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Last Updated: June 12, 2021

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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 NDA Approval Date Type Patent No. Patent Expiration Exclusivity Expiration Patented / Exclusive Use
Uihc Pet Imaging GALLIUM DOTATOC GA 68 gallium dotatoc ga-68 210828 Aug 21, 2019 RX   Get Started Free   Get Started Free   Get Started Free 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 200655 Oct 10, 2019 DISCN   Get Started Free   Get Started Free   Get Started Free 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 212642 Dec 1, 2020 RX   Get Started Free   Get Started Free   Get Started Free 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 212643 Dec 1, 2020 RX   Get Started Free   Get Started Free   Get Started Free 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 >NDA >Approval Date >Type >Patent No. >Patent Expiration >Exclusivity Expiration >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Baxter
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Harvard Business School
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Medtronic

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