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Last Updated: May 14, 2021

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ZIDOVUDINE - Generic Drug Details

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What are the generic sources for zidovudine and what is the scope of patent protection?

Zidovudine is the generic ingredient in two branded drugs marketed by Viiv Hlthcare, Aurobindo Pharma Ltd, Cipla Ltd, Am Regent, Liaoning Chengda, Aurobindo, Aurobindo Pharma, Cipla, Hec Pharm, Hetero Labs Ltd Iii, Hikma, Mylan Labs Ltd, Mylan Pharms Inc, and Ranbaxy Labs Ltd, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for zidovudine. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for ZIDOVUDINE

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Recent Clinical Trials for ZIDOVUDINE

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

SponsorPhase
Augusta UniversityPhase 4
University of Cape TownPhase 4
Infectious Diseases Institute, UgandaPhase 3

See all ZIDOVUDINE clinical trials

Generic filers with tentative approvals for ZIDOVUDINE
Applicant Application No. Strength Dosage Form
  Get Started for $10  Get Started for $10100MGCAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for ZIDOVUDINE

US Patents and Regulatory Information for ZIDOVUDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ranbaxy Labs Ltd ZIDOVUDINE zidovudine TABLET;ORAL 077327-001 Sep 19, 2005 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Viiv Hlthcare RETROVIR zidovudine SOLUTION;ORAL 019910-001 Sep 28, 1989 AA RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Aurobindo Pharma ZIDOVUDINE zidovudine TABLET;ORAL 022294-001 Jul 23, 2009 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
Viiv Hlthcare RETROVIR zidovudine TABLET;ORAL 020518-002 Oct 4, 1996 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Mylan Labs Ltd ZIDOVUDINE zidovudine TABLET;ORAL 200732-001 Feb 23, 2011 DISCN No No   Get Started for $10   Get Started for $10   Get Started for $10
>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 ZIDOVUDINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare RETROVIR zidovudine INJECTABLE;INJECTION 019951-001 Feb 2, 1990   Get Started for $10   Get Started for $10
Viiv Hlthcare RETROVIR zidovudine CAPSULE;ORAL 019655-001 Mar 19, 1987   Get Started for $10   Get Started for $10
Viiv Hlthcare RETROVIR zidovudine TABLET;ORAL 020518-002 Oct 4, 1996   Get Started for $10   Get Started for $10
Viiv Hlthcare RETROVIR zidovudine CAPSULE;ORAL 019655-001 Mar 19, 1987   Get Started for $10   Get Started for $10
Viiv Hlthcare RETROVIR zidovudine INJECTABLE;INJECTION 019951-001 Feb 2, 1990   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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