomedics, Inc.
300 American Road
Morris Plains NJ 07950

***************************************************************************************
Generic Name Approved Orphan Indication:
Modafinil Improve wakefulness in patients with excessive daytime sleepiness
associated with narcolepsy.

Trade Name:
Provigil Orphan Designation:
Treatment of excessive daytime sleepiness in narcolepsy.

Designation
3/15/1993 Sponsor and Address
Marketing Exclusivity Cephalon, Inc.
12/24/1998 145 Brandywine Parkway
West Chester PA 19380

***************************************************************************************
Generic Name Approved Orphan Indication:
Molgramostim

Trade Name:
Leucomax Orphan Designation:
Treatment of AIDS patients with neutropenia due to the disease,
AZTor ganciclovir.
Designation
1/24/1989 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
Molgramostim

Trade Name:
Leucomax Orphan Designation:
Treatment of aplastic anemia.

Designation
9/25/1989 Sponsor and Address
Marketing Exclusivity Schering Corporation
2000 Galloping Hill Road
Kenilworth NJ 07033

***************************************************************************************
Generic Name Approved Orphan Indication:
monarsen

Trade Name:
Orphan Designation:
Treatment of Myasthenia Gravis

Designation
11/14/2003 Sponsor and Address
Marketing Exclusivity Medica Venture Partners
Ackerstein Towers, Bldg B, 10th Floor
ISRAEL

ISRAEL
***************************************************************************************
Generic Name Approved Orphan Indication:
Monoclonal Ab(murine) anti-idiotype melanoma-
associated antigen

Trade Name:
Melimmune Orphan Designation:
Treatment of invasive cutaneous melanoma.

Designation
9/19/1994 Sponsor and Address
Marketing Exclusivity IDEC Pharmaceuticals Corporation
3030 Callan Road
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
Monoclonal antibodies (murine or human) to B-cell
lymphoma

Trade Name:
Orphan Designation:
Treatment of B-cell lymphoma.

Designation
5/6/1986 Sponsor and Address
Marketing Exclusivity IDEC Pharmaceuticals Corporation
11011 Torreyana Road
San Diego CA 92121

***************************************************************************************
Generic Name Approved Orphan Indication:
Monoclonal antibody 17-1a

Trade Name:
Panorex Orphan Designation:
Treatment of pancreatic cancer.

Designation
4/4/1988 Sponsor and Address
Marketing Exclusivity Centocor, Inc.
244 Great Valley Parkway
Malvern PA 19355

***************************************************************************************
Generic Name Approved Orphan Indication:
Monoclonal antibody for immunization against lupus
nephritis

Trade Name:
Orphan Designation:
Treatment of lupus nephritis.

Designation
1/7/1993 Sponsor and Address
Marketing Exclusivity VivoRx Autoimmune, Inc.
2825 Santa Monica Blvd., Suite 200
Santa Monica CA 90404

***************************************************************************************
Generic Name Approved Orphan Indication:
Monoclonal antibody to cytomegalovirus (human)

Trade Name:
Orphan Designation:
Treatment of cytomegalovirus retinitis in patients with AIDS.

Designation
11/15/1991 Sponsor and Address
Marketing Exclusivity Protein Design Labs, Inc.
2375 Garcia Avenue
Mountain View CA 94043

***************************************************************************************
Generic Name Approved Orphan Indication:
Monoclonal antibody to cytomegalovirus (human)

Trade Name:
Orphan Designation:
Prophylaxis of cytomegalovirus disease in patients undergoing solid
organ transplantation.
Designation
9/13/1991 Sponsor and Address
Marketing Exclusivity Protein Design Labs, Inc.
2375 Garcia Avenue
Mountain View CA 94043

***************************************************************************************
Generic Name Approved Orphan Indication:
Monoclonal antibody to hepatitis B virus (human)

Trade Name:
Orphan Designation:
Prophylaxis of hepatitis B reinfection in patients undergoing liver
transplantation secondary to end-stage chronic hepatitis B infection.
Designation
6/17/1991 Sponsor and Address
Marketing Exclusivity Protein Design Labs, Inc.
34801 Campus Dr.
Fremont CA 94555

***************************************************************************************
Generic Name Approved Orphan Indication:
Monoclonal antibody-B43.13

Trade Name:
Ovarex MAb-B43.13 Orphan Designation:
Treatment of epithelial ovarian cancer.

Designation
11/25/1996 Sponsor and Address
Marketing Exclusivity Unither Pharmaceuticals. Inc.
15 Walnut Street
Suite 300
Wellesley Hills MA 02481
***************************************************************************************
Generic Name Approved Orphan Indication:
Monoclonal antiendotoxin antibody XMMEn-0e5

Trade Name:
Orphan Designation:
Treatment of patients with gram-negative sepsis which has progressed
to shock.
Designation
11/4/1985 Sponsor and Address
Marketing Exclusivity Pfizer, Inc.
235 East 42nd Street
New York NY 10017

***************************************************************************************
Generic Name Approved Orphan Indication:
Monolaurin

Trade Name:
Glylorin Orphan Designation:
Treatment of congenital primary ichthyosis.

Designation
4/29/1993 Sponsor and Address
Marketing Exclusivity Glaxo Wellcome Inc.
5 Moore Drive
PO Box 13398
Research Triangle Park NC 27709
***************************************************************************************
Generic Name Approved Orphan Indication:
Monooctanoin

Trade Name:
Moctanin Orphan Designation:
For dissolution of cholesterol gallstones retained in the common bile
duct.
Designation
5/30/1984 Sponsor and Address
Marketing Exclusivity Ethitek Pharmaceuticals, Inc.
10/31/1985 7855 Gross Point Road, Unit L
Skokie IL 60077

***************************************************************************************
Generic Name Approved Orphan Indication:
Morphine sulfate concentrate (preservative free) For intrathecal or epidural infusion in the treatment of tractable
chronic pain. It was developed for use in continuous microinfusion
devices and may require dilution before use as directed.
Trade Name:
Infumorph Orphan Designation:
For use in microinfusion devices for intraspinal administration in the
treatment of intractable chronic pain.
Designation
7/12/1990 Sponsor and Address
Marketing Exclusivity Elkins-Sinn, Inc.
7/19/1991 2 Esterbrook Lane
Cherry Hill NJ 08003

***************************************************************************************
Generic Name Approved Orphan Indication:
motexafin gadolinium

Trade Name:
Xcytrin Orphan Designation:
For use in conjunction with whole brain radiation for the treatment of
brain metastases arising from solid tumors
Designation
1/27/2003 Sponsor and Address
Marketing Exclusivity Pharmacyclics, Inc.
999 East Arques Avenue
Sunnyvale CA 94085-4521

***************************************************************************************
Generic Name Approved Orphan Indication:
MTC-DOX for Injection

Trade Name:
Orphan Designation:
Treatment of hepatocellular carcinoma

Designation
1/3/2001 Sponsor and Address
Marketing Exclusivity FeRx Incorporated
4330 La Jolla Village Drive
Suite #250
San Diego CA 92122
***************************************************************************************
Generic Name Approved Orphan Indication:
Mucoid exopolysaccharide Pseudomonas
hyperimmune globulin

Trade Name:
MEP IGIV Orphan Designation:
Treatment of pulmonary infections due to Pseudomonas aeruginosa
in patients with cystic fibrosis.
Designation
1/9/1991 Sponsor and Address
Marketing Exclusivity North American Biologicals, Inc.
12280 Wilkins Avenue
Rockville MD 20852

***************************************************************************************
Generic Name Approved Orphan Indication:
Mucoid exopolysaccharide Pseudomonas
hyperimmune globulin

Trade Name:
MEP IGIV Orphan Designation:
Prevention of pulmonary infections due to Pseudomonas aeruginosa
in patients with cystic fibrosis.
Designation
11/7/1990 Sponsor and Address
Marketing Exclusivity North American Biologicals, Inc.
12280 Wilkins Avenue
Rockville MD 20852

***************************************************************************************
Generic Name Approved Orphan Indication:
Multi-ligand somatostatin analogue

Trade Name:
Orphan Designation:
Treatment of patients with functional gastroenteropancreatic (GEP)
neuroendocrine tumors (specifically, carcinoid, insulinoma,
Designation gastrinoma, somastatinoma, GRFoma, VIPoma and glucagonoma.
7/27/2004 Sponsor and Address
Marketing Exclusivity Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover NJ 07936-1080

***************************************************************************************
Generic Name Approved Orphan Indication:
Multi-vitamin infusion (neonatal formula)

Trade Name:
Orphan Designation:
For establishment and maintenance of total parenteral nutrition in
very low birth weight infants.
Designation
12/12/1989 Sponsor and Address
Marketing Exclusivity Astra Pharmaceuticals, L.P.
725 Chesterbrook Blvd.
Wayne PA 19087-5677

***************************************************************************************
Generic Name Approved Orphan Indication:
multi-vitiam infusion without vitamin K Prevention of vitamin deficiency and thrombormbolic complications
in people receiving home parenteral nutrition who also receive
warfarin-type anticoagulant therapy
Trade Name:
M.V.I.-12 Orphan Designation:
Prevention of vitamin deficiency and thromboembolic complications

Designation in people receiving home parenteral nutrition and warfarin-type


3/8/2004 Sponsor and Address anticoagulant therapy
Marketing Exclusivity Mayne Pharma (USA) Inc.
9/9/2004 Mack-Cali Centre II
Second Floor
Paramus NJ 07652
***************************************************************************************
Generic Name Approved Orphan Indication:
Murine MAb (Lym-1) and Iodine 131-I radiolabeled
murine MAb (Lym-1) to human B-cell lymphoma

Trade Name:
Oncolym Orphan Designation:
Treatment of B-cell non-Hodgkin's lymphoma.

Designation
11/27/1998 Sponsor and Address
Marketing Exclusivity Peregrine Pharmaceuticals, Inc.
14272 Franklin Ave.
Suite 100
Tustin CA 92780
***************************************************************************************
Generic Name Approved Orphan Indication:
Murine MAb to polymorphic epithelial mucin, human
milk fat globule 1

Trade Name:
Theragyn Orphan Designation:
Adjuvant treatment of ovarian cancer.

Designation
3/22/1999 Sponsor and Address
Marketing Exclusivity Antisoma plc
West Africa House
Hanger Lane Ealing
London W5 3QR
UNITED KINGDOM
***************************************************************************************
Generic Name Approved Orphan Indication:
Mx-dnG1 or Rexin-G retroviral vector

Trade Name:
REXIN-G Orphan Designation:
Treatment of pancreatic cancer

Designation
8/15/2003 Sponsor and Address
Marketing Exclusivity Epeius Biotechnologies Corporation
345 Pioneer Drive, 1803W
Glendale CA 91203

***************************************************************************************
Generic Name Approved Orphan Indication:
Mycobacterium avium sensitin RS-10

Trade Name:
Orphan Designation:
For use in the diagnosis of invasive Mycobacterium avium disease in
immunocompetent individuals.
Designation
10/11/1995 Sponsor and Address
Marketing Exclusivity Statens Seruminstitut
5 Artillerivej
DK-2300 Copenhagen S

SWEDEN
***************************************************************************************
Generic Name Approved Orphan Indication:
Mycophenolate mofetil

Trade Name:
Cellcept Orphan Designation:
Treatment of myasthenia gravis

Designation
12/19/2005 Sponsor and Address
Marketing Exclusivity Hoffman-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Mycophenolate mofetil

Trade Name:
CellCept Orphan Designation:
Treatment of pemphigus vulgaris

Designation
5/26/2006 Sponsor and Address
Marketing Exclusivity Hoffman-La Roche, Inc.
340 Kingsland Street
Nutley NJ 07110

***************************************************************************************
Generic Name Approved Orphan Indication:
Myelin

Trade Name:
Orphan Designation:
Treatment of multiple sclerosis.

Designation
6/27/1991 Sponsor and Address
Marketing Exclusivity AutoImmune, Inc.
128 Spring Street
Lexington MA 02173

***************************************************************************************
Generic Name Approved Orphan Indication:
myo-inositol

Trade Name:
Orphan Designation:
Prevention of retinopathy of prematurity in preterm infants at risk for
developing retinopathy of prematurity
Designation
4/7/2005 Sponsor and Address
Marketing Exclusivity Ross Products Division
Abbott Laboratories
625 Cleveland Ave.
Columbus OH 43215-1724
***************************************************************************************
Generic Name Approved Orphan Indication:
myristoylated recombinant SCR1-3 of human
complement reseptor type I

Trade Name:
APT070 Orphan Designation:
Prevention of delayed graft function in solid organ transplant

Designation
5/21/2003 Sponsor and Address
Marketing Exclusivity Inflazyme Pharmaceuticals, Ltd.
5600 Parkwood Way
Suite 425

CANADA
***************************************************************************************
Generic Name Approved Orphan Indication:
N-((methyl-diazacyclohexyl-methylbenzamide)-
asaphenyl-aminothiopyrrole) mesylate

Trade Name:
Orphan Designation:
Treatment of malignant gastrointestinal stromal tumors.

Designation
4/20/2005 Sponsor and Address
Marketing Exclusivity AB Science
3, avenue George V

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
N-(2,3-dihydro-3,3-dimethyl-1H-indol-6-yl)-2-[(4-
pyridinylmethyl)amino]-3-pyridinecarboxamide,
phosphate (1:2)

Trade Name:
Orphan Designation:
Treatment of gastrointestinal stromal tumors

Designation
1/13/2005 Sponsor and Address
Marketing Exclusivity Amgen, Inc.
One Amgen Center Drive
Thousand Oaks CA 91320-1799

***************************************************************************************
Generic Name Approved Orphan Indication:
N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-
oxoquinoline-3-carboxamide

Trade Name:
Orphan Designation:
Treatment of patients with cystic fibrosis.

Designation
12/20/2006 Sponsor and Address
Marketing Exclusivity Vertex Pharmaceuticals, Inc.
130 Waverly St.
Cambridge MA 02139-4242

***************************************************************************************
Generic Name Approved Orphan Indication:
N-(2-amino-phenyl)-4-[(4-pyridin-3-yl-pyrimidin-2-
ylamino)-methyl] benzamide dihydrobromide

Trade Name:
Orphan Designation:
Treatment of Hodgkin's lymphoma

Designation
8/8/2007 Sponsor and Address
Marketing Exclusivity Pharmion Corporation
2525 - 28th Street
Boulder CO 80301

***************************************************************************************
Generic Name Approved Orphan Indication:
N-(methyl-diazacyclohexyl-methylbenzamide)-
azaphenyl-aminothiopyrrole) mesylate

Trade Name:
Orphan Designation:
Treatment of multiple myeloma.

Designation
10/17/2005 Sponsor and Address
Marketing Exclusivity AB Science
3, avenue George V

FRANCE
***************************************************************************************
Generic Name Approved Orphan Indication:
N-[2-[(4-hydroxyphenyl)amino]-3-pyridinyl]-4-
methoxybenzenesulfonamide

Trade Name:
Orphan Designation:
Treatment of neuroblastoma

Designation
9/30/2004 Sponsor and Address
Marketing Exclusivity Abbott Laboratories
Pharmaceuticals Products Division
D-491, AP30-1E
Abbott Park IL 60064-6157
***************************************************************************************
Generic Name Approved Orphan Indication:
N-[3-(4',5'-bipyrimidin-2-ylamino)-4-methylphenyl]-4-
{[(3S)-3-(dimethylamino)pyrrolidin-1-yl]methyl}-3-
(trifluoromethyl)benzamide

Trade Name:
Orphan Designation:
Treatment of Philadelphia chromosome-positive chronic
myelogenous leukemia.
Designation
12/27/2006 Sponsor and Address
Marketing Exclusivity Innovive Pharmaceuticals
555 Madison Avenue
New York NY 10022

***************************************************************************************
Generic Name Approved Orphan Indication:
N-[4-(3-amino1H-indazol-4-yl)phenyl]-N1-(2-fluoro-5-
methylphenyl)urea

Trade Name:
Orphan Designation:
Treatment of hepatocellular carcinoma

Designation
5/23/2007 Sponsor and Address
Marketing Exclusivity Abbott Laboratories
Global Pharmaceuticals Research & Development
Abbott Park IL 60064

***************************************************************************************
Generic Name Approved Orphan Indication:
N-[4-(4-amino-2-ethyl-1H-imidazo[4,5-c]quinolin-1-
yl)butyl]methanesulfonamide

Trade Name:
Orphan Designation:
Treatment of stages IIB-IV melanoma

Designation
8/13/2004 Sponsor and Address
Marketing Exclusivity Coley Pharmaceuticals Group, Inc.
93 Worcester Street
Suite 101
Wellesley MA 02481
***************************************************************************************
Generic Name Approved Orphan Indication:
N-[4-(4-amino-2-ethyl-lH-imidazo[4,5-c]quinolin-1-
yl)butyl]methanesulfonamide

Trade Name:
Orphan Designation:
Treatment of cutaneous T-cell lymphoma

Designation
3/24/2006 Sponsor and Address
Marketing Exclusivity Coley Pharmaceuticals Group, Inc.
93 Worcester Street
Suite 101
Wellesley MA 02481
***************************************************************************************
Generic Name Approved Orphan Indication:
N-[4-bromo-2-(1H-1,2,3,4-tetrazol-5-yl)phenyl]-N'-[3,5-
bis(trifluoromethyl)phenyl]urea

Trade Name:
Orphan Designation:
Treatment of sickle cell disease

Designation
5/13/2002 Sponsor and Address
Marketing Exclusivity NeuroSearch A/S
93 Pederstrupvej
DK-2750 Ballerup

DENMARK
***************************************************************************************
Generic Name Approved Orphan Indication:
N-acetylcysteinate Lysine

Trade Name:
Nacystelyn Dry Powder Inhaler Orphan Designation:
For the management of cystic fibrosis

Designation
12/27/2000 Sponsor and Address
Marketing Exclusivity Galephar Pharmaceutical Research, Inc.
Road 198, No. 100 km. 14.7
Juncos Industrial Park
Juncos UN 00777-3873
PUERTO RICO
***************************************************************************************
Generic Name Approved Orphan Indication:
N-acetylcysteine

Trade Name:
Orphan Designation:
Treatment of acute liver failure

Designation
9/9/2002 Sponsor and Address
Marketing Exclusivity William M. Lee, MD, FACP
University of Texas Southwestern Medical Center at
5323 Harry Hines Blvd
Dallas TX 75390-9151
***************************************************************************************
Generic Name Approved Orphan Indication:
N-acetylgalactosamine-4-sulfatase, recombinant For patients with mucopolysaccharidosis VI. Galsulfase has been
human shown to improve walking and stair-climbing capacity.

Trade Name:
Naglazyme Orphan Designation:
Treatment of mucopolysaccharidosis Type VI (Maroteaux-Lamy
syndrome).
Designation
2/17/1999 Sponsor and Address
Marketing Exclusivity BioMarin Pharmaceutical, Inc.
5/31/2005 105 Digital Drive
Novato CA 94949-5608

***************************************************************************************
Generic Name Approved Orphan Indication:
N-acetyl-glucosamine thiazoline

Trade Name:
Orphan Designation:
Treatment of adult Tay-Sachs disease

Designation
2/6/2006 Sponsor and Address
Marketing Exclusivity ExSAR Corporation
11 Deer Park Drive
Monmouth Junction NJ 08852

***************************************************************************************
Generic Name Approved Orphan Indication:
N-acetylprocainamide

Trade Name:
Napa Orphan Designation:
To lower the defibrillation energy requirement sufficiently to allow
automatic implantable cardioverter defibrillator therapy in those
Designation patients who could otherwise not use the device.
3/23/1990 Sponsor and Address
Marketing Exclusivity Medco Research, Inc.
8455 Beverly Blvd.
Suite 308
Los Angeles CA 90048
***************************************************************************************
Generic Name Approved Orphan Indication:
N-acetyl-procainamide

Trade Name:
Orphan Designation:
Prevention of life-threatening ventricular arrhythmias in patients with