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Last Updated: July 12, 2020

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ZIAGEN Drug 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.

US ANDA Litigation and Generic Entry Outlook for Ziagen

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

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Drug patent expirations by year for ZIAGEN
Drug Prices for ZIAGEN

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Recent Clinical Trials for ZIAGEN

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SponsorPhase
Cellceutix CorporationPhase 1
ViiV HealthcareN/A
GlaxoSmithKlineN/A

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Paragraph IV (Patent) Challenges for ZIAGEN
Tradename Dosage Ingredient NDA Submissiondate
ZIAGEN SOLUTION;ORAL abacavir sulfate 020978 2012-12-27
ZIAGEN TABLET;ORAL abacavir sulfate 020977 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   Start Trial   Start Trial   Start Trial
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>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

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

Supplementary Protection Certificates for ZIAGEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0434450 C990028 Netherlands   Start Trial 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 990028 Netherlands   Start Trial 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   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Harvard Business School
Mallinckrodt
Colorcon
Medtronic
Boehringer Ingelheim

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