Drug Patent Expiration Table

Estimated Dates of Possible First Time Generic Prescription

to Over-the-Counter Market Entry
2008 US Retail
Year Period Brand Name Generic name Sales: (in millions)^
2010 1Q (Jan) Mirapex® pramipexole $344
2010 1Q (Feb) Aldara® imiquimod $375
2010 1Q(Mar) Astelin® azelastine nasal spray $273
2010 2Q (Apr) Cozaar® losartan $731
2010 2Q (Apr) Hyzaar® losartan/ $548
hydrochlorothiazide
2010 2Q (Apr) Flomax® tamsulosin $1,318
2010 2Q (May) Epivir® lamivudine $91
2010 2Q (May) Aceon® perindopril $24
2010 3Q (Jul) Effexor® XR venlafaxine $2,791
2010 3Q (Jul) Arimidex®1 anastrozole $617
2010 3Q (Aug) Teveten® and Teveten® HCT eprosartan and Teveten: $10
eprosartan/ Teveten HCT: $8
hydrochlorothiazide
2010 3Q (Sep) Cardene® SR nicardipine sustained $2
release capsules
2010 4Q(Nov) Aricept® donepezil $1,224
2010 4Q (Dec) Differin® adapalene $282
2011 2Q (Apr) Accolate® zafirlukast $44
2011 2Q (Apr) Femara® letrozole $384
2011 3Q(Aug) Actos® pioglitazone $2,569
2011 3Q(Sep) Xalatan® latanoprost $494
2011 4Q (Oct) Zyprexa® olanzapine $1,853
2011 4Q(Nov) Caduet® amlodipine/ atorvastatin $418
2011 4Q(Nov) Lipitor® atorvastatin $6,392
2011 4Q(Dec) Tazorac® tazarotene $109
2012 1Q(Jan) Anzemet® dolasetron $11
2012 1Q (Jan) Levaquin® levofloxacin $1,719
2012 1Q (Mar) Lexapro®2 escitalopram $2,554
2012 1Q(Mar) Gabitril® tiagabine $60
2012 1Q(Mar) Avapro® irbesartan $405
2012 1Q(Mar) Avalide® irbesartan/ $351
hydrochlorothiazide
2012 1Q (Mar) Seroquel® quetiapine $3,236
2012 2Q (Apr) Avandia® rosiglitazone $536
2012 2Q (Apr) Avandamet® rosiglitazone/ metformin $217
2012 2Q (May) Plavix®3 clopidogrel $3,971
(approved 1/06 and briefly
launched 8/06)
2012 3Q(Jul) Clarinex® and Clarinex-D® desloratadine and Clarinex: $251
(planning OTC prior to generic desloratadine/ Clarinex D: $40
4
availability) pseudoephedrine
2012 3Q (Jul) Lunesta® eszopiclone $845
2012 3Q(Aug) Lovenox® enoxaparin $1,107
2012 3Q (Aug) Singulair® montelukast $3,204
2012 3Q (Sep) Diovan® and Diovan® HCT5 valsartan and valsartan/ Diovan: $1,369
hydrochlorothiazide Diovan HCT: $1,302
2012 3Q(Sep) Geodon® ziprasidone $875
2012 3Q (Sep) Detrol® tolterodine $43
2012 4Q (Nov) Viramune® nevirapine $110
2012 4Q (Nov) Combivir® lamivudine/zidovudine $312

1
 2008 US Retail
Year Period Brand Name Generic name Sales: (in millions)^
2012 4Q (Dec) Lescol® fluvastatin $42
2012 4Q (Dec) Atacand® and Atacand HCT® candesartan and Atacand: $162
candesartan/ Atacand HCT: $82
hydrochlorothiazide
2013 1Q (Jan) Evista® raloxifene $534
2013 2Q (May) Zomig® zolmitriptan Tablets: $165
ZMT: $34
Nasal: $25
2013 2Q (Jun) Fosamax Plus D™ alendronate / $240
cholecalciferol
2013 4Q (Oct) Eloxatin® oxaliplatin injection $6
2013 4Q (Nov) Aciphex® rabeprazole $1,159
(tablets approved but not
launched 2/07)
2013 4Q (Dec) Fuzeon® enfuvirtide injection $43
2013 4Q (Dec) Cymbalta® duloxetine $2,294
2014 1Q (Feb) Asacol® mesalamine delayed- $494
release tablet
2014 1Q (Mar) Avodart® dutasteride $389
2014 1Q (Mar) Advicor® lovastatin/niacin $106
2014 2Q (Apr) Viracept® nelfinavir $71
2014 2Q(Apr) Namenda® memantine $606
2014 2Q (May) Nexium® esomeprazole $5,080
2014 2Q (May) Celebrex® celecoxib $1,634
2014 2Q (Jun) Actonel®6 risedronate 35 mg: $765
5mg: $12
75 mg: $28
2014 3Q (Jul) Micardis® telmisartan $163
Micardis® HCT telmisartan/
hydrochlorothiazide
2014 3Q(Aug) Temodar® temozolomide $224
2014 3Q (Aug) Maxalt® rizatriptan $235 (does not
include MLT form)
2014 3Q (Aug) Exelon®7 rivastigmine $203
2014 3Q (Sep) Avelox® moxifloxacin $514
2014 4Q (Nov) Copaxone® glatiramer injection $391
2015 1Q (Jan) Cipro® HC ciprofloxacin/ $46
hydrocortisone otic
suspension
2015 1Q (Feb) Lumigan® bimatoprost ophthalmic $253
solution
2015 1Q (Mar) Sustiva® efavirenz $192
2015 1Q (Mar) Renagel® sevelamer $394
2015 2Q (Jun) Welchol® colesevelam $221
2015 2Q (Jun) Travatan® travoprost ophthalmic $120
solution
2015 4Q (Dec) Patanol® olopatadine solution $256
2016 3Q (Jul) Crestor® rosuvastatin calcium $1,849
2017 2Q (May) Relpax® eletriptan $231
2017 3Q (Jul) Byetta® exenatide injection $627
2017 4Q(Oct) Zetia® ezetimibe $1,232
2017 4Q (Oct) Vytorin® ezetimibe/simvastatin $1,635
2018 3Q (Jul) Spiriva® tiotropium powder for $1,191
inhalation
2018 4Q (Oct) Nasonex® mometasone nasal spray $1,045
2019 3Q (Jul) Lyrica® pregabalin $1,492
2020 2Q (May) Detrol® LA tolterodine $729
2021 3Q (Aug) Crixivan® indinavir $12

2
^ Dollar amount reflects combined sales of all strengths and formulations of the product, unless
otherwise indicated; source IMS Health
Changes since the last update are highlighted in yellow.
1
FDA granted an additional six-month period of exclusivity to market Arimidex for its licensed
breast cancer indications until June 2010. Prior to pediatric exclusivity being granted by the
FDA, the patent was due to expire in December 2009.
2
Lexapro’s '712 patent was originally slated to expire in December 2009, which included an
additional six months of pediatric exclusivity. The U.S. Patent & Trademark Office granted the
patent an 828-day extension in March 2006. Therefore, the estimated date for generic
availability changed to March 2012. A recent patent litigation decision has also sided with
Forest, upholding the validity of a key patent on Lexapro and keeping generics off the market
until patent expiration in 2012.
3
Generic Plavix was approved 1/20/06 with paragraph IV certification giving Apotex 180-day
exclusivity. Apotex launched their generic “at risk” on August 8, 2006. A preliminary
injunction was granted on August 31, ordering Apotex to halt its sales of generic Plavix. The
judge did not require Apotex to recall clopidogrel that had already been distributed. Bristol-
Myers Squibb/Sanofi’s patent infringement trial against Apotex began January 22, 2007.
4
Several companies have announced the settlement of patent litigation relating to Desloratadine
Tablets, 5 mg (Clarinex). Pursuant to these settlements, the generic manufacturers will have the
right to market Desloratadine Tablets, 5 mg, in the U.S. on July 1, 2012, or earlier in certain
circumstances. Clarinex and Clarinex D will likely be switched to OTC availability prior to
generic availability.
5
Diovan received pediatric exclusivity, extending the drug's patent protection in the US until
September 2012.
6
In October 2007, Teva received FDA approval of its ANDA for Actonel 5 mg, 30 mg, and 35
mg tablets but did not launch due to ongoing patent litigation. In February 2008, the U.S.
District Court for the District of Delaware found Procter & Gamble’s U.S. Patent No.
5,538,122 covering Actonel to be valid. Teva intends to appeal this decision.
7
In late 2007 to early 2008, three generics manufacturers received final approval from the FDA
for their generic Exelon capsules. The manufacturers entered into settlement agreements with
Novartis. Under the terms of the agreements, they will not launch generic Rivastigmine
Tartrate capsules until sometime before the expiry of the Orange Book patents. The exact date
of launch and other terms of the agreements are confidential.

Note: Pulmicort dry powder inhalation and Advair have been removed from the table. Both
contain inhaled corticosteroids, and the FDA has not determined a standard for
bioequivalence for inhaled corticosteroids in multi-dose inhalers (MDIs) or dry powder
inhalers (DPIs). Therefore, generic availability may be significantly delayed. At this time,
there is no estimated date of generic approval.

Source: ©2009 Medco Health Solutions, Inc. All rights reserved.