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EPIVIR Drug Profile

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Which patents cover Epivir, and when can generic versions of Epivir launch?

Epivir is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs. There is one patent protecting this drug and three Paragraph IV challenges.

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

Summary for EPIVIR

US Patents:	1
Applicants:	2
NDAs:	4
Suppliers / Packagers:	5
Bulk Api Vendors:	112
Clinical Trials:	28
Patent Applications:	2,199
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

Pharmacology for EPIVIR

Ingredient-type	Nucleoside Analog
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

Medical Subject Heading (MeSH) Categories for EPIVIR

Anti-HIV Agents

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

(-)-B-L-2',3'-DIDEOXY-3'-THIACYTIDINE

(-)-BCH 189

(-)-BCH-189

(-)-beta-L-2',3'-Dideoxy-3'-thiacytidine

(-)-NGPB-21

(-)-SddC

(-)NGPB-21

(+/-) (Cis)-1-[2-(Hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine

(+/-)-(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

(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'-deoxy-3'-thiacytidine

2',3' Dideoxy 3' thiacytidine

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)

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], (-)(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)

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

3TC, Zeffix, Heptovir, Epivir, Epivir-HBV, Lamivudine

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-((2R,5S)-2-hydroxymethyl-[1,3]oxathiolan-5-yl)-1H-pyrimidin-2-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

BCH189

BDBM50366817

Beta-L-(-)-2',3'-dideoxy-3'-thiacytidine & Sho-Saiko-To

beta-L-2',3'-Dideoxy-3'-thiacytidine

beta-L-3'-Thia-2',3'-dideoxycytidine

BIDD:GT0033

Bio-0652

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

D07TQV

D0V7DY

DB00709

DR000485

DRG-0126

DTHC

Efavirenz/lamivudine/tenofovir fumarate

Epivir (TN)

Epivir-HBV

Epivir-HBV (TN)

Epivir(TM)

FT-0082667

FT-0601626

FT-0650554

GG-714

GR 109714X

GR-109714X

GR109714X

Hepitec

Heptivir

Heptodin

Heptovir

Heptovir (TN)

HHA & 3TC

HHA & Lamivudine

HMS2051D21

HMS3259F08

HSDB 7155

HY-B0250

J-700183

J10244

JTEGQNOMFQHVDC-NKWVEPMBSA-N

KB-239893

KS-0000023D

KS-1073

L-SDDC

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, (2S-cis)-Isomer

Lamivudine, >=98% (HPLC), powder

Lamivudine, 1.0 mg/mL in methanol, certified reference material

Lamivudine, European Pharmacopoeia (EP) Reference Standard

Lamivudine, pharmaceutical secondary standard; traceable to USP, PhEur and BP

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

NU000182

NU006541

PYR356

Q-201275

RL01569

RTC-020973

s1706

SAM001246582

SAM002589994

SBB066293

SC-15184

SCHEMBL109675

SMR000466319

ST24030826

STK801940

UNII-2T8Q726O95

VIROLAM

ZB000700

Zeffix

Zeffix (TN)

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					Y
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998		RX	Yes	Yes					Y
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
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	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	SOLUTION;ORAL	020596-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995
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

Paragraph IV (Patent) Challenges for EPIVIR

Drugname	Dosage	Strength	RLD	Date
	Tablets	100 mg
	Tablets	150 mg and 300 mg
	Oral Solution	10 mg/mL

International Patents for EPIVIR

Country	Document Number	Estimated Expiration
Hungary	225600
Canada	2286126
El Salvador	1998000040
Poland	336038
Honduras	1998000045
Iceland	5184

Supplementary Protection Certificates for EPIVIR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0035	Belgium		PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228
C/GB98/019	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318
80018	Netherlands		PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
C0020	Belgium		PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
C/GB96/043	United Kingdom		PRODUCT NAME: LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH 53662 19960228; CH 53663 19960228; UK EU/1/96/015/001 19960808; UK EU/1/96/015/002 19960808