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GALLIUM GA 68 GOZETOTIDE

NDA

GALLIUM GA-68 GOZETOTIDE | N212642 | UNIV CALIFORNIA LOS ANGELES

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

4 trials from ClinicalTrials.gov — 1 recruiting, 2 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer NCT04419402	Phase 2	Active	Australian and New Zealand Urogenital and Prostate Cancer Trials Group	162	2020-08-17 → 2026-12-01
Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT NCT05983198	Phase 1	Active	Novartis Pharmaceuticals	33	2023-11-07 → 2031-03-04
Response With Interim PSMA PET in Metastatic Castration-sensitive Prostate Cancer for Optimization of Adaptive Metastasis-directed Radiotherapy Delivery NCT07674771	Early Phase 1	Not Yet Recruiting	University of Texas Southwestern Medical Center	30	2026-07-15 → 2029-06-15
Comparison of Changes in Tumor Burden in 68Ga-PSMA-11 PET/CT and 177Lu-PSMA SPECT/CT in Metastatic Castration-resistant Prostate Cancer NCT06461689	—	Completed	Central Hospital, Nancy, France	80	2024-12-31 → 2025-02-28

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5-5mCi/mL

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Dec 1, 2020

No patent or exclusivity listings for this strength.