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EPZICOM Drug Profile

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

Epzicom is a drug marketed by Viiv Hlthcare and is included in one NDA.

The generic ingredient in EPZICOM is abacavir sulfate; lamivudine. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

Summary for EPZICOM

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	16
Clinical Trials:	21
Patent Applications:	1,824
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EPZICOM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPZICOM
DailyMed Link:	EPZICOM at DailyMed

See drug prices for EPZICOM

Recent Clinical Trials for EPZICOM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 3
AIDS Clinical Trials Group	Phase 3
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3

See all EPZICOM clinical trials

Recent Litigation for EPZICOM

Identify potential future generic entrants

District Court Litigation

Case Name	Date
ViiV Healthcare UK Ltd. v. Lupin Ltd.	2011-06-29
Glaxo Group Ltd. v. Lupin Ltd.	2008-08-29

See all EPZICOM litigation

PTAB Litigation

Petitioner	Date
Teva Pharmaceuticals USA, Inc.	2015-01-08
Apotex Corp.	2014-06-02

See all EPZICOM litigation

Pharmacology for EPZICOM

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Synonyms for EPZICOM

((1R,4S)-4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)cyclopent-2-enyl)methanol

(1R-cis)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol

(1R,4S)-4-[2-Amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol

(1R,4S)-Abacavir

(1R)-4beta-[2-Amino-6-(cyclopropylamino)-9H-purine-9-yl]-2-cyclopentene-1beta-methanol

[(1R,4S)-4-[2-amino-6-(cyclopropylamino)purin-9-yl]cyclopent-2-en-1-yl]methanol

136470-79-6

2-Cyclopentene-1-methanol, 4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)-, (1R-cis)-

2-Cyclopentene-1-methanol, 4-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)-, (1R,4S)-

2-Cyclopentene-1-methanol, 4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-, (1R-cis)-

Abacavir sulfate impurity A [WHO-IP]

AC1LAJJF

AKOS015894952

CTK0G9914

DTXSID20332855

ent-Abacavir

FT-0660944

I14-32396

NCGC00241110-01

SCHEMBL52190

UNII-X9A7099R51

X9A7099R51

ZINC4400

Paragraph IV (Patent) Challenges for EPZICOM

Tradename	Dosage	Ingredient	NDA	Submissiondate
EPZICOM	TABLET;ORAL	abacavir sulfate; lamivudine	021652	2007-09-27

US Patents and Regulatory Information for EPZICOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004	AB	RX	Yes	Yes

Expired US Patents for EPZICOM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004
Viiv Hlthcare	EPZICOM	abacavir sulfate; lamivudine	TABLET;ORAL	021652-001	Aug 2, 2004