P. 1
para 4 ANDA filings in 2010

para 4 ANDA filings in 2010

|Views: 45|Likes:
Published by Brain League

More info:

Published by: Brain League on Mar 16, 2011
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as XLSX, PDF, TXT or read online from Scribd
See more
See less

03/16/2011

pdf

text

original

No.

DRUG NAME BRAND NAME NDA APPLICANT
1 Adefovir Dipivoxil HEPSERA GILEAD
2 Atazanavir Sulfate REYAA!
"
# $i%atopro&t LAISSE ALLERGAN
' $ude&onide ASRA!ENE(A
) A(L*NE+ LE* PHAR,
- (larit.ro%/0in $IA+IN +L A$$*
1 (lo2eta&ol Propionate *L3+ E SIE4EL LA$S IN(
5 (ole&evela% H/dro0.loride6EL(H*L DAII(HI SAN7Y*
18 Darunavir Et.anolate PRE!ISA I$*E(
11 Da&atini2 SPRY(EL
12 Dexlan&oprazole DE+ILAN A7EDA PHAR,S
1" 4*(ALIN +R N*9ARIS
1# Donepezil H/dro0.loride ARI(EP *D EISAI IN(
1' Doxepin H/dro0.loride SILEN*R S*,A+*N
$RIS*L ,YERS
S:3I$$
Atova;uone and Pro<uanil
H/dro0.loride
,ALAR*NE
PEDIARI(
GLA+*S,IH7LIN
E
P3L,I(*R
RESP3LES
(al0ipotriene and
$eta%et.a&one
Dipropionate
$RIS*L ,YERS
S:3I$$
Dex%et./lp.enidate
H/dro0.loride
1) Doxer0al0iferol HE(*R*L GEN!Y,E
1- =ALYN
11 Eletriptan H/dro2ro%ide RELPA+ P4I!ER IRELAND
15 Ente0avir $ARA(L3DE
28 Epro&artan ,e&/late E9EEN A$$*
21 E&tradiol N*9ARIS
22 NAA!IA $AYER HLH(ARE
2" 4enofi2rate 4EN*GLIDE
2# 4exofenadine H/dro0.loride ALLEGRA
2' Gatifloxa0in !Y,A+ID ALLERGAN
2) H/dro0orti&one $ut/rate
2- E+ALG*
21 I2upofen L/&ine NE*PR*4EN L3ND$E(7 IN(
25 Lenalido%ide RE9LI,ID (ELGENE
"8 ,EHYLIN ,ALLIN(7R*D
"1 SALI+ PHAR,S
"2 ,ino0/0line H/dro0.loride S*L*DYN ,EDI(IS
Duta&teride and
a%&ulo&in H/dro0.loride
GLA+*S,IH7LIN
E
$RIS*L ,YERS
S:3I$$
9I9ELLE>D*
E&tradiol 9alerate and
Dieno<e&t
SHI*N*GI
PHAR,A
SAN*4I A9ENIS
3S
L*(*ID
LIP*(REA,
RIA+ PHAR,S
LL(
H/dro%orp.one
H/dro0.loride
,ALLIN(7R*D
IN(
,et./lp.enidate
H/dro0.loride
,eto0lopra%ide
H/dro0.loride
,E*!*L9
*D
"" 9I,*9* ASRA!ENE(A LP
"# Nia0in and Si%va&tatin SI,(*R A$$*
"' !e<erid *( S(HERING PL*3GH
") *&elta%ivir P.o&p.ate A,I4L3 R*(HE
"- *x/0odone H/dro0.loride *+Y(*NIN
"1 ,IRAPE+ ER
"5 *RAPRED *D
#8 Pre<a2lin LYRI(A P4I!ER
#1 Ranolazine RANE+A GILEAD
#2 Ra&a<iline ,e&/late A!ILE( E9A
#" Siroli%u& RAPA,3NE
## $RAINREE LA$S
#' Sodiu% *x/2ate +YRE, =A!!
#) Sita<liptin P.o&p.ate =AN39IA ,ER(7 (* IN(
Naproxen and
E&o%eprazole ,a<ne&iu%
*%eprazole and Sodiu%
$i0ar2onate
P3RD3E PHAR,A
LP
Pra%ipexole
Di./dro0.loride
$*EHRINGER
INGELHEI,
Predni&olone Sodiu%
P.o&p.ate
SHI*N*GI
PHAR,A
6YEH PHAR,S
IN(
Sodiu% Sulfate? Pota&&iu%
Sulfate and ,a<ne&iu%
Sulfate
S3PREP $*6EL
PREP 7I
#- =AN3,E ,ER(7
#1 Sunitini2 ,alate S3EN (PPI (9
#5 a0roli%u& PR**PI( ASELLAS
'8 9IREAD GILEAD
'1 razodone H/dro0.loride *LEPR* LA$*PHAR,
'2 retinoin REIN>A ,I(R*
'" 9areni0line artrate (HANI+ P4I!ER IN(
'# 9ori0onazole 94END P4I!ER
'' !olpide% artrate EDL3AR ,EDA PHAR,S
Sita<liptin P.o&p.ate and
,etfor%in H/dro0.loride
enofovir Di&oproxil
4u%arate
*RH*
DER,A*L*GI(S
RELATED PATENTS PATENT EXPIRY DATE
'))"1'5? )#'1"#8 Sept 2? 281#? =ul 2"? 2811
'1#5511? )81-"1" =une 28? 281-? De0 21? 2811
)818-11? )''1)1) Apr 11? 281- ? =ul 1'? 281-
)-"8211? -825)'5 Sep 1? 2815? Sep 1? 2815
'551##5? )1))8#)?
)251#11
Nov 2'? 281" ? Nov 2'? 281" ? Nov
2'? 281"
)#8")#5? -"'1#8#?
-"11825
Sept 21? 2812? ,a/ 2'? 282# ? =an
21? 2822
)'51)8"? )155855?
-'2#1"#
De0 2"? 2811 ? De0 2"? 2811 ? Nov
11? 2811
'-)"#2)? )-'"81"?
)-'"81"? RE"5-8)
=un 5? 281' ? =an 2-? 2828 ? =an 2-?
2828 ? =un 5? 281'
')8-))5? ')-5-1-?
')5")-'? '51-88-?
'5151"2? )8)))-1?
)#""82)? )-1#2'#?
-1815)8? -225)1"?
=un 18? 281#? Apr 25? 281# ? De0 2?
281#? Apr 25? 281#? Apr 25?
281# ? Apr 25? 281# ?Apr 25?
281# ? Apr 25? 281# ? Apr 25?
281#? Apr 1-? 2822
'1#"5#) ? '1#"5#) ?
'1#"5#) ? )8"-1'- ?
)2#1--' ? )""'#)8 ?
)""'#)8 ? )""'#)8 ?
)-8"#8" ? -#-8'8) ?
--88)#'
De0 1? 281' ? De0 1? 281' ? De0 1?
281' ? =un 2)? 281) ? Au< 1"? 281#
? Au< 2'? 2812 ? Au< 2'? 2812 ?
Au< 2'? 2812 ? =un 2)? 281) ? =un
2"? 2815 ? De0 2)? 282)
)'5)-#)? )'5)-#)?
-12'1-'? -12'1-'?
-1'"1')? -#51-2'
=un 21? 2828? =un 21? 2828? Apr 1"?
2828? Apr 1"? 2828? Apr 21? 2828?
,ar 21? 282)
)#)28'1? )#)28'1?
)#)28'1? )))#2-)?
)))#2-)? )))#2-)?
)5"55-1? )5"55-1?
)5"55-1? -21'))1?
--58-''
=un 1'? 2828? =un 1'? 2828? =un 1'?
2828? =un 1'? 2828 ? =un 1'? 2828?
=un 1'? 2828? =un 1'? 2828? =un 1'?
2828 ? =un 1'? 2828? =un 1'? 2828?
Au< 2? 282)?
'1"-21#? '5811'8?
)221"51? )"'')')?
)'21'"8? ))"'21#?
)-"8"2'? -#"15##
De0 #? 281'? De0 #? 281'? Nov 1?
2815? De0 #? 281'? De0 #? 281'?
De0 #? 281'? Nov 1? 2815? De0 #?
281'
#15'1#1? --2-'#1?
--2-''2
Nov 2'? 2818? =un 2"? 2822? ,ar
2)? 2811
''828#-? ''1'11'?
'-2'11#? '1))1))?
'5#1#"1? )18"215?
)211225? )21-585
,ar 2)? 281" ? =an 5? 281' ? =an 5?
281' ? =an 5? 281' ? =an 5? 281' ?
=an 5? 281' ? 4e2 1-? 2828 ? =an 5?
281'
')8211)? )58"81" 4e2 11? 281#? =ul 11? 2821
''#')##? )1185#8 De0 2)? 281)? Au< 25? 281-
'28)2## 4e2 21? 281'
')'))'8 Au< 12? 281#
-)'15## De0 5? 282#
'11821"? )"""8#'? De0 '? 281'? Au< 28? 2815
')"'#5- =un "? 281#
'-82-2'? '51#1"1 =ul - ? 281#? =ul - ? 281#
)"#2'"8? )"###-5 Nov 1#? 2828? ,ar 28? 2821
-)51118 *0t 8-? 282#
)#1"'#5 =ul 11? 281-
'5811"1? --58-8' 4e2 15? 2811? Nov 28? 282'
'')'#)-? '1#)5-) ?
'551#2-
Nov 28? 281' ? Sep 1-? 281" ? Sep
1-? 281"
'#-#-1"? ')')21)?
'5'1##)? )82#5-)
De0 12? 2812? Au< 12? 281#? De0
12? 2812? =an -? 281#
)1""2'1? )1""2'1?
)1""2'1? )11#-5"
*0t 2'? 281)? *0t 2'? 281)? *0t
2'? 281)? *0t 2'? 281)
''-1)18? )8"-"'"?
)11--51? )"55)"2?
-1"1'2#
Nov 2)? 281"? ,ar 1#? 2818? ,a/
11? 2812? ,a/ 11? 2812? ,a/ 11?
281#? Nov 11? 281#
')"''1-? )8#''81?
)2112"8? )"1'-28 ?
)'''''#? )')15-)?
)')15--? )-''-1# ?
)581#"2? -11518)?
-115-#8? -#)'188?
-1''21-
*0t #? 2815? Au< 21? 2811? =ul 2#?
281)? *0t 2"? 2828? =ul 2#? 281)?
Au< 21? 2811? *0t 2"? 2828? *0t
2"? 2828? Au< 21? 2811? =ul 2#?
281)? Apr 11? 282"? Apr 22? 282)?
Nov 2#? 282#
#11)112? -)5'-"# *0t 1? 2818? Apr 2)? 2821
)5#)1#5 Apr? "8? 2822
'-1#'8#? '588#2#?
)")581'? )1-'1-2?
)52)58-? -#118-8?
--#'#))
4e2 "? 281' ? ,a/ #? 281)? ,a/ 2'?
2811? ,a/ 2-? 281#? 4e2 21? 282"?
,a/ 2'? 2811 ? *0t 1"? 2811
)818#21? )1255"8?
)#8)-1'? )#)58"'?
))-)5)-? )-#))51?
)111225? -8111#1
,a/ 2-? 281-? Sep 28? 281"? Sep
28? 281"? ,ar 1'? 2811? Sep 28?
281"? Sep 28? 281" ? Sep 28?
281"? Sep 28? 281"
)#15"#)? ))#'511?
))5511'? -"55--2
=ul 1' ? 281)? =ul 1' ? 281)? =ul 1' ?
281)? =ul 1' ? 281)
'-)"#1"? '1)))81?
'5'2"-'?
De0 2-? 281) ? 4e2 2? 281) ? 4e2 2?
281)
''818#2? )#115)"?
-)-#-55? -)-#188?
-)1"8-2? ---)"1#
Apr 1)? 281"? =un 2#? 281-? ,ar
"8? 282'? ,ar "8? 282'? ,ar "8?
282'? Apr 15? 282'
)82#511? )221"52?
)-#8"#1
Apr 5? 2811? Apr 5? 2811? Nov 2#?
2815
'')"1-'? )8811-)?
)8811-)? )15-115?
RE#1528
*0t 1? 281"? De0 "8? 2811? De0 "8?
2811? De0 "8? 2811? De0 "8? 2811
)"8")8-? )")58)2?
)#-5#5)? )'8"511?
)'2'8'-? )')212)?
))1-"21? ))2811#?
)1'2-2#? )1)#2'1
,a/ 2-? 2815? ,a/ 2-? 2815? ,a/
2-? 2815? ,a/ 2-? 2815? ,a/ 2-?
2815? ,a/ 2-? 2815? ,a/ 2-?
2815? ,a/ 2-? 2815? ,a/ 2-?
2815? ,a/ 2-? 2815
'"1-)12? '#'"##)?
'#'-1""? ''"2#1'?
'-1)"58? )12)5)1?
-'-21"#? -11'5#2
4e2 - ? 2812? 4e2 - ? 281-? 4e2 - ?
2812? =ul 2 ? 281"? 4e2 - ? 2812?
Sep 11 ? 281)? De0 ' ? 282)? Au<
2- ? 282-
'188155? '1#')1#?
'#8"1""? '515'51
=ul -? 281"? =an 2' ? 2811? Apr # ?
2812? ,ar 11 ? 2811
)-18115? -2)2215?
-))1-"8? --)'18)?
--)'18-? -1'1'8)?
-1'1'8)? -15'8'5
=ul #? 2828? =ul #? 2828? ,ar -?
282# ? =un 1)? 282# ? =un 1)? 282#?
De0 22? 2815? De0 22? 2815? De0
1-? 2822
)"8"))1? ))551-1?
)158151? )158151?
)158151? -8-1"11?
-8-1"11? -8-1"11?
-8-1"11? -12'1-"?
-12'1-"? -12'1-"?
-12'1-"? -"2)-81
Apr 2# ? 281-? =ul 2) ? 2822? 4e2
2 ? 2815? 4e2 2 ? 2815? 4e2 2 ?
2815? 4e2 2 ? 2815? 4e2 2 ? 2815?
4e2 2 ? 2815? 4e2 2 ? 2815? =ul 2) ?
2822? =ul 2) ? 2822? =ul 2) ? 2822?
=ul 2) ? 2822? Apr 11? 282)
'"1'58-? '))'-2- =an "1? 2812? Sep 5? 281#
))8--#1? -125128 =un 25? 2828? ,ar 2-? 282-
'5''185 Sept 21? 281)
)-)1518 Sept 2#? 2815
)"8"))1? ))551-1?
)158151? )158151?
)158151? -8-1"11?
-8-1"11? -8-1"11?
-12'1-"? -12'1-"?
-12'1-"? -"2)-81
Apr 2# ? 281-? =ul 2) ? 2822? 4e2
2 ? 2815? 4e2 2 ? 2815? 4e2 2 ?
2815? 4e2 2 ? 2815? 4e2 2 ? 2815?
4e2 2 ? 2815? =ul 2) ? 2822? =ul 2) ?
2822? =ul 2) ? 2822? Apr 11 ? 282)
)'-"25"? -12'58'?
-211)88
4e2 1'? 2821? 4e2 1'? 2821? De0
22? 2828
'522)5'? '522)5'?
'522)5'? '522)5'?
'5"'5#)? '5"'5#)?
'5"'5#)? '5"'5#)?
'5--815? '5--815?
'5--815? '5--815?
)8#"2"8? )8#"2"8?
)8#"2"8? )8#"2"8
=ul 2' ? 281-? =ul 2' ? 281-? =ul 2' ?
281-? =ul 2' ? 281-? =ul 2' ? 281-?
=ul 2' ? 281-? =ul 2' ? 281-? =ul 2' ?
281-? =ul 2' ? 281-? =ul 2' ? 281-?
=ul 2' ? 281-? =ul 2' ? 281-? =ul 2' ?
281-? =ul 2'? 281-? =ul 2' ? 281-?
=ul 2' ? 281-
)#18''8? )15852-?
-2)'115
,a/ 18? 2828? ,a/ )? 2822? Au< "?
2822
'")#5"1? '')-11-?
'--"##"
Nov 1'? 2811? ,a/ 2#? 281)? =an
2'? 2811

You're Reading a Free Preview

Download
scribd
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->