ZIAGEN Drug Patent Profile

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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.

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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:	4,174
Drug Prices:	Drug price information for ZIAGEN
What excipients (inactive ingredients) are in ZIAGEN?	ZIAGEN excipients list
DailyMed Link:	ZIAGEN at DailyMed

Drug patent expirations by year 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

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

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Glossary

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

Expired US Patents for ZIAGEN

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

International Patents for ZIAGEN

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

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Country	Patent Number	Title	Estimated Expiration
New Zealand	500865	Hemisulfate salt of (1S,4R)-cis-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol for treating HIV or HBV	⤷ Sign Up
Australia	739953		⤷ Sign Up
Australia	7765598		⤷ Sign Up
Australia	636108		⤷ Sign Up
Ireland	990825		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ZIAGEN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0817637	05C0022	France	⤷ Sign Up	PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
0817637	C300195	Netherlands	⤷ Sign Up	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
0817637	23/2005	Austria	⤷ Sign Up	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	C990028	Netherlands	⤷ Sign Up	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	33/1999	Austria	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description