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CHOLOGRAFIN SODIUM

NDA

IODIPAMIDE SODIUM | N009321 | BRACCO DIAGNOSTICS INC

3 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Cholografin Meglumine (2023)

Total Spending

$2K

Total Claims

744

Beneficiaries

674

ASP Price

$0.18

YoY Change:-26.6%

5yr CAGR:-8.8%

HCPCS: Q9961 — High osmolar contrast material, 250-299 mg/ml iodine concentration, per ml

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 12, 2017	SUPPL -30	View Letter (PDF)
Jul 9, 2015	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#003 — 52%

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#007 — 10.3%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#001 — 20%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.