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Last Updated: April 3, 2026

Safinamide - Generic Drug Details

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Generic filers with tentative approvals for SAFINAMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	100MG	TABLET;ORAL
⤷ Start Trial	⤷ Start Trial	50MG	TABLET;ORAL
⤷ Start Trial	⤷ Start Trial	50MG	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prinston Inc	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215739-001	Apr 25, 2024	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial		Y		⤷ Start Trial
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
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017	AB	RX	Yes	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

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