Last updated: September 24, 2026
OMNIPAQUE 300 is a 300 mg iodine/mL injectable formulation of iohexol, a nonionic, low-osmolar iodinated contrast medium marketed by GE HealthCare. Its commercial position depends on recurring hospital and imaging-center demand, supply reliability, procurement contracts, and the broader growth of computed tomography, angiography, and fluoroscopic procedures.
The product has no meaningful remaining U.S. patent or regulatory exclusivity. Its economic protection comes from brand recognition, manufacturing scale, hospital formulary placement, supply continuity, and the technical burden of producing sterile, high-volume injectable contrast media. GE HealthCare does not separately disclose OMNIPAQUE 300 revenue, making product-level revenue estimates unavailable from public filings.
What is OMNIPAQUE 300 and how is it used?
OMNIPAQUE 300 contains iohexol at an iodine concentration of 300 mg/mL. It is administered intravenously, intra-arterially, intrathecally, and in certain body-cavity procedures, depending on the indication and age group.
The product is used primarily for:
- Contrast-enhanced CT imaging
- CT angiography
- Digital subtraction angiography
- Cerebral and peripheral angiography
- Cardiac angiography and left ventriculography
- Intravenous urography
- Certain pediatric imaging procedures
- Selected intrathecal examinations
The product’s clinical value is linked to its low-osmolar, nonionic profile and broad labeling across diagnostic imaging procedures. The FDA-approved U.S. product is listed under NDA 018956 in FDA Drugs@FDA records.[1]
What does “300” mean in OMNIPAQUE 300?
The number 300 refers to the iodine concentration: 300 mg of organically bound iodine per milliliter of solution. It does not identify a separate active pharmaceutical ingredient.
| Product |
Active ingredient |
Iodine concentration |
| OMNIPAQUE 140 |
Iohexol |
140 mg/mL |
| OMNIPAQUE 180 |
Iohexol |
180 mg/mL |
| OMNIPAQUE 240 |
Iohexol |
240 mg/mL |
| OMNIPAQUE 300 |
Iohexol |
300 mg/mL |
| OMNIPAQUE 350 |
Iohexol |
350 mg/mL |
The 300 mg/mL strength is commercially important because it is suitable for a wide range of CT and angiographic applications while providing greater iodine delivery than lower-concentration formulations.
What is the FDA regulatory status of OMNIPAQUE 300?
OMNIPAQUE 300 is an FDA-approved prescription drug marketed under an established NDA. It is a small-molecule injectable product, not a biologic, and therefore has no biosimilar pathway.
FDA regulatory characteristics include:
| Regulatory issue |
OMNIPAQUE 300 status |
| Active ingredient |
Iohexol |
| Dosage form |
Injectable solution |
| Route |
Intravenous, intra-arterial, intrathecal, and other labeled routes |
| NDA |
018956 |
| Product category |
Prescription contrast medium |
| Biologic status |
Not a biologic |
| Biosimilar pathway |
Not applicable |
| Reference-listed drug |
Yes, subject to FDA listing records |
| Primary manufacturer |
GE HealthCare and affiliated entities |
| Regulatory exclusivity |
Expired |
| Patent exclusivity |
Expired or no longer commercially material |
FDA labeling identifies risks associated with hypersensitivity reactions, kidney injury, extravasation, thyroid effects, and intrathecal administration. Product handling requires sterile manufacturing, validated container systems, and controls for particulate matter, endotoxins, concentration, and fill volume.[2]
When does OMNIPAQUE 300 lose exclusivity?
OMNIPAQUE 300 lost meaningful exclusivity decades ago. Iohexol was approved in the United States in the 1980s, and any original composition-of-matter, formulation, or regulatory exclusivity periods have expired.
There is no current basis to treat OMNIPAQUE 300 as a patent-protected monopoly product. The commercial question is therefore substitution and supply, not patent expiry.
What patents protect OMNIPAQUE 300?
No active U.S. patent is known to provide commercially significant exclusivity for the basic iohexol molecule or the standard OMNIPAQUE 300 injectable formulation. Historical patent protection for iohexol and its use in diagnostic imaging has expired.
Potentially relevant intellectual-property categories include:
- Historical compound patents covering iohexol
- Manufacturing patents for iodinated aromatic compounds
- Process patents for purification and impurity control
- Container and delivery-system patents
- Device patents associated with automated injectors
- Trade secrets covering process yield, sterilization, and quality control
These categories do not generally prevent an approved generic iohexol injection from competing with OMNIPAQUE 300.
What is the Orange Book status of OMNIPAQUE 300?
OMNIPAQUE is associated with an FDA-approved NDA and has historically been listed as a reference product for iohexol injection products. Any Orange Book patent listings that once applied to the product are not expected to create a current market barrier because the foundational exclusivity periods have expired.
The relevant regulatory pathway for a competing iohexol injection is generally an abbreviated new drug application, subject to FDA requirements for pharmaceutical equivalence, bioequivalence where applicable, sterility, stability, labeling, and manufacturing controls.
Because OMNIPAQUE 300 is an injectable contrast medium, generic entry is more technically demanding than entry for a conventional oral tablet. The FDA must assess injectable quality attributes, container closure, particulate controls, endotoxin limits, and manufacturing validation. That technical burden can reduce the number of reliable suppliers even when no patent barrier exists.[3]
How many patents cover OMNIPAQUE 300?
The product has historical patent coverage but no material current patent estate comparable to a recently launched specialty drug.
| Patent category |
Current commercial impact |
| Iohexol compound patents |
Expired |
| Original formulation patents |
Expired |
| Method-of-use patents for imaging |
Expired or nonexclusive |
| Manufacturing-process patents |
Possible, but generally narrow and nonblocking |
| Packaging and injector patents |
May affect specific systems, not the drug broadly |
| Current Orange Book exclusivity |
No meaningful exclusivity expected |
Patent risk is low. Manufacturing and regulatory execution risk is more important.
Which companies compete with OMNIPAQUE 300?
OMNIPAQUE 300 competes in the broader iodinated contrast-media market rather than only against iohexol products. Hospitals often evaluate products by clinical suitability, contract pricing, availability, injector compatibility, and supplier reliability.
Major branded competitors
| Brand |
Active ingredient |
Company |
| OMNIPAQUE |
Iohexol |
GE HealthCare |
| VISIPAQUE |
Iodixanol |
GE HealthCare |
| ISOVUE |
Iopamidol |
Bracco |
| ULTRAVIST |
Iopromide |
Bayer |
| OPTIRAY |
Ioversol |
Guerbet |
| XENETIX |
Iobitridol |
Guerbet |
| Iomeron |
Iomeprol |
Bracco or regional affiliates |
OMNIPAQUE and VISIPAQUE are both associated with GE HealthCare, but they occupy different positions. OMNIPAQUE is a low-osmolar monomer, while VISIPAQUE is an iso-osmolar dimer. ISOVUE, ULTRAVIST, and OPTIRAY are direct therapeutic-category competitors with different active ingredients and commercial histories.
Generic iohexol competition
Generic iohexol injection can compete directly with OMNIPAQUE when it matches the relevant concentration, route, labeling, packaging, and procurement requirements. The most important competitive threat is not a single patent challenger but the availability of multiple approved or distributable sources.
Generic market participation can be constrained by:
- Limited sterile injectable capacity
- Shortages of raw materials and iodine intermediates
- High quality-control costs
- Hospital conversion costs
- Need for dependable national distribution
- Contracting practices that favor large suppliers
- Product-specific compatibility with injectors and imaging protocols
Which companies are challenging OMNIPAQUE 300?
Publicly visible commercial competition primarily comes from generic iohexol manufacturers and alternative iodinated contrast agents. A large Paragraph IV litigation campaign is not associated with the current commercial status of OMNIPAQUE 300.
What is the Paragraph IV risk for OMNIPAQUE 300?
Paragraph IV risk is low as a strategic issue because the core patents protecting iohexol and the original product have expired. A generic applicant does not need to defeat a current foundational patent to enter the U.S. market.
The practical risk is an ANDA approval followed by hospital substitution. For an old injectable product, the more relevant barriers are FDA approval, reliable supply, pricing, and account-level contracting.
What patent litigation affects OMNIPAQUE 300?
No current patent litigation is known to be central to the product’s commercial outlook. Historical disputes involving iodinated contrast agents would have limited relevance unless they concern a specific manufacturing process, delivery device, or newly patented formulation.
The absence of major current litigation materially reduces legal uncertainty but does not eliminate commercial pressure from generic substitution.
What formulations are protected by OMNIPAQUE 300 patents?
The standard OMNIPAQUE 300 solution is not protected by a current formulation patent estate that would block ordinary iohexol injection competition.
Formulation-related know-how can still have commercial value. Relevant technical controls include:
- Iohexol concentration and iodine content
- pH and osmolality
- Impurity profile
- Stability over the labeled shelf life
- Container compatibility
- Sterility and endotoxin limits
- Extractables and leachables
- Protection from particulate contamination
- Fill-volume accuracy
These characteristics support product quality and supply reliability, but they are not equivalent to patent exclusivity.
How strong is the patent estate for OMNIPAQUE 300?
The patent estate is weak from a blocking-rights perspective and moderate from a manufacturing-know-how perspective.
| Factor |
Assessment |
| Composition-of-matter protection |
Expired |
| Formulation protection |
Low |
| Method-of-use protection |
Low |
| Orange Book leverage |
Low |
| Manufacturing complexity |
Moderate to high |
| Supplier qualification burden |
Moderate |
| Brand and contracting power |
Moderate to high |
| Litigation exposure |
Low |
| Generic substitution risk |
Moderate to high |
GE HealthCare’s defensible position is based on operational scale, established regulatory history, global distribution, hospital relationships, and the ability to supply multiple concentrations and contrast products.
What is the financial trajectory of OMNIPAQUE 300?
GE HealthCare does not report revenue, gross margin, volume, or operating profit for OMNIPAQUE 300 separately. The company reports financial performance by business segment rather than by individual drug, concentration, or brand.[4]
OMNIPAQUE is part of GE HealthCare’s Pharmaceutical Diagnostics business, which includes contrast media and related diagnostic products. The segment’s financial performance is influenced by:
- Imaging procedure volumes
- CT and angiography utilization
- Pricing and hospital purchasing contracts
- Product mix between low-osmolar and iso-osmolar agents
- Supply chain costs
- Raw-material availability
- Foreign-exchange movements
- New imaging-system placements
- Production capacity and manufacturing efficiency
Revenue trajectory
The likely trajectory is mature and resilient rather than high-growth:
- Long-term procedure growth supports baseline demand.
- Generic and tender pricing limits unit-price expansion.
- Hospital purchasing groups increase price pressure.
- Product shortages can temporarily shift market share.
- Portfolio breadth allows GE HealthCare to defend accounts with several contrast products.
- OMNIPAQUE 300 revenue is likely stable to modestly growing in volume, with pricing dependent on contract renewals and competitive supply.
The product is economically important as part of a recurring consumables portfolio, but it is unlikely to be a standalone growth driver for GE HealthCare. The company’s public filings emphasize portfolio and segment performance rather than revenue from individual brands.[4]
What is the revenue exposure to generic entry?
Generic entry creates price and volume exposure rather than an abrupt patent cliff. The potential effects are:
| Scenario |
Commercial effect |
| Limited generic supply |
OMNIPAQUE retains substantial share; pricing pressure is modest |
| Several reliable generic suppliers |
Hospital substitution increases; price erosion accelerates |
| Shortage of generic products |
Brand demand remains resilient |
| Large national contracts switch suppliers |
Volume loss can occur quickly in affected accounts |
| Broad multi-product contracting |
GE HealthCare can offset OMNIPAQUE pressure with portfolio products |
Because contrast media are used repeatedly in high-volume imaging workflows, even modest per-vial price reductions can affect annual revenue. The impact depends on procurement contracts and whether hospitals prioritize lowest acquisition cost or supply continuity.
What market dynamics drive OMNIPAQUE 300 demand?
Growth in CT and angiography
Demand is tied to diagnostic procedure volumes. Aging populations, cardiovascular disease, oncology imaging, emergency medicine, and expanded CT capacity support long-term utilization.
Contrast-media shortages
Shortages can produce temporary demand surges for alternative suppliers. The 2022 Shanghai manufacturing disruption affecting iodinated contrast supply demonstrated the vulnerability of the market to concentrated production and logistics dependencies.[5] Shortages also make hospitals more willing to maintain multiple qualified suppliers.
Hospital purchasing consolidation
Large health systems and group purchasing organizations negotiate aggressively. Procurement decisions frequently combine price, allocation guarantees, service, product breadth, and shortage response.
Manufacturing and IP barriers
The relevant barriers are operational:
- Specialized sterile injectable facilities
- High-volume production capability
- Validated sterilization processes
- Raw-material security
- Global regulatory registrations
- Quality systems for injectable products
- Distribution capacity
- Ability to support emergency allocations
These barriers can preserve incumbent share even after patent expiry.
How does OMNIPAQUE 300 compare with VISIPAQUE and other contrast agents?
| Attribute |
OMNIPAQUE 300 |
VISIPAQUE |
ISOVUE |
ULTRAVIST |
OPTIRAY |
| Active ingredient |
Iohexol |
Iodixanol |
Iopamidol |
Iopromide |
Ioversol |
| Osmolality class |
Low-osmolar |
Iso-osmolar |
Low-osmolar |
Low-osmolar |
Low-osmolar |
| Primary company |
GE HealthCare |
GE HealthCare |
Bracco |
Bayer |
Guerbet |
| Key commercial advantage |
Broad labeling and established use |
Iso-osmolar positioning |
Established hospital presence |
Global branded portfolio |
Competitive alternative |
| Patent-driven moat |
Low |
Low for legacy product |
Low for legacy product |
Low for legacy product |
Low for legacy product |
| Main defense |
Scale, contracts, supply |
Clinical positioning and portfolio |
Brand and contracts |
Global distribution |
Pricing and supply |
OMNIPAQUE’s competitive advantage is breadth and familiarity. VISIPAQUE can compete where hospitals or clinicians prioritize iso-osmolar contrast. Other low-osmolar agents compete primarily through price, contracting, availability, and local formulary preference.
What generic launch scenarios exist for OMNIPAQUE 300?
Scenario 1: Incremental generic substitution
One or more generic iohexol suppliers win selected hospital contracts. OMNIPAQUE loses volume gradually, with GE HealthCare retaining accounts that value continuity and portfolio contracting.
Scenario 2: Broad price-led conversion
Multiple reliable suppliers enter, and group purchasing organizations move substantial volume to lower-cost iohexol. OMNIPAQUE experiences material price and volume erosion.
Scenario 3: Supply-constrained generic market
Generic products receive approval but cannot provide dependable supply. OMNIPAQUE maintains a premium based on allocation reliability and established distribution.
Scenario 4: Portfolio defense
GE HealthCare uses OMNIPAQUE, VISIPAQUE, service relationships, injector integration, and contract bundling to retain accounts even when equivalent generic products are available.
The most likely commercial outcome is gradual competitive erosion rather than a single date-driven loss of exclusivity.
What is the geographic coverage of OMNIPAQUE 300?
OMNIPAQUE is marketed internationally under GE HealthCare’s global pharmaceutical diagnostics operations. Regulatory status, approved concentrations, packaging, reimbursement, and competitor composition vary by jurisdiction.
The strongest commercial defenses are typically found in markets where:
- GE HealthCare has direct distribution
- Hospital contracts cover multiple products
- Contrast supply is concentrated
- Regulatory approval history supports procurement confidence
- Imaging networks use standardized protocols and injectors
In price-sensitive markets, tender systems can accelerate substitution. In markets affected by supply instability, established suppliers may retain stronger share.
Key Takeaways
- OMNIPAQUE 300 is a 300 mg iodine/mL iohexol injection marketed by GE HealthCare.
- Its U.S. regulatory foundation is NDA 018956.
- Patent and regulatory exclusivity have expired; no current foundational patent moat is commercially significant.
- Biosimilar risk does not apply because iohexol is a small-molecule drug.
- Generic competition is the primary strategic risk.
- Product-specific revenue is not disclosed by GE HealthCare.
- Financial performance is linked to the Pharmaceutical Diagnostics segment, imaging volumes, contract pricing, and supply reliability.
- Manufacturing complexity, sterile injectable standards, and distribution capacity are more important than patent protection.
- OMNIPAQUE 300 competes with VISIPAQUE, ISOVUE, ULTRAVIST, OPTIRAY, and generic iohexol.
- The likely financial trajectory is mature, recurring, and relatively resilient, with gradual pricing pressure rather than a patent-cliff event.
FAQs
Is OMNIPAQUE 300 still patent protected?
No meaningful foundational patent protection is expected to remain for the standard iohexol molecule or OMNIPAQUE 300 formulation.
Is OMNIPAQUE 300 interchangeable with generic iohexol?
Potentially, if the generic product has the relevant FDA approval, concentration, labeling, packaging, and institutional approval. Hospital substitution remains subject to procurement and clinical protocols.
Is OMNIPAQUE 300 a biologic or eligible for biosimilar competition?
No. OMNIPAQUE 300 is a small-molecule injectable drug. Competition proceeds through generic-drug pathways, not biosimilar approval.
Who manufactures OMNIPAQUE 300?
GE HealthCare manufactures and markets OMNIPAQUE through its Pharmaceutical Diagnostics operations, with production and distribution varying by market.
What is the main investment risk for OMNIPAQUE 300?
The main risk is gradual generic and contract-driven erosion of price and volume. Supply shortages, manufacturing disruptions, and changes in CT procedure volumes can produce additional volatility.
References
-
U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs, NDA 018956, Omnipaque. https://www.accessdata.fda.gov/scripts/cder/daf/
-
U.S. Food and Drug Administration. (2023). Omnipaque (iohexol injection) prescribing information. GE HealthCare.
-
U.S. Food and Drug Administration. (2019). ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin: Guidance for industry. https://www.fda.gov/
-
GE HealthCare Technologies Inc. (2024). Annual report for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission.
-
U.S. Food and Drug Administration. (2022). FDA alerts health care professionals of temporary shortage of iodinated contrast media. https://www.fda.gov/shortages
