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, Gland Pharma Ltd, Hikma, Hong Kong, Hospira, Rk Pharma, Supergen, Bristol, Bristol Myers, and Urogen Pharma, and is included in fourteen 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. Eight suppliers are listed for this compound.

Summary for mitomycin

International Patents:	18
US Patents:	7
Tradenames:	5
Applicants:	11
NDAs:	14
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	235
Patent Applications:	7,386
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
First Affiliated Hospital Xi'an Jiaotong University	N/A
University of Bern	Phase 2
Hospital Centre Biel/Bienne	Phase 2

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

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
Hong Kong	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	214505-002	Sep 8, 2022	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
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
Bristol Myers	MUTAMYCIN	mitomycin	INJECTABLE;INJECTION	062336-001	Approved Prior to Jan 1, 1982		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Mobius Therap	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572-001	Feb 7, 2012		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Bristol	MUTAMYCIN	mitomycin	INJECTABLE;INJECTION	050450-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Hong Kong	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	214505-001	Sep 8, 2022	AP	RX	No	No	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

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Country	Patent Number	Title	Estimated Expiration
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)	See Plans and Pricing
Japan	2014097399	APPARATUS AND METHOD FOR RECONSTITUTING PHARMACEUTICAL AND PREPARING RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION	See Plans and Pricing
Japan	5448071		See Plans and Pricing
European Patent Office	3175843	APPAREIL ET PROCÉDÉ POUR RECONSTITUER UN PRODUIT PHARMACEUTIQUE ET PRÉPARER LE PRODUIT PHARMACEUTIQUE RECONSTITUÉ POUR UNE APPLICATION TRANSITOIRE (APPARATUS AND METHOD FOR RECONSTITUTING A PHARMACEUTICAL AND PREPARING THE RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION)	See Plans and Pricing
Australia	2007272514	Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application	See Plans and Pricing
World Intellectual Property Organization (WIPO)	2013011504		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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