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Last Updated: July 6, 2020

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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. Eight 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

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SponsorPhase
Augusta UniversityPhase 4
Infectious Diseases Institute, UgandaPhase 3
Médecins Sans Frontières, BelgiumPhase 4

See all zidovudine clinical trials

Generic filers with tentative approvals for ZIDOVUDINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MGCAPSULE; 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
Cipla ZIDOVUDINE zidovudine TABLET;ORAL 090561-001 Oct 27, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine INJECTABLE;INJECTION 019951-001 Feb 2, 1990 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine SYRUP;ORAL 019910-001 Sep 28, 1989 AA RX Yes Yes   Start Trial   Start Trial   Start Trial
Hec Pharm ZIDOVUDINE zidovudine TABLET;ORAL 202058-001 Oct 7, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine TABLET;ORAL 020518-001 Dec 19, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine TABLET;ORAL 020518-002 Oct 4, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Am Regent ZIDOVUDINE zidovudine INJECTABLE;INJECTION 091457-001 May 6, 2010 DISCN No No   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 zidovudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare RETROVIR zidovudine TABLET;ORAL 020518-002 Oct 4, 1996   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine TABLET;ORAL 020518-001 Dec 19, 1995   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine INJECTABLE;INJECTION 019951-001 Feb 2, 1990   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine CAPSULE;ORAL 019655-001 Mar 19, 1987   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine INJECTABLE;INJECTION 019951-001 Feb 2, 1990   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine INJECTABLE;INJECTION 019951-001 Feb 2, 1990   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine INJECTABLE;INJECTION 019951-001 Feb 2, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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