ZIAGEN Drug Patent Profile

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

Ziagen is a drug marketed by Viiv Hlthcare and is included in two NDAs.

The generic ingredient in ZIAGEN is abacavir sulfate. 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 profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ziagen

A generic version of ZIAGEN was approved as abacavir sulfate by MYLAN PHARMS INC on June 18^th, 2012.

Summary for ZIAGEN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	15
Patent Applications:	5,052
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZIAGEN
What excipients (inactive ingredients) are in ZIAGEN?	ZIAGEN excipients list
DailyMed Link:	ZIAGEN at DailyMed

See drug prices for ZIAGEN

Recent Clinical Trials for ZIAGEN

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

Sponsor	Phase
Cellceutix Corporation	Phase 1
Bayside Health	Phase 4
AIDS Clinical Trials Group	Phase 3

See all ZIAGEN clinical trials

Pharmacology for ZIAGEN

Drug Class	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 ZIAGEN

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 ZIAGEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZIAGEN	Oral Solution	abacavir sulfate	20 mg/mL	020978	1	2012-12-27
ZIAGEN	Tablets	abacavir sulfate	300 mg	020977	1	2009-01-28

US Patents and Regulatory Information for ZIAGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998	AA	RX	Yes	Yes
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998		DISCN	Yes	No

Expired US Patents for ZIAGEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998
Viiv Hlthcare	ZIAGEN	abacavir sulfate	SOLUTION;ORAL	020978-001	Dec 17, 1998
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998
Viiv Hlthcare	ZIAGEN	abacavir sulfate	TABLET;ORAL	020977-001	Dec 17, 1998

International Patents for ZIAGEN

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

Country	Patent Number	Title	Estimated Expiration
Iceland	5246
Turkey	200002293
Estonia	03924	Karbotsükliline nukleosiidhemisulfaat ja selle kasutamine viirusinfektsioonide raviks
Canada	1340589	NUCLEOSIDES THERAPEUTIQUES (THEREPEUTIC NUCLEOSIDES)
Argentina	012702	COMBINACION DE (-)-(1S,4R)-4-[2-AMINO-6-(CICLOPROPILAMINO)-9H-PURIN-9-IL]- 2-CICLOPENTENO-1-METANOL Y UN INHIBIDOR DEE TRANSCRIPTASA REVERSA NO NUCLEOSIDOUNA FORMULACION FARMACEUTICA QUE COMPRENDE LA COMBINACION, SU USO MEDICO EN TERAPIA PARA TRATAR LA INFECCION DE VIH, Y UN EMPAQUE PARA EL PACIENTE
Denmark	315689

Supplementary Protection Certificates for ZIAGEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	C00817637/01	Switzerland		PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
0817637	05C0022	France		PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
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	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
0434450	33/1999	Austria		PRODUCT NAME: ''ABACAVIR'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER DERIVATS, EINSCHLIESSLICH ABACAVIR-SULFAT.; NAT. REGISTRATION NO/DATE: EU/1/99/112/001 EU/1/99/112/002 19990708; FIRST REGISTRATION: LI 55048 001, 55049 002 19990628
0434450	1999C0033	Belgium		PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628