Details for New Drug Application (NDA): 219592
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NDA 219592 describes GOZELLIX, which is a drug marketed by Telix Innovations and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the GOZELLIX profile page.
The generic ingredient in GOZELLIX is gallium ga-68 gozetotide. There are sixteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.
The generic ingredient in GOZELLIX is gallium ga-68 gozetotide. There are sixteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the gallium ga-68 gozetotide profile page.
Summary for 219592
| Tradename: | GOZELLIX |
| Applicant: | Telix Innovations |
| Ingredient: | gallium ga-68 gozetotide |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219592
Generic Entry Date for 219592*:
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: 219592
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GOZELLIX | gallium ga-68 gozetotide | POWDER;INTRAVENOUS | 219592 | NDA | Telix Innovations SA | 84552-500 | 84552-500-25 | 1 KIT in 1 CARTON (84552-500-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25) |
| GOZELLIX | gallium ga-68 gozetotide | POWDER;INTRAVENOUS | 219592 | NDA | Telix Innovations SA | 84552-500 | 84552-500-64 | 1 KIT in 1 CARTON (84552-500-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (84552-502-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (84552-503-64) * 2 mL in 1 AMPULE (84552-504-25) * 1 POWDER, FOR SOLUTION in 1 VIAL, MULTI-DOSE (84552-501-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | N/A | ||||
| Approval Date: | Mar 20, 2025 | TE: | RLD: | Yes | |||||
| Patent: | 11,027,031 | Patent Expiration: | Jul 28, 2035 | 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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