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Last Updated: March 29, 2024

Mitomycin - Generic Drug Details


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What are the generic drug 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, 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

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

SponsorPhase
City of Hope Medical CenterPhase 2
VarianN/A
Columbia UniversityN/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
Gland Pharma Ltd MITOMYCIN mitomycin INJECTABLE;INJECTION 216648-001 Nov 22, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Urogen Pharma JELMYTO mitomycin POWDER;PYELOCALYCEAL 211728-001 Apr 15, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Hikma MITOMYCIN mitomycin INJECTABLE;INJECTION 064117-003 Jun 2, 1999 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Supergen MITOZYTREX mitomycin INJECTABLE;INJECTION 050763-001 Nov 14, 2002 DISCN Yes No ⤷  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
European Patent Office 2734187 MATÉRIAUX ET MÉTHODE DE TRAITEMENT DE CAVITÉS CORPORELLES INTERNES (MATERIALS AND METHOD FOR TREATING INTERNAL BODY CAVITIES) ⤷  Try a Trial
Japan 5448071 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013011504 ⤷  Try a Trial
Japan 2009543608 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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