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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. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty-six patent family members in forty-three countries.

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

Summary for EPIVIR-HBV

International Patents:	56
US Patents:	1
Applicants:	1
NDAs:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	114
Clinical Trials:	28
Patent Applications:	2,199
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

Pharmacology for EPIVIR-HBV

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-HBV

Anti-HIV Agents

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

(-)-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

Epivir (TN)

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-HBV

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					Y
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	AB	RX	Yes	Yes

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Expired US Patents for EPIVIR-HBV

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

Paragraph IV (Patent) Challenges for EPIVIR-HBV

Drugname	Dosage	Strength	RLD	Date
	Tablets	100 mg

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International Patents for EPIVIR-HBV

Country	Document Number	Estimated Expiration
Yugoslavia	47799
Iceland	2515
Spain	2239802
Panama	8449301
Indonesia	29294
Japan	3264937

Supplementary Protection Certificates for EPIVIR-HBV

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0020	Belgium		PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
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
675032	Germany		PRODUCT NAME: LAMIVUDINE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH GEEIGNETEN SALZES; NAT. REGISTRATION NO/DATE: EU/1/96/015/001-002 19960808 FIRST REGISTRATION: CH 53662 53663 19960228
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
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