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Last Updated: May 24, 2022

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
Uihc Pet Imaging GALLIUM DOTATOC GA 68 gallium dotatoc ga-68 SOLUTION;INTRAVENOUS 210828-001 Aug 21, 2019 RX Yes Yes See Plans and Pricing 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 See Plans and Pricing EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
Univ Ca Los Angeles GALLIUM GA 68 PSMA-11 gallium ga-68 psma-11 SOLUTION;INTRAVENOUS 212642-001 Dec 1, 2020 RX Yes Yes See Plans and Pricing EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
Univ Of Ca San Fran GALLIUM GA 68 PSMA-11 gallium ga-68 psma-11 SOLUTION;INTRAVENOUS 212643-001 Dec 1, 2020 RX Yes Yes See Plans and Pricing 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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