Last Updated: July 28, 2026

Maci - Generic Drug Details

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Generic filers with tentative approvals for MACI

Applicant	Application No.	Strength	Dosage Form
⤷ Start Trial	⤷ Start Trial	10MG	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 maci

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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
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial			Y	⤷ Start Trial
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Apotex	MACITENTAN	macitentan	TABLET;ORAL	211195-001	Jan 9, 2024	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Teva Pharms Usa Inc	MACITENTAN	macitentan	TABLET;ORAL	211187-001	Jun 8, 2026	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Laurus	MACITENTAN	macitentan	TABLET;ORAL	211120-001	Nov 5, 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

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