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Last Updated: September 26, 2022

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, Gland Pharma Ltd, Hikma, Hospira, Rk Pharma, Supergen, Bristol, Bristol Myers, and Urogen Pharma, and is included in twelve 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. Seven 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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University of BernPhase 2
Hospital Centre Biel/BiennePhase 2
University Hospital Inselspital, BernePhase 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
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
Rk Pharma MITOMYCIN mitomycin INJECTABLE;INJECTION 202670-001 Oct 13, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hikma MITOMYCIN mitomycin INJECTABLE;INJECTION 064180-001 Dec 23, 1999 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Urogen Pharma JELMYTO mitomycin POWDER;PYELOCALYCEAL 211728-001 Apr 15, 2020 RX Yes Yes 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
World Intellectual Property Organization (WIPO) 2013011504 See Plans and Pricing
Japan 5670546 See Plans and Pricing
Germany 212011100034 See Plans and Pricing
Israel 230530 חומרים ושיטה לטיפול בחללים של הגוף (Materials and method for treating internal body cavities) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.