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Last Updated: September 27, 2020

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MUTAMYCIN Drug Profile

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

Mutamycin is a drug marketed by Bristol and Bristol Myers and is included in two NDAs.

The generic ingredient in MUTAMYCIN is mitomycin. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the mitomycin profile page.

US ANDA Litigation and Generic Entry Outlook for Mutamycin

A generic version of MUTAMYCIN was approved as mitomycin by WEST-WARD PHARMS INT on April 19th, 1995.

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Summary for MUTAMYCIN
Drug patent expirations by year for MUTAMYCIN
Recent Clinical Trials for MUTAMYCIN

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

SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 2
National Cancer Institute (NCI)Phase 3
Mayo ClinicPhase 2

See all MUTAMYCIN clinical trials

US Patents and Regulatory Information for MUTAMYCIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol MUTAMYCIN mitomycin INJECTABLE;INJECTION 050450-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers MUTAMYCIN mitomycin INJECTABLE;INJECTION 062336-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol MUTAMYCIN mitomycin INJECTABLE;INJECTION 050450-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers MUTAMYCIN mitomycin INJECTABLE;INJECTION 062336-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers MUTAMYCIN mitomycin INJECTABLE;INJECTION 062336-003 Mar 10, 1988 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

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