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Last Updated: March 25, 2026

Regulatory Exclusivity: PATENT CHALLENGE

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Drugs with Patent Challenge Regulatory Exclusivity

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Applicant	Tradename	Generic Name	NDA	Approval Date	Type	Patent No.	Patent Expiration	Exclusivity Expiration	Patented / Exclusive Use
Alkem Labs Ltd	TOPIRAMATE	topiramate	217795	Oct 31, 2024	RX	⤷ Start Trial	⤷ Start Trial	⤷ Start Trial	PATENT CHALLENGE
Baxter Hlthcare Corp	ACETAMINOPHEN	acetaminophen	214331	May 21, 2025	RX	⤷ Start Trial	⤷ Start Trial	⤷ Start Trial	PATENT CHALLENGE
Natco Pharma Ltd	BOSENTAN	bosentan	213154	Feb 5, 2025	RX	⤷ Start Trial	⤷ Start Trial	⤷ Start Trial	PATENT CHALLENGE
Fresenius Kabi Usa	EPHEDRINE SULFATE	ephedrine sulfate	218271	Mar 11, 2025	RX	⤷ Start Trial	⤷ Start Trial	⤷ Start Trial	PATENT CHALLENGE
Teva Pharms	LIRAGLUTIDE	liraglutide	214568	Aug 27, 2025	RX	⤷ Start Trial	⤷ Start Trial	⤷ Start Trial	PATENT CHALLENGE
Ph Health	GLYCEROL PHENYLBUTYRATE	glycerol phenylbutyrate	205742	Dec 2, 2021	RX	⤷ Start Trial	⤷ Start Trial	⤷ Start Trial	PATENT CHALLENGE
>Applicant	>Tradename	>Generic Name	>NDA	>Approval Date	>Type	>Patent No.	>Patent Expiration	>Exclusivity Expiration	>Patented / Exclusive Use

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