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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Boehringer Ingelheim
Covington
Argus Health
Federal Trade Commission
Express Scripts
Daiichi Sankyo
Mallinckrodt
Cantor Fitzgerald

Generated: July 19, 2018

DrugPatentWatch Database Preview

Epivir Drug Profile

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When do Epivir patents expire, 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.

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

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.
Drug patent expirations by year for Epivir
Medical Subject Heading (MeSH) Categories for Epivir
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-001 Nov 17, 1995 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Viiv Hlthcare EPIVIR lamivudine TABLET;ORAL 020564-003 Jun 24, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Paragraph IV (Patent) Challenges for EPIVIR
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 100 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Tablets 150 mg and 300 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Oral Solution 10 mg/mL ➤ Subscribe ➤ Sign Up

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Supplementary Protection Certificates for Epivir

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

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
Federal Trade Commission
US Army
Chubb
McKesson
Harvard Business School
Accenture
Boehringer Ingelheim

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