SAFINAMIDE Drug Patent Profile
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When do Safinamide patents expire, and what generic alternatives are available?
Safinamide is a drug marketed by Aurobindo Pharma, MSN, Prinston Inc, and Zenara. and is included in four NDAs.
The generic ingredient in SAFINAMIDE is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Safinamide
A generic version of SAFINAMIDE was approved as safinamide mesylate by PRINSTON INC on April 25th, 2024.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for SAFINAMIDE?
- What are the global sales for SAFINAMIDE?
- What is Average Wholesale Price for SAFINAMIDE?
Summary for SAFINAMIDE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| DailyMed Link: | SAFINAMIDE at DailyMed |
US Patents and Regulatory Information for SAFINAMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma | SAFINAMIDE MESYLATE | safinamide mesylate | TABLET;ORAL | 215902-001 | Jun 14, 2023 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Zenara | SAFINAMIDE MESYLATE | safinamide mesylate | TABLET;ORAL | 215913-001 | Jun 13, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Msn | SAFINAMIDE MESYLATE | safinamide mesylate | TABLET;ORAL | 215978-002 | Dec 31, 2024 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Zenara | SAFINAMIDE MESYLATE | safinamide mesylate | TABLET;ORAL | 215913-002 | Jun 13, 2025 | AB | 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 |
