NDAINJECTION, ORALSOLUTION
Approved
Oct 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
OMNIPAQUE 350 (iohexol) by GE HealthCare is x-ray contrast activity [moa]. Approved for radiographic contrast agent [epc]. First approved in 1995.
Drug data last refreshed 4h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMNIPAQUE 350 is an iohexol-based radiographic contrast agent administered via injection or oral route as a solution. It enhances X-ray imaging by increasing radiodensity in targeted anatomical regions, enabling clearer visualization during diagnostic procedures. The product serves as a non-ionic, low-osmolar contrast medium for a broad range of radiological examinations.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), indicating potential team downsizing and shift toward lifecycle management and generic defense strategies.
Mechanism of Action
X-Ray Contrast Activity
Pharmacologic Class:
Radiographic Contrast Agent
Indications (1)
Clinical Trials (4)
Relative Bioavailability of CE-Iohexol (Captisol-enabled™ Iohexol) Injection and Omnipaque™ Injection
Started Apr 2019
24 enrolled
Contrast-induced NephropathyCoronary Angiography
A Study of the Effect of Abemaciclib on Metformin and Iohexol in Healthy Participants
Started Aug 2016
40 enrolled
Healthy
Oral Iohexol for Fecal/Fluid Tagging for CT Colonography: A Study to Improve Image Quality by Preventing Colonic Bubbles
Started Feb 2013
84 enrolled
Colorectal Neoplasms
A Phase 1, Open Label, Placebo-Controlled Study to Evaluate the Effect of GSK1349572 on Iohexol and Para-Aminohippurate Clearance in Healthy Subjects
Started Oct 2010
38 enrolled
Infections, Human Immunodeficiency Virus and Tuberculosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.