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:	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
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
Eugia Pharma	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	216732-002	Oct 30, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	216732-001	Oct 30, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064144-001	Apr 30, 1998	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064144-003	Aug 11, 2009	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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
Japan	2014097399	APPARATUS AND METHOD FOR RECONSTITUTING PHARMACEUTICAL AND PREPARING RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION	⤷ Sign Up
Japan	2009543608		⤷ Sign Up
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)	⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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