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Last Updated: August 17, 2022

GALLIUM DOTATOC GA 68 Drug Patent Profile


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Which patents cover Gallium Dotatoc Ga 68, and what generic alternatives are available?

Gallium Dotatoc Ga 68 is a drug marketed by Uihc Pet Imaging and is included in one NDA.

The generic ingredient in GALLIUM DOTATOC GA 68 is gallium dotatoc ga-68. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gallium dotatoc ga-68 profile page.

Summary for GALLIUM DOTATOC GA 68
Drug patent expirations by year for GALLIUM DOTATOC GA 68
DrugPatentWatch® Estimated Generic Entry Opportunity Date for GALLIUM DOTATOC GA 68
Generic Entry Date for GALLIUM DOTATOC GA 68*:
Constraining patent/regulatory exclusivity:
FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR THE LOCALIZATION OF KNOWN SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT AND PEDIATRIC PATIENTS
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 DOTATOC GA 68

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

SponsorPhase
National Cancer Institute (NCI)Early Phase 1
M.D. Anderson Cancer CenterEarly Phase 1
NCM USAPhase 3

See all GALLIUM DOTATOC GA 68 clinical trials

US Patents and Regulatory Information for GALLIUM DOTATOC GA 68

GALLIUM DOTATOC GA 68 is protected by zero US patents and four FDA Regulatory Exclusivities.

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

This potential generic entry date is based on FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR THE LOCALIZATION OF KNOWN SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT AND PEDIATRIC PATIENTS.

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 DOTATOC GA 68

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

FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR THE LOCALIZATION OF KNOWN SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT AND PEDIATRIC PATIENTS
Exclusivity Expiration: 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
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
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 See Plans and Pricing See Plans and Pricing
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 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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Serving leading biopharmaceutical companies globally:

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McKesson

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.