Trizivir Drug Patent Profile

When do Trizivir patents expire, and what generic alternatives are available?

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

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

Summary for Trizivir

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	20
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for Trizivir
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Trizivir
What excipients (inactive ingredients) are in Trizivir?	Trizivir excipients list
DailyMed Link:	Trizivir at DailyMed

See drug prices for Trizivir

Recent Clinical Trials for Trizivir

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3
AIDS Clinical Trials Group	Phase 3
Ines Perez	Phase 4

See all Trizivir clinical trials

Pharmacology for Trizivir

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 Trizivir

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

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 TRIZIVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRIZIVIR	Tablets	abacavir sulfate; lamivudine; zidovudine	300 mg/150 mg/ 300 mg	021205	1	2011-03-22

US Patents and Regulatory Information for Trizivir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000		DISCN	Yes	No

Expired US Patents for Trizivir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000
Viiv Hlthcare	TRIZIVIR	abacavir sulfate; lamivudine; zidovudine	TABLET;ORAL	021205-001	Nov 14, 2000

International Patents for Trizivir

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

Country	Patent Number	Title	Estimated Expiration
Portugal	93094	PROCESSO PARA A PREPARACAO DE 1,3-OXATIOLANOS SUBSTITUIDOS E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM
New Zealand	306419	Synergistic combinations of 1592U89, 3TC and optionally zidovudine or 1592U89, FTC and zidovudine
World Intellectual Property Organization (WIPO)	9852949
Japan	S63290895	ANTIVIRAL NUCLEOSIDE
Mexico	9707316	COMBINACIONES SINERGISTICAS DE ZIDOVUDINA, 1592U89 Y 3TC O FTC. (SYNERGISTIC COMBINATIONS OF ZIDOVUDINE, 1592U89 AND 3TC OR FTC.)
Hungary	201678	PROCESS FOR PRODUCING PHARMACEUTICAL COMPOSITIONS AGAINST HUMAN RETROVIRUS, COMPRISING 3'-AZIDO-3'-DEOXYTHYMIDE DERIVATIVES

Supplementary Protection Certificates for Trizivir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0434450	1999C0033	Belgium		PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
0817637	CA 2005 00028	Denmark
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
0817637	23/2005	Austria		PRODUCT NAME: KOMBINATION, UMFASSEND ABACAVIR BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES ESTERS ODER SOLVAT DAVON UND LAMIVUDIN BZW. EIN PHYSIOLOGISCH AKZEPTABLES SALZ, ESTER, SALZ DES; REGISTRATION NO/DATE: EU/1/04/298/001, EU/1/04/298/002 20041217
0382526	SZ 22/1996	Austria		PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE