Details for New Drug Application (NDA): 210828
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NDA 210828 describes GALLIUM GA 68 EDOTREOTIDE, which is a drug marketed by Uihc Pet Imaging and is included in one NDA. It is available from one supplier. Additional details are available on the GALLIUM GA 68 EDOTREOTIDE profile page.
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.
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.
Summary for 210828
| Tradename: | GALLIUM GA 68 EDOTREOTIDE |
| Applicant: | Uihc Pet Imaging |
| Ingredient: | gallium ga-68 edotreotide |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210828
Generic Entry Date for 210828*:
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 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.
Suppliers and Packaging for NDA: 210828
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GALLIUM GA 68 EDOTREOTIDE | gallium ga-68 edotreotide | SOLUTION;INTRAVENOUS | 210828 | NDA | UIHC ? P E T Imaging Center | 24417-681 | 24417-681-30 | 14 mL in 1 VIAL, MULTI-DOSE (24417-681-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.5-4mCi/ML | ||||
| Approval Date: | Aug 21, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR THE LOCALIZATION OF KNOWN SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT AND PEDIATRIC PATIENTS | ||||||||
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