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
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 5 |
| DailyMed Link: | GALLIUM DOTATOC GA 68 at DailyMed |
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
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Early Phase 1 |
| National Cancer Institute (NCI) | Early Phase 1 |
| Charito Love | Phase 3 |
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 |
