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Last Updated: July 6, 2020

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RETROVIR Drug Profile


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Which patents cover Retrovir, and what generic alternatives are available?

Retrovir is a drug marketed by Viiv Hlthcare and is included in four NDAs.

The generic ingredient in RETROVIR is zidovudine. There are twenty-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the zidovudine profile page.

US ANDA Litigation and Generic Entry Outlook for Retrovir

A generic version of RETROVIR was approved as zidovudine by AUROBINDO on September 19th, 2005.

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Drug patent expirations by year for RETROVIR
Drug Prices for RETROVIR

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Recent Clinical Trials for RETROVIR

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SponsorPhase
Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranPhase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)N/A
Aarhus University HospitalPhase 4

See all RETROVIR clinical trials

US Patents and Regulatory Information for RETROVIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare RETROVIR zidovudine CAPSULE;ORAL 019655-001 Mar 19, 1987 AB RX Yes Yes   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 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
Viiv Hlthcare RETROVIR zidovudine TABLET;ORAL 020518-002 Oct 4, 1996 DISCN Yes 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 RETROVIR

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for RETROVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513917 SPC/GB98/019 United Kingdom   Start Trial PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318
0513917 98C0020 Belgium   Start Trial PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
0513917 C980018 Netherlands   Start Trial PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Dow
Colorcon
Moodys
Johnson and Johnson

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