Safinamide - Generic Drug Details
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Generic filers with tentative approvals for SAFINAMIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Free Trial | ⤷ Free Trial | 100MG | TABLET;ORAL |
⤷ Free Trial | ⤷ Free Trial | 50MG | TABLET;ORAL |
⤷ Free Trial | ⤷ Free Trial | 100MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-002 | Mar 21, 2017 | AB | RX | Yes | Yes | 8,278,485 | ⤷ Free Trial | Y | ⤷ Free Trial | ||
Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-001 | Mar 21, 2017 | AB | RX | Yes | No | 8,076,515 | ⤷ Free Trial | Y | Y | ⤷ Free Trial | |
Prinston Inc | SAFINAMIDE MESYLATE | safinamide mesylate | TABLET;ORAL | 215739-001 | Apr 25, 2024 | AB | RX | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | |||
Aurobindo Pharma | SAFINAMIDE MESYLATE | safinamide mesylate | TABLET;ORAL | 215902-001 | Jun 14, 2023 | DISCN | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | ||||
Prinston Inc | SAFINAMIDE MESYLATE | safinamide mesylate | TABLET;ORAL | 215739-002 | Apr 25, 2024 | AB | RX | No | No | ⤷ Free Trial | ⤷ Free Trial | ⤷ Free Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |