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EPIVIR-HBV Drug Profile

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Which patents cover Epivir-hbv, and what generic alternatives are available?

Epivir-hbv is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in EPIVIR-HBV is lamivudine. There are twenty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the lamivudine profile page.

US ANDA Litigation and Generic Entry Outlook for Epivir-hbv

A generic version of EPIVIR-HBV was approved as lamivudine by AUROBINDO PHARMA LTD on November 17^th, 2011.

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Summary for EPIVIR-HBV

US Patents:	0
Applicants:	1
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	118
Clinical Trials:	29
Patent Applications:	2,382
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EPIVIR-HBV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPIVIR-HBV
DailyMed Link:	EPIVIR-HBV at DailyMed

Drug patent expirations by year for EPIVIR-HBV

Recent Clinical Trials for EPIVIR-HBV

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Instituto de Investigación Hospital Universitario La Paz	Phase 2
GlaxoSmithKline	Phase 1/Phase 2
University of Michigan Cancer Center	Phase 1/Phase 2

See all EPIVIR-HBV clinical trials

Recent Litigation for EPIVIR-HBV

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Glaxo Group Ltd. v. Lupin Ltd.	2008-08-29

See all EPIVIR-HBV litigation

Pharmacology for EPIVIR-HBV

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Synonyms for EPIVIR-HBV

.beta.-L-(-)-2',3'-dideoxy-3'-thiacytidine & Sho-Saiko-To
(-)-(2'R,5'S)-1-[2'-Hydroxymethyl-5'-(1,3-oxathiolanyl)]cytosine
(-)-1-((2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine
(-)-1-[(2R,5S)-2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
(-)-2'-Deoxy-3'-thiacytidine
(-)-BCH 189
(-)-BCH-189
(-)-L-2',3'-DIDEOXY-3'-THIACYTIDINE; LAMIVUDINE; EPIVIR
(-)-SddC
(-)NGPB-21
(+/-) (Cis)-1-[2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
(+/-)-(cis)-4-Amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one
(+/-)-3TC
(+/-)-BCH-189
(+/-)-SddC
(2R,5S)-1-[2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine
(2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one
1117764-41-6
134678-17-4
136891-12-8
2',3'-Dideoxy-3'-thiacytidine
2(1H)-Pyrimidinone, 4-amino-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-
2(1H)-Pyrimidinone, 4-amino-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, (2R-cis)-
2(1H)-Pyrimidinone, 4-amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-
2(1H)-Pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (-)(2R,5S) & Galanthus Nivalis Agglutinin (GNA)
2(1H)-Pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (-)(2R,5S) & Hippeastrum hybrid agglutinin( HHA)
2(1H)-Pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (+/-) (Cis)
200973-EP2272825A2
24222-EP2269989A1
24222-EP2272516A2
24222-EP2272825A2
24222-EP2292227A2
24222-EP2298761A1
24222-EP2298783A1
24222-EP2305243A1
24222-EP2305640A2
24222-EP2305680A2
24222-EP2314590A1
2T8Q726O95
3-[(5S,2R)-2-(hydroxymethyl)(1,3-oxathiolan-5-yl)]-6-amino-3-hydropyrimidin-2- one
3'-Thia-2',3'-dideoxycytidine
3TC
3TC (AIDS INITIATIVE) (AIDS INITIATIVE)
3TC & GNA
3TC & SST
3TC and NV-01
4-Amino-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1H)-pyrimidinone
4-amino-1-((2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one
4-Amino-1-(cis-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one
4-amino-1-[(2R,5S)-2-(hydroxymethyl)-[1,3]-oxathiolan-5-yl]-(1H)-pyrimidin-2-one
4-amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-Oxathiolan-5-yl]-(1H)-pyrimidin-2-one
4-AMINO-1-[(2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL]-1,2-DIHYDROPYRIMIDIN-2-ONE
4-AMINO-1-[(2R,5S)-2-(HYDROXYMETHYL)-1,3-OXATHIOLAN-5-YL]-2(1H)-PYRIMIDINONE
4-amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2-one
4-amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1H)-one
480434-79-5
678L174
AB00639995_09
AB00639995-06
AB00639995-08
AB07588
AC-1416
AC1L1TZZ
AC1Q6C34
AJ-08348
AK105888
AK481424
AKOS005622556
AKOS015854841
AN-7245
ANW-43098
BBL033871
BC206089
BCH 189
BCH 189, (-)-
BCH-189
BCH-790
BDBM50366817
beta-L-2',3'-Dideoxy-3'-thiacytidine
beta-L-3'-Thia-2',3'-dideoxycytidine
BIDD:GT0033
C07065
C8H11N3O3S
CCG-100984
CCRIS 9274
CHEBI:63577
CHEMBL141
CIS-LAMIVUDINE
cis(+/-)-4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidinone
CJ-00130
CPD000466319
CS-2230
CTK3J2124
D00353
DB00709
DRG-0126
DTHC
Epivir
Epivir (TN)
Epivir(TM)
FT-0082667
FT-0601626
FT-0650554
GG-714
GR 109714X
GR-109714X
GR109714X
Hepitec
Heptivir
Heptodin
Heptovir
HHA & 3TC
HHA & Lamivudine
HMS2051D21
HMS3259F08
HMS3713C16
HSDB 7155
HY-B0250
J-700183
J10244
JTEGQNOMFQHVDC-NKWVEPMBSA-N
KB-239893
KS-0000023D
KS-1073
L0217
Lamivir
Lamivudin
Lamivudina
lamivudine
Lamivudine (EPIVIR)
Lamivudine (JAN/USP/INN)
Lamivudine [USAN:BAN:INN]
Lamivudine [USAN:INN:BAN]
Lamivudine [USAN:USP:INN:BAN]
Lamivudine & GNA
lamivudine & TNF-alpha & IFN-gamma
Lamivudine for system suitability 1, European Pharmacopoeia (EP) Reference Standard
Lamivudine for system suitability 2, European Pharmacopoeia (EP) Reference Standard
Lamivudine, >=98% (HPLC), powder
Lamivudine, 1.0 mg/mL in methanol, certified reference material
Lamivudine, 98%
Lamivudine, British Pharmacopoeia (BP) Reference Standard
Lamivudine, European Pharmacopoeia (EP) Reference Standard
Lamivudine, Pharmaceutical Secondary Standard; Certified Reference Material
Lamivudine, United States Pharmacopeia (USP) Reference Standard
Lamivudinum
LMV
LS-2107
M-9795
MCULE-2096184994
MFCD00869739
MLS000759424
MLS001424097
MLS006011910
MolPort-002-507-347
NC00234
NC00705
NCGC00159341-04
NCGC00159341-05
NSC620753
PYR356
Q-201275
RL01569
RTC-020973
s1706
SAM001246582
SAM002589994
SBB066293
SC-15184
SCHEMBL109675
SMR000466319
SR-01000759420
SR-01000759420-5
ST24030826
STK801940
SW197614-3
UNII-2T8Q726O95
ZB000700
Zeffix
Zefix
ZINC12346

US Patents and Regulatory Information for EPIVIR-HBV

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	AB	RX	Yes	Yes	Start Trial	Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for EPIVIR-HBV

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	Start Trial	Start Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	Start Trial	Start Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	Start Trial	Start Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	Start Trial	Start Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	Start Trial	Start Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	Start Trial	Start Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration