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EPIVIR Drug Profile

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

Epivir is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs.

The generic ingredient in EPIVIR 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

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

Summary for EPIVIR

US Patents:	0
Applicants:	2
NDAs:	4
Suppliers / Packagers:	1
Bulk Api Vendors:	118
Clinical Trials:	29
Patent Applications:	2,382
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EPIVIR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPIVIR
DailyMed Link:	EPIVIR at DailyMed

See drug prices for EPIVIR

Recent Clinical Trials for EPIVIR

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

Sponsor	Phase
Instituto de Investigación Hospital Universitario La Paz	Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Gilead Sciences	Phase 1/Phase 2

See all EPIVIR clinical trials

Recent Litigation for EPIVIR

Identify potential future generic entrants

District Court Litigation

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

See all EPIVIR litigation

Pharmacology for EPIVIR

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

.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 (TN)

Epivir-HBV

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	AA	RX	Yes	Yes
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998		RX	Yes	Yes
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	AB	RX	Yes	No
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	AB	RX	Yes	Yes

Expired US Patents for EPIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002