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Last Updated: March 3, 2024

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. Four 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
Michelle Abou-JaoudePhase 1
Inflammasome TherapeuticsPhase 1
Johns Hopkins UniversityPhase 1/Phase 2

See all zidovudine clinical trials

Generic filers with tentative approvals for ZIDOVUDINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a 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
Liaoning Chengda ZIDOVUDINE zidovudine INJECTABLE;INJECTION 204538-001 Nov 26, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo ZIDOVUDINE zidovudine TABLET;ORAL 077267-001 Sep 19, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd ZIDOVUDINE zidovudine CAPSULE;ORAL 078128-001 Mar 27, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hec Pharm ZIDOVUDINE zidovudine TABLET;ORAL 202058-001 Oct 7, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare RETROVIR zidovudine TABLET;ORAL 020518-001 Dec 19, 1995 DISCN No 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 zidovudine

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

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