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: | 3,175 |
Drug Prices: | Drug price trends for mitomycin |
What excipients (inactive ingredients) are in mitomycin? | mitomycin excipients list |
DailyMed Link: | mitomycin at DailyMed |
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 |
Pharmacology for mitomycin
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for mitomycin
Anatomical Therapeutic Chemical (ATC) Classes for mitomycin
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol Myers | MUTAMYCIN | mitomycin | INJECTABLE;INJECTION | 062336-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Bristol | MUTAMYCIN | mitomycin | INJECTABLE;INJECTION | 050450-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Urogen Pharma | JELMYTO | mitomycin | POWDER;PYELOCALYCEAL | 211728-001 | Apr 15, 2020 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Bristol | MUTAMYCIN | mitomycin | INJECTABLE;INJECTION | 050450-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Meitheal | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 214504-001 | Sep 6, 2022 | AP | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Accord Hlthcare | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064144-003 | Aug 11, 2009 | AP | RX | No | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Mobius Therap | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572-001 | Feb 7, 2012 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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
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) | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2011089604 | ⤷ Try for Free | |
European Patent Office | 2525777 | MATÉRIEL ET PROCÉDÉ DE TRAITEMENT DE CAVITÉS INTERNES (MATERIAL AND METHOD FOR TREATING INTERNAL CAVITIES) | ⤷ Try for Free |
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) | ⤷ Try for Free |
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) | ⤷ Try for Free |
World Intellectual Property Organization (WIPO) | 2008008802 | ⤷ Try for Free | |
World Intellectual Property Organization (WIPO) | 2013011504 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Mitomycin Market Dynamics and Financial Trajectory
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