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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 eleven 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

International Patents:	91
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	6
Bulk Api Vendors:	55
Clinical Trials:	21
Patent Applications:	3,971
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPZICOM
DailyMed Link:	EPZICOM at DailyMed

Generic Entry Opportunity Date for EPZICOM

NDA:

021652

Dosage::

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for EPZICOM

Ingredient-type	Nucleoside Analog
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

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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

Paragraph IV (Patent) Challenges for EPZICOM

Drugname	Dosage	Strength	RLD	Date
	Tablets	600 mg/300 mg

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International Patents for EPZICOM

Country	Document Number	Estimated Expiration
Croatia	P980265
Argentina	012702
Egypt	23836
Estonia	9900537

Supplementary Protection Certificates for EPZICOM

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90028	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
0817637/01	Switzerland		PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
0028	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
00195	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