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Last Updated: November 26, 2022

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, Gland Pharma Ltd, Hikma, Hong Kong, Hospira, Rk Pharma, Supergen, Bristol, Bristol Myers, and Urogen Pharma, and is included in fourteen 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. Eight suppliers are listed for this compound.

Summary for mitomycin
Drug Prices for mitomycin

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Recent Clinical Trials for mitomycin

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SponsorPhase
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
University of BernPhase 2
Hospital Centre Biel/BiennePhase 2

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Pharmacology for mitomycin
Drug Class Alkylating 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
Hong Kong MITOMYCIN mitomycin INJECTABLE;INJECTION 214505-002 Sep 8, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare MITOMYCIN mitomycin INJECTABLE;INJECTION 064144-001 Apr 30, 1998 AP RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers MUTAMYCIN mitomycin INJECTABLE;INJECTION 062336-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bristol MUTAMYCIN mitomycin INJECTABLE;INJECTION 050450-001 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hong Kong MITOMYCIN mitomycin INJECTABLE;INJECTION 214505-001 Sep 8, 2022 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for mitomycin

Country Patent Number Title Estimated Expiration
Canada 2659314 DISPOSITIF ET PROCEDE DE RECONSTITUTION D'UN PRODUIT PHARMACEUTIQUE ET PREPARATION DU PRODUIT PHARMACEUTIQUE EN VUE D'UNE APPLICATION TRANSITOIRE (APPARATUS AND METHOD FOR RECONSTITUTING A PHARMACEUTICAL ANDPREPARING THE RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION) See Plans and Pricing
Japan 2014097399 APPARATUS AND METHOD FOR RECONSTITUTING PHARMACEUTICAL AND PREPARING RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION See Plans and Pricing
Japan 5448071 See Plans and Pricing
European Patent Office 3175843 APPAREIL ET PROCÉDÉ POUR RECONSTITUER UN PRODUIT PHARMACEUTIQUE ET PRÉPARER LE PRODUIT PHARMACEUTIQUE RECONSTITUÉ POUR UNE APPLICATION TRANSITOIRE (APPARATUS AND METHOD FOR RECONSTITUTING A PHARMACEUTICAL AND PREPARING THE RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION) See Plans and Pricing
Australia 2007272514 Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013011504 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Harvard Business School

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