MONUROL Drug Patent Profile
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When do Monurol patents expire, and what generic alternatives are available?
Monurol is a drug marketed by Zambon Spa and is included in one NDA.
The generic ingredient in MONUROL is fosfomycin tromethamine. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fosfomycin tromethamine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Monurol
A generic version of MONUROL was approved as fosfomycin tromethamine by XIROMED on October 6th, 2020.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MONUROL?
- What are the global sales for MONUROL?
- What is Average Wholesale Price for MONUROL?
Summary for MONUROL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 17 |
| Clinical Trials: | 4 |
| Drug Prices: | Drug price information for MONUROL |
| What excipients (inactive ingredients) are in MONUROL? | MONUROL excipients list |
| DailyMed Link: | MONUROL at DailyMed |
Recent Clinical Trials for MONUROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Gerencia de Atención Primaria, Madrid | Phase 4 |
| Jordi Gol i Gurina Foundation | Phase 4 |
| Balearic Islands Health Service (Ibsalut) | Phase 4 |
US Patents and Regulatory Information for MONUROL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zambon Spa | MONUROL | fosfomycin tromethamine | FOR SOLUTION;ORAL | 050717-001 | Dec 19, 1996 | AA | RX | Yes | Yes | ⤷ 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 |
