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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, Hospira, Rk Pharma, West-ward Pharms Int, Supergen, Bristol, Bristol Myers, and Urogen Pharma, and is included in eleven 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. Six suppliers are listed for this compound.
Summary for mitomycin
International Patents: | 18 |
US Patents: | 7 |
Tradenames: | 5 |
Applicants: | 9 |
NDAs: | 11 |
Drug Master File Entries: | 7 |
Suppliers / Packagers: | 6 |
Bulk Api Vendors: | 74 |
Clinical Trials: | 215 |
Patent Applications: | 7,364 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for mitomycin |
DailyMed Link: | mitomycin at DailyMed |
Recent Clinical Trials for mitomycin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Kaplan Medical Center | Phase 2 |
Michele Reni | Phase 2 |
Asmaa Ahmed Ali Youssif | Early Phase 1 |
Pharmacology for mitomycin
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
West-ward Pharms Int | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064117-001 | Apr 19, 1995 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Accord Hlthcare | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064144-001 | Apr 30, 1998 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
West-ward Pharms Int | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064180-002 | Dec 23, 1999 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Mobius Therap | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572-001 | Feb 7, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Rk Pharma | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 202670-001 | Oct 13, 2017 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
>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 | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2008008802 | Start Trial |
Spain | 2732150 | Start Trial |
Japan | 2014097399 | Start Trial |
World Intellectual Property Organization (WIPO) | 2013011504 | Start Trial |
European Patent Office | 2734187 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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