Last Updated: July 10, 2026

Regulatory Exclusivity Expiring in 2029

Drugs with Regulatory Exclusivity Expiring in 2029

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-001	Dec 20, 2024		RX	Yes	No	⤷ Start Trial	NEW CHEMICAL ENTITY
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730-002	Dec 20, 2024		RX	Yes	Yes	⤷ Start Trial	NEW CHEMICAL ENTITY
Xcovery	ENSACOVE	ensartinib hydrochloride	CAPSULE;ORAL	218171-001	Dec 18, 2024		RX	Yes	No	⤷ Start Trial	NEW CHEMICAL ENTITY
Xcovery	ENSACOVE	ensartinib hydrochloride	CAPSULE;ORAL	218171-002	Dec 18, 2024		RX	Yes	Yes	⤷ Start Trial	NEW CHEMICAL ENTITY
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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