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, 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:	7,361
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
Varian	N/A
Columbia University	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	211269-003	Apr 5, 2024	AP	RX	No	No
Gland Pharma Ltd	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	215687-002	Oct 20, 2021	AP	RX	No	No
Bristol Myers	MUTAMYCIN	mitomycin	INJECTABLE;INJECTION	062336-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Urogen Pharma	JELMYTO	mitomycin	POWDER;PYELOCALYCEAL	211728-001	Apr 15, 2020		RX	Yes	Yes			Y
Hospira	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064106-001	Nov 29, 1995		DISCN	No	No
Eugia Pharma	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	216732-001	Oct 30, 2023	AP	RX	No	No

International Patents for MITOMYCIN

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2734187	MATÉRIAUX ET MÉTHODE DE TRAITEMENT DE CAVITÉS CORPORELLES INTERNES (MATERIALS AND METHOD FOR TREATING INTERNAL BODY CAVITIES)
Israel	230530	חומרים ושיטה לטיפול בחללים של הגוף (Materials and method for treating internal body cavities)
World Intellectual Property Organization (WIPO)	2013011504
Japan	2009543608
Germany	212011100034
Japan	5448071