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 1w 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 body regions, enabling clearer diagnostic visualization of internal structures. The drug has been a cornerstone diagnostic tool since approval in 1995, widely used across CT, angiography, and urography procedures.
LOE Approaching
Product faces imminent loss of exclusivity with moderate competitive pressure (30 intensity score), signaling potential team contraction and shift toward cost-containment and generic transition 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.