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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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