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AstraZeneca
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Last Updated: February 26, 2024

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, 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
Columbia UniversityN/A
VarianN/A

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
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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
Hikma MITOMYCIN mitomycin INJECTABLE;INJECTION 064117-003 Jun 2, 1999 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd MITOMYCIN mitomycin INJECTABLE;INJECTION 215687-001 Oct 20, 2021 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma MITOMYCIN mitomycin INJECTABLE;INJECTION 216732-003 Oct 30, 2023 AP RX No 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
World Intellectual Property Organization (WIPO) 2013011504 ⤷  Try a Trial
Japan 5670546 ⤷  Try a Trial
Japan 5448071 ⤷  Try a Trial
Denmark 2525777 ⤷  Try a Trial
Japan 2014097399 APPARATUS AND METHOD FOR RECONSTITUTING PHARMACEUTICAL AND PREPARING RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Colorcon
McKesson
AstraZeneca
Harvard Business School

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