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FLUDEOXYGLUCOSE F18

NDA

FLUDEOXYGLUCOSE F-18 | N020306 | DOWNSTATE CLINICAL PET CENTER

2 strengths0 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

20 trials from ClinicalTrials.gov — 10 recruiting, 3 active, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer NCT03811015	Phase 3	Active	National Cancer Institute (NCI)	636	2019-08-16 → 2027-01-01
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers NCT07118176	Phase 1	Active	Jonsson Comprehensive Cancer Center	30	2025-08-01 → 2027-09-07
De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer NCT03952585	Phase 2/3	Active	National Cancer Institute (NCI)	384	2019-10-09 → 2026-12-11
GPRC5D Targeted PET/CT Imaging in Plasma Cell Disorders NCT07660939	Phase 1	Not Yet Recruiting	Peking University First Hospital	50	2026-06-25 → 2027-05-25
18F-Fluciclovine PET/CT in Multiple Myeloma NCT06103838	Phase 2	Recruiting	National Cancer Institute (NCI)	60	2024-03-25 → 2032-12-06
GPC3-Targeted PET/CT in Hepatocellular Carcinoma NCT07677774	N/A	Recruiting	The First Affiliated Hospital of Xiamen University	40	2026-05-01 → 2028-05-31
DLL3-Targeted PET/CT in Small Cell Lung Cancer NCT07677787	N/A	Recruiting	The First Affiliated Hospital of Xiamen University	20	2026-05-09 → 2028-05-31
Intermittent Cold Exposure and Brown Adipose Tissue Hyperplasia NCT07048405	N/A	Recruiting	University of Edinburgh	12	2025-05-01 → 2027-07
Effects of Exogenous Ketones on Cognitive Function in Older Adults With Prediabetes?NCT07546409	N/A	Recruiting	University of Alabama at Birmingham	20	2025-05-20 → 2027-05-31
Intracranial Genetically Modified Immune Cells (TGFβR2KO/IL13Rα2 CAR T-Cells) for the Treatment of Recurrent or Progressive Glioblastoma or Grade 3 or 4 IDH-Mutant Astrocytoma NCT06815029	Phase 1	Recruiting	City of Hope Medical Center	27	2025-06-17 → 2030-10-11

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

API Supply Chain0 active DMFs2 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

INSTITUTE CLINICAL PETInactiveFLUDEOXYGLUCOSE F-18 INJECTION

DMF 90571991

GENERAL ELECTRIC MEDICAL SYSTEMSInactiveFLUDEOXYGLUCOSE F-18 INJECTION

DMF 132681998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 10, 2004	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 4-40mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 19, 1994

No patent or exclusivity listings for this strength.

#002 — 4-90mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 25, 2001