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Last Updated: April 26, 2024

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
Hikma	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	216159	Apr 17, 2023	RX	⤷ Try a Trial	⤷ Try a Trial	⤷ Try a Trial	PATENT CHALLENGE
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	205941	Jul 31, 2023	DISCN	⤷ Try a Trial	⤷ Try a Trial	⤷ Try a Trial	PATENT CHALLENGE
Aurobindo Pharma	SAXAGLIPTIN	saxagliptin hydrochloride	205972	Jul 31, 2023	RX	⤷ Try a Trial	⤷ Try a Trial	⤷ Try a Trial	PATENT CHALLENGE
Aurobindo Pharma	PITAVASTATIN CALCIUM	pitavastatin calcium	206015	Dec 20, 2016	RX	⤷ Try a Trial	⤷ Try a Trial	⤷ Try a Trial	PATENT CHALLENGE
>Applicant	>Tradename	>Generic Name	>NDA	>Approval Date	>Type	>Patent No.	>Patent Expiration	>Exclusivity Expiration	>Patented / Exclusive Use

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