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Last Updated: March 28, 2024

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, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Rk Pharma, Supergen, Bristol, Bristol Myers, and Urogen Pharma, and is included in sixteen 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. Twelve 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
City of Hope Medical CenterPhase 2
Columbia UniversityN/A
VarianN/A

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Pharmacology for mitomycin
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for MITOMYCIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JELMYTO Powder for Injection mitomycin 40 mg/vial 211728 1 2023-12-28

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
Bristol Myers MUTAMYCIN mitomycin INJECTABLE;INJECTION 062336-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rk Pharma MITOMYCIN mitomycin INJECTABLE;INJECTION 203386-001 Oct 13, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol MUTAMYCIN mitomycin INJECTABLE;INJECTION 050450-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira MITOMYCIN mitomycin INJECTABLE;INJECTION 064106-001 Nov 29, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal MITOMYCIN mitomycin INJECTABLE;INJECTION 214504-001 Sep 6, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare MITOMYCIN mitomycin INJECTABLE;INJECTION 064144-001 Apr 30, 1998 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Denmark 2525777 ⤷  Try a Trial
European Patent Office 2734187 MATÉRIAUX ET MÉTHODE DE TRAITEMENT DE CAVITÉS CORPORELLES INTERNES (MATERIALS AND METHOD FOR TREATING INTERNAL BODY CAVITIES) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013011504 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2011089604 ⤷  Try a Trial
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) ⤷  Try a Trial
European Patent Office 2046653 DISPOSITIF ET PROCÉDÉ DE RECONSTITUTION D'UN PRODUIT PHARMACEUTIQUE ET PRÉPARATION DU PRODUIT PHARMACEUTIQUE EN VUE D'UNE APPLICATION TRANSITOIRE (APPARATUS AND METHOD FOR RECONSTITUTING A PHARMACEUTICAL AND PREPARING THE RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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