Mitomycin - Generic Drug Details

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, 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

International Patents:	18
US Patents:	7
Tradenames:	5
Applicants:	12
NDAs:	16
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	239
Patent Applications:	3,246
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

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
Rk Pharma	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	202670-002	Oct 13, 2017	AP	RX	No	No
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes			Y
Eugia Pharma	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	216732-003	Oct 30, 2023	AP	RX	No	No
Gland Pharma Ltd	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	215687-002	Oct 20, 2021	AP	RX	No	No
Accord Hlthcare	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064144-003	Aug 11, 2009	AP	RX	No	Yes
Accord Hlthcare	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064144-001	Apr 30, 1998	AP	RX	No	Yes

International Patents for mitomycin

Country	Patent Number	Title	Estimated Expiration
Japan	5448071
World Intellectual Property Organization (WIPO)	2008008802
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)
Denmark	2525777
Israel	221040	חומר ושיטה לטיפול בחללי גוף פנימיים (Material and method for treating internal cavities)
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)