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Last Updated: June 25, 2021

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GALLIUM GA 68 PSMA-11 Drug Profile


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When do Gallium Ga 68 Psma-11 patents expire, and when can generic versions of Gallium Ga 68 Psma-11 launch?

Gallium Ga 68 Psma-11 is a drug marketed by Univ Ca Los Angeles and Univ Of Ca San Fran and is included in two NDAs.

The generic ingredient in GALLIUM GA 68 PSMA-11 is gallium ga-68 psma-11. There are sixteen drug master file entries for this compound. Additional details are available on the gallium ga-68 psma-11 profile page.

Summary for GALLIUM GA 68 PSMA-11
US Patents:0
Applicants:2
NDAs:2
Clinical Trials: 103
DailyMed Link:GALLIUM GA 68 PSMA-11 at DailyMed
Drug patent expirations by year for GALLIUM GA 68 PSMA-11
DrugPatentWatch® Estimated Generic Entry Opportunity Date for GALLIUM GA 68 PSMA-11
Generic Entry Dates for GALLIUM GA 68 PSMA-11*:
Constraining patent/regulatory exclusivity:
EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
NDA:
Dosage:
SOLUTION;INTRAVENOUS
Generic Entry Dates for GALLIUM GA 68 PSMA-11*:
Constraining patent/regulatory exclusivity:
EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GALLIUM GA 68 PSMA-11

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Norbert Avril, M.D.Phase 3
POINT BiopharmaPhase 1/Phase 2
Emory UniversityPhase 1

See all GALLIUM GA 68 PSMA-11 clinical trials

US Patents and Regulatory Information for GALLIUM GA 68 PSMA-11

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Univ Ca Los Angeles GALLIUM GA 68 PSMA-11 gallium ga-68 psma-11 SOLUTION;INTRAVENOUS 212642-001 Dec 1, 2020 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
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   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.