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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. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ninety-one patent family members in forty-eight countries.

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

Summary for EPZICOM

International Patents:	91
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	5
Bulk Api Vendors:	14
Clinical Trials:	21
Patent Applications:	1,673
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

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

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

(+/-)-Abacavir

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

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

[(1S,4R)-4-[2-amino-6-(cyclopropylamino)-9-purinyl]-1-cyclopent-2-enyl]methanol

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

[(1s,4r)-4-[2-amino-6-(cyclopropylamino)purin-9-yl]-1-cyclopent-2-enyl]methanol

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

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

{(1S-cis)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]cyclopent-2-en-1-yl}methanol

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

136470-78-5

136470-78-5 (Succinate)

1592U89

188062-50-2

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

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

470A785

A807079

AB01566826_01

abacavir

Abacavir (INN)

Abacavir [INN:BAN]

Abacavir [INN]

Abacavir sulfate

AC-1299

AC1L9AXG

ACT03218

AK163479

AKOS024464970

AM015240

BC214924

BDBM50366816

Bio-0001

C-18039

C07624

CC-23613

CHEBI:421707

CHEMBL1380

CJ-31308

CS-1354

D07057

D0A4IJ

DB01048

DR001043

EN300-258000

Epitope ID:137341

FT-0631153

HE058172

HY-17423

J-700136

KS-00000XJM

MCGSCOLBFJQGHM-SCZZXKLOSA-N

MFCD00903850

MLS006010117

MolPort-006-069-118

NCGC00164560-01

NCGC00164560-02

NSC742406

NU000340

SC-16996

SC-20023

SCHEMBL38632

SMR004701251

ST24045890

UNII-WR2TIP26VS

W-5205

WR2TIP26VS

Ziagen

Ziagen (TM)(*Succinate salt*)

Ziagen (TN)

ZINC2015928

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					Y

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

Paragraph IV (Patent) Challenges for EPZICOM

Drugname	Dosage	Strength	RLD	Date
	Tablets	600 mg/300 mg

International Patents for EPZICOM

Country	Patent Number	Estimated Expiration
Japan	2000514096
Colombia	4950569
Hong Kong	1024236

Supplementary Protection Certificates for EPZICOM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0434450	990028	Netherlands		PRODUCT NAME: ABACAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER, IN HET BIJZONDER ABACAVIR SULFAAT; REGISTRATION NO/DATE: EU/1/99/112/001-002 19990708
0434450	SPC/GB99/032	United Kingdom		PRODUCT NAME: ABACAVIR, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR DERIVATIVE INCLUDING ABACAVIR SULPHATE; REGISTERED: CH CH 55048 001 19990628; CH CH 55049 002 19990628; UK EU/1/99/112/001 19990708; UK EU/1/99/112/002 19990708
0817637	C00817637/01	Switzerland		PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005