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Last Updated: April 5, 2025

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

Apotex	DASATINIB	dasatinib	202103	Jun 10, 2016	RX	⤷ Try for Free	⤷ Try for Free	⤷ Try for Free	PATENT CHALLENGE
Apotex	DASATINIB	dasatinib	203180	Nov 23, 2021	RX	⤷ Try for Free	⤷ Try for Free	⤷ Try for Free	PATENT CHALLENGE
Hikma	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	216899	Feb 9, 2024	RX	⤷ Try for Free	⤷ Try for Free	⤷ Try for Free	PATENT CHALLENGE
Ingenus Pharms Llc	IVABRADINE HYDROCHLORIDE	ivabradine hydrochloride	214051	Dec 30, 2021	RX	⤷ Try for Free	⤷ Try for Free	⤷ Try for Free	PATENT CHALLENGE
Rubicon	BACLOFEN	baclofen	214445	Dec 6, 2024	RX	⤷ Try for Free	⤷ Try for Free	⤷ Try for Free	PATENT CHALLENGE
>Applicant	>Tradename	>Generic Name	>NDA	>Approval Date	>Type	>Patent No.	>Patent Expiration	>Exclusivity Expiration	>Patented / Exclusive Use

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