Details for New Drug Application (NDA): 214032
✉ Email this page to a colleague
The generic ingredient in ILLUCCIX 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 214032
Tradename: | ILLUCCIX |
Applicant: | Telix |
Ingredient: | gallium ga-68 gozetotide |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214032
Generic Entry Date for 214032*:
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: 214032
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ILLUCCIX | gallium ga-68 gozetotide | POWDER;INTRAVENOUS | 214032 | NDA | Telix Pharmaceuticals (US) Inc. | 74725-100 | 74725-100-25 | 1 KIT in 1 CARTON (74725-100-25) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25) |
ILLUCCIX | gallium ga-68 gozetotide | POWDER;INTRAVENOUS | 214032 | NDA | Telix Pharmaceuticals (US) Inc. | 74725-100 | 74725-100-64 | 1 KIT in 1 CARTON (74725-100-64) * 2.5 mL in 1 VIAL, MULTI-DOSE (74725-102-25) * 6.4 mL in 1 VIAL, MULTI-DOSE (74725-103-64) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE (74725-101-25) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | N/A | ||||
Approval Date: | Dec 17, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | 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 |
Complete Access Available with Subscription