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DATSCAN

NDA

IOFLUPANE I-123 | N022454 | GE HEALTHCARE INC

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition Amendment from Quagen Pharma LLC FDA-2026-P-8560 · 5 docket documents Quagen Pharma LLC filed an amendment to a suitability petition regarding the use of a non-compendial excipient in pharmaceutical formulations, requesting that the FDA grant a determination of suitability for the excipient's use in drug products subject to NDA or ANDA approval.	Suitability	2026-08-20	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

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

Trial	Phase	Status	Sponsor	Enrollment	Dates
DaTSCAN Imaging in Aging and Neurodegenerative Disease NCT01453127	Phase 4	By Invitation	Mayo Clinic	500	2011-10 → 2026-12
A Study to Assess Changes in Clinical Management After DaTSCAN Imaging of Subjects With Clinically Uncertain Parkinsonism or an Illness With Similar Symptoms NCT00382967	Phase 4	Completed	GE Healthcare	273	2006-10 → 2011-01

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1389.38

Highest Price

$2311.56

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
17156-0210-01I-123 DATSCAN	$1389.38	Big4	Medi-Physics, Inc. dba GE Healthcare	07/31/2028
17156-0210-01I-123 DATSCAN	$2311.56	FSS	Medi-Physics, Inc. dba GE Healthcare	07/31/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 5mCi/2.5ML (2mCi/ML)

RLDAP

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jan 14, 2011

No patent or exclusivity listings for this strength.