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Last Updated: February 28, 2021

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Mitomycin - Generic Drug Details

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What are the generic sources for mitomycin and what is the scope of patent protection?

Mitomycin is the generic ingredient in five branded drugs marketed by Mobius Therap, Accord Hlthcare, Hospira, Rk Pharma, West-ward Pharms Int, Supergen, Bristol, Bristol Myers, and Urogen Pharma, and is included in eleven NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mitomycin has eighteen patent family members in nine countries.

There are seven drug master file entries for mitomycin. Six suppliers are listed for this compound.

Drug Prices for mitomycin

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Recent Clinical Trials for mitomycin

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

Kaplan Medical CenterPhase 2
Michele ReniPhase 2
Asmaa Ahmed Ali YoussifEarly Phase 1

See all mitomycin clinical trials

Pharmacology for mitomycin
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

US Patents and Regulatory Information for mitomycin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int MITOMYCIN mitomycin INJECTABLE;INJECTION 064117-001 Apr 19, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare MITOMYCIN mitomycin INJECTABLE;INJECTION 064144-001 Apr 30, 1998 AP RX No Yes   Start Trial   Start Trial   Start Trial
West-ward Pharms Int MITOMYCIN mitomycin INJECTABLE;INJECTION 064180-002 Dec 23, 1999 AP RX No No   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 Y   Start Trial
Rk Pharma MITOMYCIN mitomycin INJECTABLE;INJECTION 202670-001 Oct 13, 2017 AP RX 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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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.