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EPZICOM Drug Profile

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Which patents cover Epzicom, and what generic alternatives are available?

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. Ten 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:	1
Bulk Api Vendors:	17
Clinical Trials:	21
Patent Applications:	1,872
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EPZICOM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPZICOM
What excipients (inactive ingredients) are in EPZICOM?	EPZICOM excipients list
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

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

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

International Patents for EPZICOM

Country	Patent Number	Estimated Expiration
Slovenia	9110782
Japan	H01316375
Ireland	900452
Finland	894545
Germany	68924549

Supplementary Protection Certificates for EPZICOM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	SPC/GB05/027	United Kingdom		SPC/GB05/027: 20050922, EXPIRES: 20191216
0817637	288	Finland
0817637	CA 2005 00028	Denmark
0817637	C300195	Netherlands		PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDB AAR ZUURADDITIEZOUT, IN HET BIJZONDER HET HEMISULFAAT, EN LAMIV UDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT; REGISTRTION NO/DATE: EU/04/298/001-002 20041217
0434450	1999C0033	Belgium		PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628