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Last Updated: July 10, 2020

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MITOSOL Drug Profile


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

Mitosol is a drug marketed by Mobius Therap and is included in one NDA. There are five patents protecting this drug.

This drug has nine patent family members in five countries.

The generic ingredient in MITOSOL 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 Mitosol

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

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

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

See all MITOSOL clinical trials

US Patents and Regulatory Information for MITOSOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes   Start Trial   Start Trial Y   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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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Express Scripts
Harvard Business School
Moodys
Dow

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