Last updated: August 22, 2026
OMNIPAQUE 240 is iohexol injection containing 240 mg of organically bound iodine per mL. GE HealthCare markets it as a nonionic, low-osmolar contrast medium for intravascular, intrathecal, and body-cavity imaging procedures. Its core U.S. regulatory exclusivity and composition-of-matter patent protection have expired. The product remains commercially relevant because of recurring imaging demand, hospital purchasing contracts, established workflow integration, and the broader value of GE HealthCare's contrast-media portfolio.
Standalone revenue for OMNIPAQUE 240 is not disclosed. GE HealthCare reports contrast media within its Imaging segment rather than as a separate product line. The financial trajectory is therefore best assessed through segment performance, procedure volumes, product mix, generic competition, supply reliability, and the strategic value of contrast media to GE HealthCare's imaging equipment business.
What is OMNIPAQUE 240 and how is it used?
OMNIPAQUE 240 is an injectable iohexol formulation with an iodine concentration of 240 mg/mL. It is used as an X-ray and computed tomography contrast agent, including for selected angiographic, urographic, CT, and intrathecal procedures. The product is administered by healthcare professionals and is not a retail prescription medicine.
The 240 mg/mL concentration occupies a lower iodine-concentration position than OMNIPAQUE 300 and OMNIPAQUE 350. Product selection depends on the imaging protocol, anatomical target, route of administration, patient characteristics, and institutional preference.
| Product attribute |
OMNIPAQUE 240 |
| Active ingredient |
Iohexol |
| Iodine concentration |
240 mg/mL |
| Dosage form |
Sterile injectable solution |
| Therapeutic category |
Iodinated X-ray and CT contrast media |
| U.S. sponsor |
GE HealthCare |
| Regulatory pathway |
New Drug Application |
| U.S. NDA |
18-956 |
| Primary market |
Hospitals, imaging centers, radiology departments |
| Patent status |
Core product protection expired |
| Biosimilar relevance |
None; iohexol is a small-molecule drug |
| Main competitive risk |
Generic iohexol and competing iodinated contrast agents |
FDA labeling identifies iohexol as a nonionic, water-soluble contrast medium used for multiple diagnostic imaging applications. The label also includes warnings concerning hypersensitivity reactions, acute kidney injury risk, extravasation, thyroid effects, and other procedure-related risks.[1]
What is the FDA and Orange Book status of OMNIPAQUE 240?
OMNIPAQUE 240 is an FDA-approved drug product under GE HealthCare's NDA 18-956. FDA approval created the initial regulatory basis for commercial distribution, but the product no longer benefits from new-drug market exclusivity.
The Orange Book framework is significant because generic applicants may rely on the reference-listed drug through an abbreviated new drug application. A generic applicant can challenge listed patents through a Paragraph IV certification if relevant patents remain listed and are asserted to block approval. For an established iohexol injection such as OMNIPAQUE 240, the primary market issue is abbreviated approval and commercial substitution rather than unresolved regulatory exclusivity.
Has OMNIPAQUE 240 lost market exclusivity?
Yes. The product's original regulatory exclusivity period has expired, and iohexol injection is an established generic-eligible product. The commercial franchise is protected mainly by brand recognition, manufacturing capacity, hospital contracts, supply performance, and product breadth.
OMNIPAQUE 240 does not have biologic exclusivity. Biosimilar provisions under the Public Health Service Act do not apply because iohexol is a chemically defined small molecule.
What patents protect OMNIPAQUE 240?
The original composition-of-matter and product-development patent estate for iohexol is expired or commercially exhausted in the United States. No current patent protection comparable to a live composition patent should be assumed to block generic iohexol injection.
Patent risk can still arise from narrower rights covering:
- Specific contrast-media formulations
- Container and packaging configurations
- Automated injector systems
- Delivery protocols
- Imaging methods
- Manufacturing processes
- Stability, sterilization, or filling technology
Those rights would not necessarily prevent approval or sale of a standard iohexol injection. They may affect particular presentations, device combinations, or manufacturing approaches.
What formulation patents protect OMNIPAQUE 240?
The principal commercial product is a formulation of iohexol in an aqueous injectable solution. A generic competitor generally must demonstrate pharmaceutical equivalence and bioequivalence or otherwise satisfy FDA requirements for injectable products. Formulation differences may matter if they affect inactive ingredients, concentration, stability, container closure, or administration instructions.
For OMNIPAQUE 240, formulation patents are less likely to create durable exclusivity than they would for a complex drug-delivery product. Manufacturing controls and regulatory compliance remain practical barriers even when patent barriers are weak.
Are there method-of-use patents for OMNIPAQUE 240?
Iohexol's broad diagnostic uses are established and do not provide a meaningful new-product exclusivity period. Narrow method patents could cover specific imaging procedures or administration protocols, but they would have limited value against a generic used for noninfringing indications or marketed with appropriate labeling restrictions.
Which companies challenge OMNIPAQUE 240 in the market?
The relevant competitors fall into two groups: generic iohexol suppliers and branded alternative contrast-media manufacturers.
Generic iohexol competition
Generic competition can target the same active ingredient and concentration. Hospital buyers typically evaluate:
- FDA approval status
- Dose availability
- Vial and bottle sizes
- Contract pricing
- Supply reliability
- Pharmacy and radiology workflow compatibility
- Shortage history
- Injector-system compatibility
A generic entrant does not need to displace GE HealthCare across the entire imaging department. It can win business through a hospital system contract, a group purchasing organization, or a limited set of high-volume concentrations.
Branded contrast-media competitors
GE HealthCare competes with companies including Bracco and Bayer in the global contrast-media market. Their portfolios include other nonionic iodinated agents, such as iopamidol, iopromide, and ioversol, depending on geography and indication.
The competitive decision is often made at the portfolio level. A hospital may source multiple concentrations and agents from one supplier to simplify procurement, training, injector integration, inventory management, and adverse-event protocols.
| Competitive factor |
OMNIPAQUE 240 position |
| Active ingredient |
Established iohexol profile |
| Patent barrier |
Low |
| Regulatory familiarity |
High |
| Generic substitution risk |
High |
| Hospital switching cost |
Moderate |
| Product-line breadth |
Strong through GE HealthCare portfolio |
| Equipment relationship |
Advantage where GE imaging and injectors are installed |
| Price leverage |
Constrained by tendering and group purchasing |
| Supply-chain value |
High during industry shortages |
What is the financial trajectory of OMNIPAQUE 240?
GE HealthCare does not report OMNIPAQUE 240 revenue, gross margin, volume, or customer concentration separately. Its financial contribution is included within the Imaging segment and the broader pharmaceutical diagnostics and contrast-media activities.
GE HealthCare's Imaging segment generates revenue from imaging systems, service, digital solutions, and related products. Contrast media is strategically important because it generates recurring consumable revenue tied to installed imaging equipment and procedure volumes. The economics differ from capital equipment:
- Contrast media produces repeat purchases.
- Demand tracks CT, angiography, and other imaging activity.
- Purchasing is exposed to hospital budgets and tender pricing.
- Manufacturing and logistics are critical because supply interruptions can affect clinical operations.
- Product profitability is affected by raw-material costs, energy, freight, packaging, and manufacturing utilization.
The financial trajectory for OMNIPAQUE 240 is therefore likely mature rather than high-growth. Revenue growth depends more on procedure expansion, geographic penetration, price realization, and portfolio retention than on new indications or patent-protected pricing.
How does GE HealthCare's Imaging segment affect OMNIPAQUE 240?
GE HealthCare reported approximately $19.6 billion in total revenue for 2024, with Imaging as one of its principal operating segments.[2] The company does not separately identify sales of OMNIPAQUE 240 or total iohexol revenue.
The product benefits from GE HealthCare's installed base in imaging equipment, injector relationships, sales force, distribution network, and hospital contracting infrastructure. These advantages can preserve share after patent expiry, but they do not eliminate generic pricing pressure.
A contrast agent also has strategic value beyond its direct product margin. It can strengthen relationships with radiology departments and support a broader imaging-technology sale. This creates a commercial linkage between contrast media, injectors, CT systems, and service agreements.
What generic entry risks exist for OMNIPAQUE 240?
Generic entry risk is high because the active ingredient is established, the dosage form is conventional, and core exclusivity has expired. The main scenarios are:
Gradual price erosion
One or more generic suppliers enter without immediately replacing the branded product. GE HealthCare retains share through contracts and supply reliability but accepts lower net pricing.
Concentration-specific substitution
Hospitals shift selected volumes of 240 mg/mL iohexol to generic suppliers while continuing to purchase higher concentrations or other products from GE HealthCare.
Portfolio displacement
A hospital system awards a broad contrast-media contract to a competitor. OMNIPAQUE 240 loses volume as part of a larger procurement decision rather than through product-level clinical substitution.
Supply-driven share changes
Shortages or manufacturing interruptions can cause temporary switching. Once a radiology department validates an alternative product, some converted volume may not return.
Limited branded premium
GE HealthCare may preserve a premium where customers value supply assurance, broad concentration availability, injector integration, documentation, and service support. That premium is likely narrower than during the product's protected period.
What patent litigation and Paragraph IV activity affect OMNIPAQUE 240?
No major ongoing patent-litigation event is required to explain the current competitive position of OMNIPAQUE 240. The product is an off-patent, generic-eligible injectable.
Paragraph IV litigation would matter only if a generic applicant challenged an unexpired listed patent associated with the reference product. For a mature iohexol formulation, regulatory approval, manufacturing economics, contracting, and supply execution are more important than a conventional patent cliff.
Potential litigation could still arise over:
- Orange Book patent listing disputes
- Generic labeling or carve-out issues
- Trade dress or trademark rights
- Manufacturing patents
- Device and injector integration
- Contracting or supply arrangements
These issues should not be confused with protection of the underlying iohexol molecule.
How strong is the OMNIPAQUE 240 commercial and IP estate?
The intellectual-property estate is weak as a standalone barrier but the commercial estate remains meaningful.
| Estate component |
Assessment |
| Composition patent |
Expired |
| Regulatory exclusivity |
Expired |
| Biosimilar protection |
Not applicable |
| Generic eligibility |
High |
| Brand recognition |
Strong |
| Hospital contracting |
Important |
| Manufacturing complexity |
Moderate to high |
| Distribution capability |
Strong |
| Installed-base relationships |
Valuable |
| Long-term pricing power |
Limited |
| Standalone growth outlook |
Mature |
The product's strongest defenses are operational. Sterile manufacturing, validated quality systems, demand forecasting, global distribution, and supply continuity can matter more than patents in this market.
What geographic markets drive OMNIPAQUE 240 demand?
Demand is concentrated in markets with high CT and angiography utilization, established hospital infrastructure, and reimbursement for diagnostic imaging. The United States is strategically important because of procedure volume and hospital purchasing scale. Europe and Asia-Pacific add volume but differ in tendering, reimbursement, regulatory requirements, and local competition.
Geographic performance can diverge for three reasons:
- Public procurement can intensify price competition.
- Generic penetration varies by country.
- Contrast-media shortages can alter supplier share rapidly.
The product's global value is therefore portfolio-dependent. GE HealthCare can use a broad range of contrast agents, concentrations, packaging formats, and related equipment to offset weakness in one market.
What is the outlook for OMNIPAQUE 240 revenue?
The base case is stable-to-declining unit economics with resilient demand. Procedure growth and recurring consumption support volume, while generic competition and hospital purchasing pressure constrain price.
The principal upside drivers are higher imaging volumes, increased contrast-enhanced CT utilization, stronger distribution in emerging markets, and supply disruptions affecting competitors. Downside drivers include aggressive generic tendering, hospital consolidation, substitution to competing agents, manufacturing outages, and reduced imaging utilization.
OMNIPAQUE 240 is unlikely to produce a new patent-led revenue surge. Its value is that of a mature, recurring-use diagnostic product embedded in a larger imaging ecosystem.
Key Takeaways
- OMNIPAQUE 240 is iohexol injection at 240 mg iodine/mL, marketed by GE HealthCare.
- Its core patent and regulatory exclusivity protections have expired.
- The product is generic-eligible and faces high substitution risk.
- No biosimilar pathway applies because iohexol is a small-molecule drug.
- GE HealthCare does not disclose OMNIPAQUE 240 revenue separately.
- Financial performance is tied to imaging procedure volumes, hospital contracts, portfolio breadth, and supply reliability.
- The strongest remaining barriers are manufacturing, quality, distribution, and customer relationships rather than patents.
- Generic entry is most likely to cause price erosion, concentration-specific substitution, and contract-driven share loss.
- The product remains commercially useful but has a mature, defensively managed revenue profile.
FAQs About OMNIPAQUE 240
Is OMNIPAQUE 240 the same as iohexol 240?
Yes. OMNIPAQUE 240 is a branded iohexol injection containing 240 mg of iodine per mL. Generic products may use the name "iohexol injection" rather than OMNIPAQUE.
Can hospitals substitute generic iohexol for OMNIPAQUE 240?
Potentially. Substitution depends on FDA approval, concentration, presentation, institutional protocols, purchasing contracts, pharmacy policy, and compatibility with the imaging workflow.
Does OMNIPAQUE 240 have a new patent for its 240 mg/mL concentration?
The mature product should not be treated as protected by an active composition patent. Narrow patents relating to formulations, packaging, manufacturing, or delivery systems require separate claim-level analysis.
Is OMNIPAQUE 240 used in MRI?
No. OMNIPAQUE 240 is an iodinated X-ray and CT contrast agent. MRI contrast agents are generally gadolinium-based products with different active ingredients and regulatory profiles.
What would most improve GE HealthCare's OMNIPAQUE 240 economics?
Higher procedure volumes, reliable supply, favorable hospital contracts, portfolio bundling, and efficient sterile manufacturing would have more impact than patent extension because the core product is off-patent.
References
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U.S. Food and Drug Administration. (2023). OMNIPAQUE (iohexol injection) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018956s099lbl.pdf
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GE HealthCare Technologies Inc. (2025). Annual report for the fiscal year ended December 31, 2024. U.S. Securities and Exchange Commission. https://www.sec.gov/ixviewer/documents/2024-ge-healthcare-annual-report.htm
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U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
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GE HealthCare Technologies Inc. (2024). Annual report for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission. https://www.sec.gov/ixviewer/documents/2023-ge-healthcare-annual-report.htm
