FOSFOMYCIN TROMETHAMINE - Generic Drug Details
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What are the generic drug sources for fosfomycin tromethamine and what is the scope of patent protection?
Fosfomycin tromethamine
is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal, Cipla, Xiromed, and Zambon Spa, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for fosfomycin tromethamine. Six suppliers are listed for this compound.
Summary for FOSFOMYCIN TROMETHAMINE
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 5 |
| NDAs: | 5 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 5 |
| Patent Applications: | 869 |
| Drug Prices: | Drug price trends for FOSFOMYCIN TROMETHAMINE |
| What excipients (inactive ingredients) are in FOSFOMYCIN TROMETHAMINE? | FOSFOMYCIN TROMETHAMINE excipients list |
| DailyMed Link: | FOSFOMYCIN TROMETHAMINE at DailyMed |
Recent Clinical Trials for FOSFOMYCIN TROMETHAMINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Benova (Tianjin) Innovative medicine Research Co., Ltd. | Phase 3 |
| Saltro | Phase 3 |
| MJM Bonten | Phase 3 |
Medical Subject Heading (MeSH) Categories for FOSFOMYCIN TROMETHAMINE
Anatomical Therapeutic Chemical (ATC) Classes for FOSFOMYCIN TROMETHAMINE
US Patents and Regulatory Information for FOSFOMYCIN TROMETHAMINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alkem Labs Ltd | FOSFOMYCIN TROMETHAMINE | fosfomycin tromethamine | FOR SOLUTION;ORAL | 214554-001 | Oct 21, 2021 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zambon Spa | MONUROL | fosfomycin tromethamine | FOR SOLUTION;ORAL | 050717-001 | Dec 19, 1996 | AA | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Xiromed | FOSFOMYCIN TROMETHAMINE | fosfomycin tromethamine | FOR SOLUTION;ORAL | 212548-001 | Oct 6, 2020 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Cipla | FOSFOMYCIN TROMETHAMINE | fosfomycin tromethamine | FOR SOLUTION;ORAL | 211881-001 | Jan 26, 2022 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
