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Last Updated: June 3, 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, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Rk Pharma, Supergen, Bristol, Bristol Myers, and Urogen Pharma, and is included in seventeen 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

International Patents:	18
US Patents:	7
Tradenames:	5
Applicants:	13
NDAs:	17
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	240
Patent Applications:	5,142
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for mitomycin
What excipients (inactive ingredients) are in mitomycin?	mitomycin excipients list
DailyMed Link:	mitomycin at DailyMed

See drug prices for mitomycin

Recent Clinical Trials for mitomycin

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

Sponsor	Phase
City of Hope Medical Center	Phase 2
Columbia University	N/A
Varian	N/A

See all mitomycin clinical trials

Pharmacology for mitomycin

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for mitomycin

Alkylating Agents
Antibiotics, Antineoplastic
Cross-Linking Reagents
Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for mitomycin

L01DC	Other cytotoxic antibiotics
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	211269-002	Apr 5, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mobius Therap	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572-001	Feb 7, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2011089604		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008008802		⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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