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GALLIUM DOTATATE GA-68 | N208547 | ADVANCED ACCELERATOR APPLICATIONS USA INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

2031

2032

Today

Aug. 10, 2032

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

3 trials from ClinicalTrials.gov — 2 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Heart Analysis in GATED-PET in Patients Having a Gallium-68-DOTATOC PET/CT Exam for Oncology Indication NCT06467968	N/A	Recruiting	Central Hospital, Nancy, France	99	2023-02-02 → 2027-05-26
Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR+ Gastrointestinal Neuroendocrine Tumor and Pheochromocytoma/Paraganglioma Previously Treated With Systemic Targeted Radioligand Therapy NCT06427798	Phase 1/2	Recruiting	National Cancer Institute (NCI)	66	2025-02-07 → 2039-07-01
Pilot Study Evaluating Somatostatin Receptor's PET Imaging to Detect Inflammatory Phases of Myocarditis NCT03347760	N/A	Completed	Central Hospital, Nancy, France	33	2020-07-13 → 2023-12-13

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

Approval Letters

8 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.1-5.5mCi/ML

RLD

1 patent0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jun 1, 2016

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9375498	Aug 10, 2032	—	—	Yes	—	—