EPZICOM Drug Patent Profile

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. Eight suppliers are listed for this compound. Additional details are available on the abacavir sulfate; lamivudine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Epzicom

A generic version of EPZICOM was approved as abacavir sulfate; lamivudine by TEVA PHARMS USA on September 29^th, 2016.

Summary for EPZICOM

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	21
Patent Applications:	2,031
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	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 1A1 Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EPZICOM

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for EPZICOM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EPZICOM	Tablets	abacavir sulfate; lamivudine	600 mg/300 mg	021652	1	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

International Patents for EPZICOM

See the table below for patents covering EPZICOM around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0479822	NUCLEOSIDES THERAPEUTIQUES (THERAPEUTIC NUCLEOSIDES)
Australia	7771991
Canada	2289655
Russian Federation	2092485	1,3-OXATHIOLANE, GEOMETRICAL AND OPTICAL ISOMERS THEREOF, MIXTURES OF SAID ISOMERS, METHODS OF PREPARATION THEREOF, AND PHARMACEUTICAL COMPOSITION HAVING ANTIVIRAL ACTIVITY

Supplementary Protection Certificates for EPZICOM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	SPC016/2005	Ireland		SPC016/2005: 20060407, EXPIRES: 20191216
0817637	C00817637/01	Switzerland		PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
0817637	SPC/GB05/027	United Kingdom		SPC/GB05/027: 20050922, EXPIRES: 20191216
0382526	SPC/GB96/043	United Kingdom		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