MITOMYCIN Drug Patent Profile
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When do Mitomycin patents expire, and what generic alternatives are available?
Mitomycin is a drug marketed by Accord Hlthcare, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Meitheal, and Rk Pharma. and is included in eleven NDAs.
The generic ingredient in MITOMYCIN is mitomycin. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mitomycin
A generic version of MITOMYCIN was approved as mitomycin by HIKMA on April 19th, 1995.
Summary for MITOMYCIN
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 89 |
| Clinical Trials: | 239 |
| Patent Applications: | 5,071 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MITOMYCIN |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064144-001 | Apr 30, 1998 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Meitheal | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 214504-001 | Sep 6, 2022 | AP | RX | No | No | ⤷ 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 | |||
| Eugia Pharma | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 216732-001 | Oct 30, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 064117-002 | Apr 19, 1995 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rk Pharma | MITOMYCIN | mitomycin | INJECTABLE;INJECTION | 202670-002 | Oct 13, 2017 | AP | RX | 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 |
