Mitomycin - Generic Drug Details
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What are the generic 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, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Rk Pharma, Supergen, Bristol, Bristol Myers, and Urogen Pharma, and is included in sixteen 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: | 12 |
| NDAs: | 16 |
| Drug Master File Entries: | 7 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 89 |
| Clinical Trials: | 239 |
| Patent Applications: | 5,142 |
| Formulation / Manufacturing: | see details |
| 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 |
| Columbia University | N/A |
| Varian | N/A |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol | MUTAMYCIN | mitomycin | INJECTABLE;INJECTION | 050450-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Mobius Therap | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572-001 | Feb 7, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gland Pharma Ltd | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 215687-001 | Oct 20, 2021 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hospira | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064106-001 | Nov 29, 1995 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Gland Pharma Ltd | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 216648-001 | Nov 22, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064117-001 | Apr 19, 1995 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013011504 | ⤷ Try a Trial | |
| Australia | 2007272514 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application | ⤷ Try a Trial |
| Japan | 5670546 | ⤷ Try a Trial | |
| European Patent Office | 2734187 | MATÉRIAUX ET MÉTHODE DE TRAITEMENT DE CAVITÉS CORPORELLES INTERNES (MATERIALS AND METHOD FOR TREATING INTERNAL BODY CAVITIES) | ⤷ Try a Trial |
| Germany | 212011100034 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2011089604 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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