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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. 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-eight 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

International Patents:	56
US Patents:	1
Applicants:	2
NDAs:	4
Suppliers / Packagers:	6
Bulk Api Vendors:	114
Clinical Trials:	28
Patent Applications:	2,165
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPIVIR
DailyMed Link:	EPIVIR at DailyMed

Drug patent expirations by year for EPIVIR

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

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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
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	AA	RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial			Y	➤ Try a Free Trial
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
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	AB	RX	Yes	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	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

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Expired US Patents for EPIVIR

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

Drugname	Dosage	Strength	RLD	Submissiondate
➤ Subscribe	Tablets	100 mg	➤ Subscribe	2007-10-31
➤ Subscribe	Tablets	150 mg and 300 mg	➤ Subscribe	2007-10-16
➤ Subscribe	Oral Solution	10 mg/mL	➤ Subscribe	2011-11-22

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International Patents for EPIVIR

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Country	Document Number	Estimated Expiration
Bulgaria	64690	➤ Try a Free Trial
United Kingdom	9706295	➤ Try a Free Trial
Czech Republic	298008	➤ Try a Free Trial
China	1255849	➤ Try a Free Trial
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for EPIVIR

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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
C0020	Belgium	➤ Try a Free Trial	PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Summary for EPIVIR

Pharmacology for EPIVIR

Medical Subject Heading (MeSH) Categories for EPIVIR

Synonyms for EPIVIR

Paragraph IV (Patent) Challenges for EPIVIR

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