Last Updated: June 2, 2026

Vortioxetine - Generic Drug Details

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Generic filers with tentative approvals for VORTIOXETINE

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	15MG	TABLET;ORAL
⤷ Start Trial	⤷ Start Trial	10MG	TABLET;ORAL
⤷ Start Trial	⤷ Start Trial	5MG	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 vortioxetine

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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
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No	8,722,684*PED	⤷ Start Trial			Y	⤷ Start Trial
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-003	Sep 30, 2013		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Takeda Pharms Usa	TRINTELLIX	vortioxetine hydrobromide	TABLET;ORAL	204447-001	Sep 30, 2013		RX	Yes	No	9,125,910*PED	⤷ Start Trial			Y	⤷ 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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