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EPIVIR-HBV Drug Profile

When do Epivir-hbv patents expire, 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.

The generic ingredient in EPIVIR-HBV 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-HBV

US Patents:	1
Applicants:	1
NDAs:	2
Suppliers / Packagers:	3
Bulk Api Vendors:	112
Clinical Trials:	29
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

Drug patent expirations by year for EPIVIR-HBV

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

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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	➤ Try a Free Trial	➤ Try a Free Trial			Y	➤ Try a Free Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	AB	RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free 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	➤ Try a Free Trial	➤ Try a Free Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	➤ Try a Free Trial	➤ Try a Free Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	➤ Try a Free Trial	➤ Try a Free Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998	➤ Try a Free Trial	➤ Try a Free Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	➤ Try a Free Trial	➤ Try a Free Trial
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Paragraph IV (Patent) Challenges for EPIVIR-HBV

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Tablets	100 mg	➤ Subscribe	➤ Try a Free Trial

International Patents for EPIVIR-HBV

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Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9842321	➤ Try a Free Trial
United Kingdom	9706295	➤ Try a Free Trial
Israel	138098	➤ Try a Free Trial
China	1255849	➤ Try a Free Trial
Spain	2239802	➤ Try a Free Trial
El Salvador	1998000040	➤ Try a Free Trial
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for EPIVIR-HBV

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB98/019	United Kingdom	➤ Try a Free Trial	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
C/GB96/043	United Kingdom	➤ Try a Free Trial	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
C0020	Belgium	➤ Try a Free Trial	PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
80018	Netherlands	➤ Try a Free Trial	PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
C0035	Belgium	➤ Try a Free Trial	PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228
675032	Germany	➤ Try a Free Trial	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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Summary for EPIVIR-HBV

Pharmacology for EPIVIR-HBV

Medical Subject Heading (MeSH) Categories for EPIVIR-HBV

Synonyms for EPIVIR-HBV

Paragraph IV (Patent) Challenges for EPIVIR-HBV

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