Details for New Drug Application (NDA): 215841
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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: | ⤷ Sign Up | 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: | ⤷ Sign Up | 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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