Details for New Drug Application (NDA): 215841
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NDA 215841 describes LOCAMETZ, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LOCAMETZ profile page.
The generic ingredient in LOCAMETZ is gallium ga-68 gozetotide. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.
The generic ingredient in LOCAMETZ is gallium ga-68 gozetotide. There are sixteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.
Summary for 215841
| Tradename: | LOCAMETZ |
| Applicant: | Novartis |
| Ingredient: | gallium ga-68 gozetotide |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215841
Generic Entry Date for 215841*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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: 215841
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOCAMETZ | gallium ga-68 gozetotide | POWDER;INTRAVENOUS | 215841 | NDA | Advanced Accelerator Applications USA, Inc | 69488-017 | 69488-017-61 | 1 VIAL, MULTI-DOSE in 1 CARTON (69488-017-61) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | N/A | ||||
| Approval Date: | Mar 23, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 23, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 11,369,590 | Patent Expiration: | Aug 15, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | FOR USE AFTER RADIOLABELING WITH GALLIUM-68, FOR POSITRON EMISSION TOMOGRAPHY OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA)-POSITIVE LESIONS IN MEN WITH PROSTATE CANCER | ||||||||
| Patent: | 12,109,277 | Patent Expiration: | Mar 9, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | POSITRON EMISSION TOMOGRAPHY (PET) OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA)-POSITIVE LESIONS IN MEN WITH PROSTATE CANCER | ||||||||
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