GALLIUM GA 68 EDOTREOTIDE Drug Patent Profile
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When do Gallium Ga 68 Edotreotide patents expire, and when can generic versions of Gallium Ga 68 Edotreotide launch?
Gallium Ga 68 Edotreotide is a drug marketed by Uihc Pet Imaging and is included in one NDA.
The generic ingredient in GALLIUM GA 68 EDOTREOTIDE is gallium ga-68 edotreotide. 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 edotreotide profile page.
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Summary for GALLIUM GA 68 EDOTREOTIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| DailyMed Link: | GALLIUM GA 68 EDOTREOTIDE at DailyMed |
Recent Clinical Trials for GALLIUM GA 68 EDOTREOTIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | Phase 3 |
| National Cancer Institute (NCI) | Early Phase 1 |
| M.D. Anderson Cancer Center | Early Phase 1 |
US Patents and Regulatory Information for GALLIUM GA 68 EDOTREOTIDE
GALLIUM GA 68 EDOTREOTIDE is protected by zero US patents and four FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting GALLIUM GA 68 EDOTREOTIDE
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: ⤷ Sign Up
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
| 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 GA 68 EDOTREOTIDE | gallium ga-68 edotreotide | SOLUTION;INTRAVENOUS | 210828-001 | Aug 21, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Uihc Pet Imaging | GALLIUM GA 68 EDOTREOTIDE | gallium ga-68 edotreotide | SOLUTION;INTRAVENOUS | 210828-001 | Aug 21, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
