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Last Updated: March 28, 2024

Ziagen Drug Patent Profile


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When do Ziagen patents expire, and when can generic versions of Ziagen launch?

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 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

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

SponsorPhase
Cellceutix CorporationPhase 1
Bayside HealthPhase 4
AIDS Clinical Trials GroupPhase 3

See all Ziagen clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate TABLET;ORAL 020977-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare ZIAGEN abacavir sulfate SOLUTION;ORAL 020978-001 Dec 17, 1998 ⤷  Try a Trial ⤷  Try a Trial
>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.

Country Patent Number Title Estimated Expiration
Denmark 0434450 ⤷  Try a Trial
Japan 2875814 ⤷  Try a Trial
African Regional IP Organization (ARIPO) 2009 Carbocylic nucleoside hemisulfate and its use in treating viral infections. ⤷  Try a Trial
Slovenia 0983271 ⤷  Try a Trial
Slovakia 156199 HEMISULFATE SALT OF (1S,4R)-CIS-4-[2-AMINO-6-(CYCLOPROPYLAMINO)- 9H-PURIN-9-YL]-2-CYCLOPENTENE-1-METHANOL, PROCESS FOR ITS PREPARATION, PHARMACEUTICAL COMPOSITION CONTAINING THE SAME AND ITS USE ⤷  Try a Trial
Israel 137403 PHARMACEUTICAL COMPOSITIONS COMPRISING (1S,4R) - CIS - 4 - [2 - AMINO - 6 - (CYCLOPROPYLAMINO) - 9H - PURIN - 9 - YL] - 2 - CYCLOPENTENE - 1 - METHANOL ⤷  Try a Trial
Germany 69906934 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for Ziagen

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0817637 C300195 Netherlands ⤷  Try a Trial 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
0434450 33/1999 Austria ⤷  Try a Trial 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 C990028 Netherlands ⤷  Try a 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 ⤷  Try a 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
0817637 23/2005 Austria ⤷  Try a Trial 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
0817637 C00817637/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ABACAVIR + LAMIVUDIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 56977 31.10.2005
0434450 1999C0033 Belgium ⤷  Try a Trial PRODUCT NAME: ABACAVIR SULFATE; NATL. REGISTRATION NO/DATE: EU/1/99/112/001 19990708; FIRST REGISTRATION: CH 55048 19990628
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.