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Last Updated: June 28, 2022

GALLIUM GA 68 PSMA-11 Drug Patent 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. One supplier is listed for this compound. Additional details are available on the gallium ga-68 psma-11 profile page.

Summary for GALLIUM GA 68 PSMA-11
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
Universidade Federal do ParaN/A
Eli Lilly and CompanyPhase 1/Phase 2
Prostate Cancer FoundationPhase 1/Phase 2

See all GALLIUM GA 68 PSMA-11 clinical trials

Pharmacology for GALLIUM GA 68 PSMA-11

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

GALLIUM GA 68 PSMA-11 is protected by zero US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GALLIUM GA 68 PSMA-11 is See Plans and Pricing.

This potential generic entry date is based on EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting GALLIUM GA 68 PSMA-11

EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing
>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.