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Last Updated: August 8, 2020

DrugPatentWatch Database Preview

Mitomycin - Generic Drug Details

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What are the generic drug sources for mitomycin and what is the scope of freedom to operate?

Mitomycin is the generic ingredient in five branded drugs marketed by Mobius Therap, Accord Hlthcare, Hospira, Mylan Labs Ltd, 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

SponsorPhase
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 3
The First Affiliated Hospital of Nanchang UniversityPhase 3
ZhuHai HospitalPhase 3

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
Mylan Labs Ltd MITOMYCIN mitomycin INJECTABLE;INJECTION 203386-001 Oct 13, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int MITOMYCIN mitomycin INJECTABLE;INJECTION 064117-002 Apr 19, 1995 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd MITOMYCIN mitomycin INJECTABLE;INJECTION 202670-001 Oct 13, 2017 AP RX 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
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes   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
>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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