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Last Updated: November 28, 2023

Regulatory Exclusivity: EXCLUSIVITY WAIVED BY SPONSOR

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Drugs with Exclusivity Waived By Sponsor Regulatory Exclusivity

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Exclusivity Expiration	Patented / Exclusive Use
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529-001	May 26, 2020		RX	Yes	Yes	⤷ Try a Trial	EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
Uihc Pet Imaging	GALLIUM GA 68 EDOTREOTIDE	gallium ga-68 edotreotide	SOLUTION;INTRAVENOUS	210828-001	Aug 21, 2019		RX	Yes	Yes	⤷ Try a Trial	EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
Feinstein	FLUORODOPA F18	fluorodopa f-18	SOLUTION;INTRAVENOUS	200655-001	Oct 10, 2019		RX	Yes	Yes	⤷ Try a Trial	EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Exclusivity Expiration	>Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson

Baxter

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