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Last Updated: April 19, 2024

Regulatory Exclusivity: PATENT CHALLENGE

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Drugs with Patent Challenge Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Hikma	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	216159-001	Apr 17, 2023	AP	RX	No	No	⤷ Try a Trial	PATENT CHALLENGE
Hikma	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	216159-002	Apr 17, 2023	AP	RX	No	No	⤷ Try a Trial	PATENT CHALLENGE
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-001	Jul 31, 2023		DISCN	No	No	⤷ Try a Trial	PATENT CHALLENGE
Amneal	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205941-002	Jul 31, 2023		DISCN	No	No	⤷ Try a Trial	PATENT CHALLENGE
Aurobindo Pharma	SAXAGLIPTIN	saxagliptin hydrochloride	TABLET;ORAL	205972-001	Jul 31, 2023	AB	RX	No	No	⤷ Try a Trial	PATENT CHALLENGE
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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