Last updated: July 28, 2026
Omnipaque 210 (iohexol 210 mgI/mL) is a non-ionic, water-soluble iodinated contrast media used for X-ray imaging. Current public sources do not provide a complete, drug-specific clinical-trials calendar for Omnipaque 210 alone (as distinct from “iohexol” and class-wide iodinated contrast research). Market outlook is therefore driven by (1) steady demand for iodinated contrast in CT/angiography and (2) competitive dynamics within iohexol brands and alternatives (iopamidol, ioversol, iodixanol), rather than by identifiable Omnipaque 210-only late-stage pipelines in public filings.
Clinical trials update (Omnipaque 210 vs. iohexol class)
Public trial registries and sponsor announcements commonly group iodinated contrast studies at the active-ingredient level (iohexol) or evaluate device protocols, injection rates, renal-safety endpoints, and dose strategies. Without reliable, Omnipaque-210-specific late-stage entries in the public record, the best-supported “update” is that ongoing activity is largely protocol- and comparative-style rather than new-molecule development.
What types of “current” studies typically cover for iohexol brands
- Renal safety and contrast-associated acute kidney injury (CIAKI/CA-AKI) risk stratification, including hydration strategy comparisons.
- Hypersensitivity risk mitigation and premedication approaches.
- Optimization of imaging parameters: injection rate, volume, dual-phase protocols, and low-osmolality/low-volume strategies.
- Comparative trials vs. other iodinated agents (non-ionic monomers and dimers) and vs. other iohexol formulations (same active, different concentration/packaging).
Market context: Omnipaque 210 sits inside the iohexol iodinated contrast market
- Omnipaque is marketed across multiple concentrations; 210 is positioned for indications where lower iodine concentration and/or imaging-specific dosing is used.
- The market is mature. Competitive advantage is typically determined by contracting formularies, hospital procurement, supply reliability, cold-chain or handling requirements (by presentation), and pharmacovigilance performance rather than by incremental clinical trial wins for a specific concentration.
What clinical trials are active for Omnipaque 210 (iohexol 210 mgI/mL) right now?
Answer: Publicly available updates for iodinated contrast are predominantly iohexol-class studies (not Omnipaque-210-specific), usually focused on imaging protocols, renal safety, or hypersensitivity mitigation rather than on new chemical entities.
Trial-signal categories to track for Omnipaque 210 exposure
- Renal risk reduction studies
Endpoints typically include change in serum creatinine/eGFR, staging by KDIGO, and biomarker panels.
- Hypersensitivity and premedication
Studies assess risk scores, premedication regimens, and emergency medication readiness workflows.
- Dose-injection optimization
Protocol work targets contrast enhancement adequacy at lower dose or altered injection rates.
- Comparative effectiveness
Direct comparisons with other iodinated contrasts focus on image quality, adverse event rates, and operational workflow.
Why Omnipaque 210 may appear “quiet” in registries
- Sponsors often register studies at the active ingredient (iohexol) level, or they enroll mixed iodinated contrast cohorts with brand-level labeling.
- Concentration-level studies are less common because clinical use is typically determined by dosing algorithms and institutional protocols rather than by new clinical evidence for each concentration.
How does Omnipaque 210 perform in market share versus other iodinated contrast agents?
Answer: Omnipaque competes within a crowded, mature iodinated contrast market where market share is driven by formulary access and procurement economics, with technical differentiation usually limited to concentration, viscosity, osmolality, and presentation.
Competitive set (typical alternatives in the same imaging pathway)
- Iopamidol (non-ionic; often used in CT and angiography settings)
- Ioversol (non-ionic; widely used in CT)
- Iodixanol (dimer; often selected in some renal-safety frameworks)
- Other iohexol presentations (same active ingredient; different concentrations and packaging)
Practical drivers of Omnipaque 210 adoption
- Tender pricing and group purchasing organization (GPO) contracts.
- Conversion resistance in hospital procurement due to switching costs and established imaging protocols.
- Supply continuity and lot-to-lot consistency.
- Adverse event profile and pharmacovigilance signals at the hospital level (often brand-driven in practice).
When will Omnipaque 210 face generic or competitive pressure?
Answer: Omnipaque 210 is a legacy small-molecule brand in a mature category where the main competitive pressure typically comes from (1) generic iohexol equivalents and (2) competing branded iodinated contrast products, rather than from a single, concentration-specific exclusivity event in the current period.
What to monitor for “entry risk” in this category
- FDA approvals for generic iohexol products with equivalent concentration and route.
- Labeling parity and manufacturing consistency (particulates, osmolality, viscosity ranges).
- Tender cycles that shift volume from one brand to another.
What is the Orange Book status of Omnipaque 210 and how many patents block generic entry?
Answer: A concentration-specific Orange Book analysis requires the exact NDA and listed patents for Omnipaque 210. Publicly searchable patent and Orange Book mapping for “Omnipaque 210” is often embedded in broader Omnipaque NDA listings across concentrations and presentations, making a complete count concentration-dependent.
(No complete, defensible Orange Book status and patent count can be produced from the information available in this request.)
What dosing and imaging indications drive Omnipaque 210 demand?
Answer: Demand is tied to routine radiology use for CT and angiography workflows where iodinated contrast is administered and where 210 mgI/mL provides dosing flexibility.
Indication buckets that typically matter commercially
- CT imaging with IV contrast
- X-ray/angiography use cases
- Body imaging protocols that use concentration-adjusted dosing and injection rates
Commercial relevance of concentration 210
- Concentration-level use affects:
- Volume required to reach iodine dose targets
- Viscosity and injection protocol compatibility
- Institutional dosing algorithms and contrast preparation workflow
How strong is the competitive pipeline for iohexol and does it change Omnipaque 210 pricing?
Answer: The “pipeline” in iodinated contrast is more often line extensions, manufacturing improvements, and presentation changes than new, differentiating clinical efficacy breakthroughs. That limits pricing power gains for a single concentration unless procurement shifts favor the brand.
What typically moves pricing in this market
- Generic penetration cycles
- Availability constraints (supply shocks)
- Contract renewals by hospital systems
- Substitution behavior based on adverse events and formulary updates
Market analysis: what is the size of the iodinated contrast market relevant to Omnipaque 210?
Answer: Omnipaque 210 participates in the global iodinated contrast media market used primarily in CT and related imaging. The sector is mature, with growth driven by:
- Rising imaging volume (CT share and overall imaging throughput)
- Aging populations and higher prevalence of conditions requiring cross-sectional imaging
- Ongoing adoption in emergency and outpatient settings
- Incremental shifts among contrast agents rather than major category expansion
(A complete Omnipaque 210-specific revenue forecast requires Omnipaque brand revenue, concentration mix, and audited distributor data, none provided in this request.)
2025+ market projection: what outcomes are most likely for Omnipaque 210 revenue and share?
Answer: The most likely profile for Omnipaque 210 is stable-to-modest revenue growth driven by imaging demand, offset by competitive substitution within iodinated contrast media and by generic erosion if pricing pressure increases at tender renewal.
Projection framework (directional, category-consistent)
- Volume growth: supported by continued CT imaging expansion and clinical reliance on iodinated contrast.
- Net price: pressured by procurement competition, with potential periods of stabilization when contracts favor supply reliability.
- Share: tends to shift at contract renewal boundaries rather than continuously; outcomes hinge on tender pricing and hospital formulary decisions.
“Base, upside, downside” scenario levers
- Upside: favorable contract renewals, supply stability, and clinician preference sustaining share.
- Downside: aggressive tender pricing from generics or competing brands plus substitution driven by procurement cycles.
- Neutral: moderate category growth with flat share.
(A quantified forecast cannot be produced without source-backed Omnipaque 210 revenue history and concentration-level mix.)
What litigation or regulatory events could affect Omnipaque 210 supply or exclusivity?
Answer: In this category, legal events typically cluster around:
- Generic competition (ANDA litigation pathways)
- Labeling and safety reporting disputes
- Patent or data exclusivity challenges
- Manufacturing compliance actions
No Omnipaque 210-specific litigation timeline is provided in the prompt; producing a legal-impact forecast would require direct docket and patent records.
Key Takeaways
- Omnipaque 210 is a mature iohexol brand in the iodinated contrast media market; current “clinical trial updates” are most often iohexol-class protocol and safety studies rather than Omnipaque-210-only late-stage development.
- Market performance is driven mainly by hospital procurement, tender pricing, and formulary access, with competitive substitution risk from other iodinated contrast agents and generics.
- A quantified Omnipaque 210 market projection (revenue, market share, CAGR, and scenario ranges) cannot be grounded in the information provided.
FAQs
- Are Omnipaque 210 trials registered under “iohexol” rather than “Omnipaque 210”?
- How do renal safety endpoints differ across iodinated contrast trials for iohexol products?
- What imaging protocols most influence contrast volume and iodine dose choices for 210 mgI/mL?
- How do hospital tender cycles typically shift volume among iodinated contrast brands?
- What non-patent factors most affect Omnipaque 210 supply and continuity of supply for health systems?
References
- FDA. “Drug Products at FDA: Orange Book.” US FDA (accessed via Orange Book database).
- ClinicalTrials.gov. “iohexol” and iodinated contrast media study records (accessed via registry search results).
