Last updated: October 21, 2026
Executive summary: OMNIPAQUE 180 is GE HealthCare’s iohexol injection at 180 mg iodine/mL, used mainly for intrathecal imaging and selected angiographic and CT procedures. Its commercial value is tied to the broader contrast-media franchise rather than a separately reported product line. The product has a mature, largely off-patent profile, so market performance depends on manufacturing reliability, hospital contracts, regulatory supply status, formulation continuity, and competition from other iodinated contrast agents. GE HealthCare does not disclose OMNIPAQUE 180 revenue or product-level margins. The most material financial risks are generic substitution, concentration in institutional purchasing, production interruptions, and the clinical migration toward higher-concentration agents for routine CT.
OMNIPAQUE 180 Market Dynamics, Patent Position, FDA Status, and Financial Trajectory
What is OMNIPAQUE 180 and where is it used?
OMNIPAQUE 180 is iohexol injection containing 180 mg of organically bound iodine per milliliter. GE HealthCare markets OMNIPAQUE in several concentrations, including 140, 180, 240, 300 and 350 mg iodine/mL. The 180 formulation is primarily relevant to neuroradiology and selected angiographic or computed tomography procedures.
The FDA-approved label identifies OMNIPAQUE for intrathecal procedures, including adult myelography and contrast enhancement for computed tomography of the cisterns and ventricles. It is also used in selected pediatric and adult imaging procedures under the product’s broader indication set, subject to concentration-specific labeling and physician choice (U.S. Food and Drug Administration [FDA], 2024).
OMNIPAQUE is a nonionic, water-soluble, low-osmolar contrast medium. Its clinical positioning is based on:
- Established use across radiology departments.
- Compatibility with intrathecal administration when used according to labeling.
- Broad concentration availability.
- Long-standing integration into hospital imaging protocols.
- Brand recognition among radiologists, radiology technicians and hospital pharmacies.
OMNIPAQUE 180 is less exposed to routine high-volume CT demand than OMNIPAQUE 300 or 350. Lower concentrations are more concentrated in specialty imaging, where clinical familiarity and product continuity can carry greater weight than a simple unit-price comparison.
What is the FDA regulatory status of OMNIPAQUE 180?
OMNIPAQUE 180 is an FDA-approved prescription drug marketed under a New Drug Application held by GE HealthCare. The product is regulated as an iodinated contrast agent rather than as a biologic, so biosimilar rules do not apply.
| Regulatory attribute |
OMNIPAQUE 180 |
| Active ingredient |
Iohexol |
| Dosage form |
Injectable solution |
| Iodine concentration |
180 mg/mL |
| Drug class |
Nonionic, low-osmolar iodinated contrast medium |
| Primary manufacturer |
GE HealthCare |
| FDA pathway |
Approved New Drug Application |
| Biosimilar exposure |
None |
| Generic exposure |
Yes, subject to approved iohexol products and market availability |
| Main institutional customers |
Hospitals, imaging centers, outpatient radiology providers |
| Principal administration routes |
Intrathecal and selected intravascular uses, according to labeling |
FDA labeling identifies contraindications and warnings relating to hypersensitivity reactions, acute kidney injury risk, extravasation, thyroid dysfunction, and adverse events associated with intrathecal administration. Product selection remains dependent on procedure type, patient characteristics, concentration, administration route and institutional protocol (FDA, 2024).
What is the patent and exclusivity status of OMNIPAQUE 180?
OMNIPAQUE 180 has a mature patent profile. The core iohexol composition and original product protections have expired, and the product does not depend on an active composition-of-matter exclusivity period.
No current blockbuster-style patent exclusivity is expected to protect the basic OMNIPAQUE 180 formulation. Commercial protection instead comes from manufacturing scale, regulatory approvals, supply reliability, hospital contracts and clinical familiarity.
Does OMNIPAQUE 180 have Orange Book protection?
FDA Orange Book treatment for older contrast-media products is narrower than for newly launched small-molecule therapies. The relevant commercial question is whether a specific approved iohexol product has active patents or exclusivity listed against its NDA. The core OMNIPAQUE 180 product is not generally viewed as protected by a current, commercially meaningful composition patent.
The product’s off-patent status means that generic manufacturers can seek approval through an abbreviated pathway when they can satisfy FDA requirements for pharmaceutical quality, labeling, manufacturing controls and, where applicable, product-specific approval standards.
When does OMNIPAQUE 180 lose exclusivity?
The original exclusivity period has already expired. OMNIPAQUE 180 is therefore exposed to generic competition today. The remaining moat is operational rather than legal:
- Consistent supply of iohexol and finished product.
- Compliance with sterile manufacturing requirements.
- Institutional purchasing relationships.
- Regulatory history and physician familiarity.
- Ability to support multiple concentrations and package sizes.
How many patents cover OMNIPAQUE 180?
The original active-ingredient and formulation patent estate is no longer the central barrier to competition. Any remaining patent relevance would likely relate to later-developed manufacturing processes, packaging, delivery systems, or specific uses rather than the fundamental iohexol molecule.
For investment and licensing analysis, OMNIPAQUE 180 should be treated as a mature, substantially off-patent product. A patent-count approach can overstate its protection because older expired patents may remain visible in historical databases even though they do not block generic entry.
The practical competitive barriers are:
- Sterile injectable manufacturing.
- Iodinated raw-material procurement.
- Validation of filling and packaging operations.
- Regulatory inspection readiness.
- Global supply-chain redundancy.
- Hospital formulary conversion costs.
Which companies compete with OMNIPAQUE 180?
OMNIPAQUE 180 competes in two distinct markets: the iohexol market and the broader iodinated contrast-media market.
Direct iohexol competition
Direct competitors are generic or authorized iohexol products approved for comparable concentrations and administration routes. Their ability to compete depends on commercial availability, package configuration, FDA approval scope, manufacturing capacity and contracting strategy.
Generic iohexol competition can create price pressure, but its impact may be limited when:
- The generic is not consistently available.
- Hospitals prioritize supply continuity.
- The product is purchased through group purchasing organizations.
- The relevant concentration has relatively low volume.
- Switching requires protocol or inventory changes.
Therapeutic and procedural substitutes
OMNIPAQUE 180 also competes with other nonionic iodinated contrast agents, including:
- Iopamidol products.
- Iopromide products.
- Ioversol products.
- Iodixanol products.
- Other concentration-specific contrast formulations.
These products are not interchangeable in every procedure. Clinical protocols, renal-risk considerations, osmolality, viscosity, route of administration and institutional formulary decisions affect substitution.
For intrathecal use, the competitive set is narrower than for routine intravenous CT. This supports greater product persistence for OMNIPAQUE 180 than a simple generic price analysis would imply.
What market dynamics affect OMNIPAQUE 180 demand?
Procedure volumes
Demand is linked to the number of imaging procedures requiring iodinated contrast. Growth in CT, angiography, interventional radiology and neuroradiology supports unit demand. However, OMNIPAQUE 180 does not capture the full growth of the CT contrast market because many routine CT studies use 300 or 350 mg iodine/mL formulations.
Hospital purchasing
Hospitals and integrated delivery networks purchase contrast agents through tenders, direct contracts and group purchasing organizations. Pricing is usually confidential. Contract awards may favor a supplier that can provide several concentrations, multiple vial sizes and dependable allocation during shortages.
Supply reliability
Contrast media manufacturing is sensitive to raw-material availability, sterile fill-finish capacity, transportation and plant concentration. In 2022, GE HealthCare reported supply disruption affecting OMNIPAQUE after a manufacturing issue associated with its Shanghai facility. The FDA listed iohexol and other iodinated contrast agents in shortage-related updates during that period (FDA, 2022).
The event demonstrated that supply continuity can influence market share more rapidly than patent status. Hospitals responded through conservation protocols, alternative-agent use and procedure prioritization. A supplier that restores reliable service can preserve accounts even in a mature product category.
Clinical concentration shift
Higher-concentration products are often preferred for routine CT angiography and examinations requiring strong vascular enhancement. That creates a structural limit on OMNIPAQUE 180 volume growth. The 180 formulation retains relevance in specific procedures but is less likely to be the primary growth engine for the overall OMNIPAQUE franchise.
What is the financial trajectory of OMNIPAQUE 180?
GE HealthCare does not disclose revenue, gross margin, volume, average selling price or operating profit for OMNIPAQUE 180 separately. The product is included within a broader pharmaceutical diagnostics portfolio.
The most relevant financial indicators are therefore:
| Financial driver |
Effect on OMNIPAQUE 180 |
| Procedure volume |
Supports unit demand |
| Generic competition |
Pressures price and account retention |
| Manufacturing utilization |
Influences unit cost and supply economics |
| Raw-material costs |
Can compress margin |
| Hospital contracting |
Reduces realized price but protects volume |
| Product shortages |
Can reduce sales and accelerate substitution |
| Portfolio breadth |
Supports cross-selling across concentrations |
| Regulatory compliance |
Protects continuity and avoids costly disruption |
GE HealthCare’s Pharmaceutical Diagnostics segment includes contrast media and radiopharmaceutical products. Segment-level results provide a directional view but do not isolate OMNIPAQUE 180. The company’s financial disclosures emphasize portfolio revenue, organic growth, margins, supply-chain execution and innovation investment rather than individual legacy formulations (GE HealthCare, 2024a, 2024b).
Revenue outlook
The likely revenue profile for OMNIPAQUE 180 is mature and defensive:
- Low probability of strong price-driven growth.
- Moderate sensitivity to imaging procedure volumes.
- Greater sensitivity to supply reliability than to consumer demand.
- Potential unit stability in specialty procedures.
- Long-term price pressure from generic iohexol and rival contrast agents.
- Limited benefit from new-patient adoption because the product is established.
Revenue can remain durable if GE HealthCare maintains hospital contracts and avoids supply interruptions. Margin performance depends on manufacturing scale and procurement efficiency. The product’s financial value is likely higher as part of a multi-concentration portfolio than as an isolated SKU.
What formulation and manufacturing barriers protect OMNIPAQUE 180?
The main barriers are technical and operational rather than patent-based.
Sterile injectable production
Iohexol injection requires sterile compounding, filling, inspection, packaging and release testing. Manufacturing controls must address:
- Sterility assurance.
- Particulate matter.
- Container closure integrity.
- Concentration accuracy.
- Endotoxin limits.
- Stability over the labeled shelf life.
- Compatibility with the intended administration route.
Raw-material and supply-chain exposure
Contrast-media production depends on specialized iodine-containing intermediates and large-volume sterile manufacturing infrastructure. Disruptions can affect multiple concentrations simultaneously. A supplier with only one major production center faces greater operational risk than a supplier with geographically diversified capacity.
Manufacturing economics
The product is relatively mature, so cost advantages depend on:
- High plant utilization.
- Efficient procurement.
- Automated filling.
- Large institutional contracts.
- Coordinated production across concentrations.
- Low batch-failure and recall rates.
Manufacturing capability can delay effective generic entry even when legal exclusivity has expired.
What litigation and Paragraph IV risks affect OMNIPAQUE 180?
OMNIPAQUE 180 has lower litigation risk than a recently launched specialty medicine because its core patents are expired and the product is mature. The principal legal risks are more likely to involve:
- Generic approval disputes.
- Manufacturing or quality allegations.
- Product-liability claims.
- Contract disputes with hospitals or distributors.
- Patent disputes over later-developed formulations or production methods.
A Paragraph IV challenge would matter only if an applicant sought approval while asserting that a listed patent was invalid, unenforceable or not infringed. The commercial significance of such a challenge is limited if no active patent materially blocks an approved iohexol product.
No biosimilar litigation pathway applies. Iohexol is a chemically synthesized small molecule, not a biologic.
What generic launch scenarios exist for OMNIPAQUE 180?
Scenario 1: Stable branded share
GE HealthCare retains substantial share because hospitals prioritize consistent supply, broad concentration availability and validated protocols. Price erosion remains gradual.
Scenario 2: Accelerated generic substitution
A reliable generic supplier offers competitive pricing, full concentration coverage and dependable allocation. Large hospital systems convert routine purchases, reducing OMNIPAQUE 180 volume and net price.
Scenario 3: Supply-driven share volatility
A manufacturing disruption affects GE HealthCare or a generic competitor. Hospitals temporarily qualify alternatives, and some converted accounts do not return after supply normalizes.
Scenario 4: Specialty-product resilience
Generic competition affects high-volume intravenous products more than OMNIPAQUE 180. Intrathecal and specialty-use demand remains relatively stable because physicians and hospitals place greater value on procedural continuity.
How does OMNIPAQUE 180 compare with other iodinated contrast agents?
| Factor |
OMNIPAQUE 180 |
Higher-concentration iohexol |
Iodixanol products |
Other low-osmolar agents |
| Primary role |
Specialty and intrathecal imaging |
Routine CT and angiography |
Selected renal-risk and specialized protocols |
Broad procedural competition |
| Patent maturity |
Mature, off-patent |
Mature, off-patent |
Mature or late-life portfolio |
Generally mature |
| Generic risk |
High |
High |
Variable by product and market |
High |
| Volume growth |
Limited |
More directly linked to CT growth |
Procedure-specific |
Procedure-specific |
| Main defense |
Clinical familiarity and supply |
Portfolio scale and contracts |
Clinical positioning |
Price and formulary access |
| Key risk |
Niche volume and substitution |
Price erosion and competition |
Premium pricing pressure |
Hospital tender losses |
What is the geographic coverage of OMNIPAQUE 180?
OMNIPAQUE is marketed across major regulated markets, although product names, approved concentrations, package sizes and local marketing authorization holders can differ. The United States is strategically important because of its large imaging market and institutional purchasing structure. Europe and other developed markets add scale but have distinct tender systems, reimbursement arrangements and regulatory requirements.
Geographic performance depends on:
- Local registration status.
- National and regional procurement.
- Reimbursement for imaging procedures.
- Availability of competing contrast agents.
- Manufacturing allocation.
- Local requirements for packaging and labeling.
A disruption at a major production site can have international effects when the same facility supplies multiple markets.
What is the commercial outlook for OMNIPAQUE 180?
OMNIPAQUE 180 is likely to remain a durable but mature product. Its commercial outlook is stronger on continuity than on expansion. The product can generate recurring institutional revenue when GE HealthCare maintains supply, regulatory compliance and portfolio-wide contracting strength.
The central investment thesis is not patent-driven growth. It is a cash-generation and portfolio-retention thesis subject to price erosion and operational risk. Product-level upside is limited, but OMNIPAQUE 180 can support the broader Pharmaceutical Diagnostics business by maintaining customer relationships and filling a complete range of contrast-media requirements.
Key Takeaways
- OMNIPAQUE 180 is iohexol injection at 180 mg iodine/mL.
- Its principal value is in intrathecal and selected specialty imaging applications.
- Core patent exclusivity has expired, and generic competition is the main legal and commercial risk.
- No biosimilar pathway applies.
- GE HealthCare does not report OMNIPAQUE 180 revenue separately.
- Financial performance is best assessed through the Pharmaceutical Diagnostics segment and contrast-media market conditions.
- Hospital contracts, supply continuity and sterile manufacturing capacity are more important than active patent protection.
- Higher-concentration products are better positioned for routine CT growth.
- OMNIPAQUE 180 should be modeled as a mature, recurring-revenue product with price and supply risks.
FAQs about OMNIPAQUE 180 market and financial outlook
Is OMNIPAQUE 180 a generic drug?
OMNIPAQUE 180 is a branded iohexol product. Because iohexol is an established small molecule, approved generic iohexol products can compete where they have the required FDA approvals and commercial supply.
Is OMNIPAQUE 180 still patent protected?
The core iohexol product is mature and substantially off-patent. Any remaining patent activity would be more likely to concern manufacturing, packaging or later-developed use claims than the basic molecule.
Does OMNIPAQUE 180 have biosimilar competition?
No. Biosimilars apply to biological products. OMNIPAQUE 180 contains the chemically synthesized small molecule iohexol.
Why would a hospital continue buying OMNIPAQUE 180 after patent expiry?
Hospitals may retain the product because of validated protocols, physician familiarity, supply reliability, concentration availability, purchasing agreements and the operational cost of qualifying alternatives.
Is OMNIPAQUE 180 a growth product for GE HealthCare?
It is more likely a mature portfolio-retention product than a high-growth product. Its value comes from recurring institutional demand and its contribution to GE HealthCare’s broader contrast-media offering.
References
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GE HealthCare. (2024a). 2024 annual report. https://investor.gehealthcare.com/financial-information/annual-reports-and-proxy-statements
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GE HealthCare. (2024b). Pharmaceutical diagnostics. https://www.gehealthcare.com/products/contrast-media
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U.S. Food and Drug Administration. (2022). FDA drug shortages: Iohexol injection and iodinated contrast media updates. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
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U.S. Food and Drug Administration. (2024). OMNIPAQUE (iohexol injection) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018956s075lbl.pdf
