List of Excipients in Branded Drug OMNIPAQUE

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
GE Healthcare Inc	OMNIPAQUE	iohexol	0407-1401	EDETATE CALCIUM DISODIUM
GE Healthcare Inc	OMNIPAQUE	iohexol	0407-1401	HYDROCHLORIC ACID
GE Healthcare Inc	OMNIPAQUE	iohexol	0407-1401	SODIUM HYDROXIDE
GE Healthcare Inc	OMNIPAQUE	iohexol	0407-1401	TROMETHAMINE
GE Healthcare Inc	OMNIPAQUE	iohexol	0407-1412	EDETATE CALCIUM DISODIUM
GE Healthcare Inc	OMNIPAQUE	iohexol	0407-1412	HYDROCHLORIC ACID

OMNIPAQUE Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: October 5, 2026

OMNIPAQUE is iohexol, a nonionic, low-osmolar iodinated contrast medium marketed by GE HealthCare. Its excipient strategy is deliberately narrow: aqueous formulation, pH control, a chelating agent, and no antimicrobial preservative. The main commercial opportunities are in manufacturing efficiency, ready-to-use presentations, oral and rectal diagnostic applications, packaging, supply continuity, and differentiated hospital workflow rather than in creating a new active pharmaceutical ingredient.

The core competitive risks are generic iohexol injections, hospital purchasing pressure, contrast-media shortages, raw-material availability, and limited room for price differentiation in standard intravascular use. The strongest defensible positions are likely to involve product quality, manufacturing know-how, container compatibility, supply reliability, device integration, and regulatory execution.

What is OMNIPAQUE and how is it formulated?

OMNIPAQUE contains iohexol, a water-soluble, nonionic iodinated contrast agent. It is used for computed tomography, angiography, urography, intrathecal imaging, arthrography, and oral or rectal gastrointestinal imaging, depending on concentration and presentation.

The commercial product is supplied in multiple iodine concentrations, generally ranging from 140 to 350 mg iodine/mL for injectable products. Lower-concentration oral and rectal products are also available in selected markets and may be supplied as ready-to-use solutions or diluted preparations.

What excipients are used in OMNIPAQUE?

Public labeling identifies the principal inactive ingredients as:

Excipient or formulation component	Functional role
Water for injection	Solvent and bulk vehicle
Tromethamine	Buffer and pH-control agent
Edetate calcium disodium	Chelating agent that binds trace metal ions
Hydrochloric acid or sodium hydroxide	pH adjustment
Container and closure system	Product-contact packaging and stability control

OMNIPAQUE is generally described as preservative-free. The formulation does not rely on antimicrobial preservatives because the product is supplied as a sterile, single-use or controlled-use injectable preparation. The absence of preservatives is relevant to tolerability, regulatory positioning, and container selection. [1]

The excipient system is intentionally simple. Iohexol is highly water-soluble, and the principal formulation challenge is not solubilization. It is control of pH, osmolality, purity, particulate burden, sterility, extractables, leachables, and long-term chemical stability.

What is the excipient strategy for OMNIPAQUE?

The strategy has four commercial objectives:

1. Maintain chemical and physical stability in a high-concentration aqueous product.
2. Minimize excipient burden for parenteral administration.
3. Support multiple iodine concentrations without changing the fundamental formulation platform.
4. Permit high-volume, sterile manufacturing and rapid administration in imaging departments.

Why does OMNIPAQUE use a chelating agent?

Edetate calcium disodium can reduce the impact of trace metal ions that may catalyze degradation or affect product quality. In a large-scale aqueous injectable, metal control is important because raw materials, process equipment, water systems, and containers can introduce low levels of metal contaminants.

The chelator also supports batch-to-batch consistency. Its value is operational as much as chemical: it can provide a wider control margin against trace impurities without requiring a more complex excipient system.

Why is tromethamine used?

Tromethamine provides buffering capacity and helps maintain the product within its specified pH range. pH control is relevant to iohexol stability, compatibility with the container system, and patient tolerability.

The buffer concentration must remain low enough to avoid unnecessary excipient exposure while providing adequate stability through manufacturing, storage, transport, and administration.

Why is OMNIPAQUE preservative-free?

A preservative-free sterile formulation avoids exposure to antimicrobial agents that could create compatibility or tolerability issues in intravascular, intrathecal, or other sensitive applications. It also avoids the need to qualify preservative concentration across different dose volumes and administration routes.

The tradeoff is greater reliance on aseptic manufacturing, validated sterilization controls where applicable, container integrity, and disciplined handling after opening.

What formulations are protected by OMNIPAQUE-related intellectual property?

The primary iohexol composition is an established product platform. The commercial value of any remaining intellectual property is more likely to arise from specific presentations, manufacturing processes, packaging systems, quality controls, or use claims than from the basic concept of iohexol in water.

Potentially relevant protection areas include:

Protection area	Commercial relevance
Iohexol manufacturing process	Impurity profile, yield, cycle time, and cost of goods
High-iodine-concentration formulation	Stability, viscosity, osmolality, and injectability
Intrathecal presentations	Sterility, endotoxin control, particulate limits, and route-specific labeling
Oral or rectal products	Palatability, dilution, dosing workflow, and packaging
Container closure system	Extractables, leachables, moisture control, and shelf life
Automated injection compatibility	Syringe, injector, tubing, and device integration
Manufacturing controls	Trace metals, degradation products, bioburden, and particulate control

A complete live patent opinion requires a current jurisdiction-by-jurisdiction search of issued patents, pending applications, terminal disclaimers, assignments, and litigation records. Public product labeling alone cannot establish whether a particular process, presentation, or device claim remains enforceable.

When does OMNIPAQUE lose exclusivity?

The original composition-of-matter exclusivity for iohexol is no longer the principal barrier to competition. Generic and multisource iohexol products have entered the market in several jurisdictions, and the product should be analyzed as a mature contrast-media franchise.

The relevant exclusivity layers are now:

Exclusivity layer	Status and strategic implication
Active ingredient patent	Generally no longer the main barrier
Regulatory exclusivity	Depends on the specific application and jurisdiction
Formulation patents	May apply to narrow compositions or presentations
Method-of-use patents	Potentially relevant to specific imaging procedures
Process patents	Can affect manufacturing economics and impurity control
Trademark and branding	Supports product recognition but does not prevent generic substitution
Supply and quality reputation	Commercially important despite limited legal exclusivity

For U.S. products, FDA approval status and Orange Book records must be checked by application number and presentation. Not every contrast product or diagnostic formulation creates a broad, commercially meaningful Orange Book barrier. Where a product is listed, a challenger may assess Paragraph IV exposure against the listed patent claims. Where no relevant listed patent applies, competition may proceed through other regulatory pathways.

What is the Orange Book status of OMNIPAQUE?

OMNIPAQUE is an FDA-approved prescription diagnostic product. Its relevant U.S. applications include injectable and oral or rectal presentations associated with iohexol labeling.

The Orange Book analysis should distinguish:

• the approved drug application;
• the specific dosage form and route;
• the listed patents, if any;
• patent-use codes;
• whether a proposed generic would be required to make a Paragraph IV certification;
• whether the reference product is eligible for a 30-month stay following patent litigation.

A product-level Orange Book search is necessary because patent listings can differ by application and presentation. A generic injectable iohexol applicant may not face the same patent profile as an applicant targeting an oral or rectal product.

Which companies are challenging OMNIPAQUE?

The relevant competitive field includes generic contrast-media manufacturers, hospital suppliers, radiology-pharmacy distributors, and alternative iodinated contrast products. Competition is not limited to a single generic applicant because hospital contracts often evaluate several products at once.

Potential competitors include manufacturers of:

• generic iohexol;
• iopamidol;
• iopromide;
• ioversol;
• iodixanol;
• diatrizoate products for selected oral or gastrointestinal uses.

The commercial comparison depends on iodine concentration, route, viscosity, osmolality, packaging, injector compatibility, back-order history, and contract pricing. A competitor does not need to reproduce every OMNIPAQUE presentation to exert pricing pressure. A limited portfolio covering high-volume CT concentrations can be sufficient.

What generic entry risks exist for OMNIPAQUE?

Generic entry risk is highest in standard intravenous CT concentrations, where the clinical use is established and purchasing decisions are price-sensitive.

High-risk segments

• 300 and 350 mg iodine/mL injectable products;
• large-volume CT bottles;
• prefilled syringes and bulk packages used in high-throughput imaging;
• hospital tenders and integrated delivery network contracts;
• products with uncomplicated room-temperature storage.

More defensible segments

• intrathecal presentations;
• specialized angiography concentrations;
• oral or rectal products with established workflow advantages;
• validated injector-device combinations;
• presentations supported by reliable shortage performance;
• products with strong global regulatory coverage.

A generic competitor must demonstrate pharmaceutical equivalence, sterility, stability, container compatibility, and route-specific safety. For injectable contrast products, manufacturing execution can be a greater practical barrier than the basic formulation.

What manufacturing and IP barriers affect generic iohexol?

The main barriers are technical and operational.

Iohexol synthesis and impurity control

Iohexol is a heavily iodinated, polyhydroxylated molecule. Commercial manufacturing requires control of reaction completeness, regioisomeric or process-related impurities, residual solvents, trace metals, and degradation products. The impurity profile must remain within regulatory specifications at commercial scale.

High-concentration aqueous processing

High-iodine solutions can create elevated viscosity and impose demands on mixing, filtration, filling, pumping, and injection equipment. The product must remain homogeneous across the shelf life and through temperature excursions.

Sterile manufacturing

Parenteral contrast products require robust controls for bioburden, endotoxins, visible and subvisible particles, container closure integrity, and aseptic processing. A defect rate that is manageable in an oral product can be unacceptable in an injectable product.

Container compatibility

Plastic bottles, glass vials, syringes, elastomeric closures, and transfer sets can interact differently with the formulation. Extractables and leachables, adsorption, permeability, and breakage risk can influence the selection of packaging.

These barriers can support process patents, trade secrets, regulatory know-how, and customer switching costs even when composition patents have expired.

What commercial opportunities exist in OMNIPAQUE excipients?

The most credible opportunities are incremental and platform-based.

1. Excipient and raw-material supply

Suppliers can target pharmaceutical-grade tromethamine, edetate calcium disodium, high-purity water systems, and specialized packaging materials. The opportunity is strongest where a supplier can provide validated quality, dual sourcing, low metal contamination, and stable global supply.

2. Ready-to-use oral and rectal products

Oral and rectal imaging products can benefit from improved dosing convenience, lower preparation time, better packaging ergonomics, and neutral or improved palatability. Flavor systems must be evaluated carefully because they can affect stability, microbial control, labeling, and patient acceptance.

3. Container and delivery systems

Commercial value can be created through:

• prefilled syringes;
• injector-compatible containers;
• lower-waste bottle designs;
• tamper-evident closures;
• barcode-enabled packaging;
• dose tracking and inventory systems;
• reduced-dead-volume connectors.

The intellectual-property opportunity is more likely to sit in the package, device, or workflow system than in a replacement excipient.

4. Stability-enhancing process controls

A manufacturer may gain an advantage through low-metal water systems, improved equipment passivation, optimized chelator levels, tighter oxygen control, or better container closure performance. These measures may reduce degradation and extend usable shelf life.

5. Shortage-resilient supply

Contrast-media shortages have demonstrated the commercial value of manufacturing redundancy and inventory visibility. A supplier that can provide validated alternate sites, regional stock, and reliable delivery may win hospital contracts despite limited formulation differentiation.

How does OMNIPAQUE compare with competing contrast agents?

Product	Active ingredient	General commercial position
OMNIPAQUE	Iohexol	Broad route and concentration portfolio; established nonionic low-osmolar product
ISOVUE	Iopamidol	Major competing nonionic low-osmolar agent
ULTRAVIST	Iopromide	Competes in CT and angiographic applications
OPTIRAY	Ioversol	Competes in high-volume diagnostic imaging
VISIPAQUE	Iodixanol	Iso-osmolar positioning with different cost and formulation profile
Gastrografin	Diatrizoate salts	Ionic, high-osmolar gastrointestinal diagnostic use

The most direct comparisons are among iohexol, iopamidol, iopromide, and ioversol. The excipient differences are less important to purchasers than total delivered cost, injector compatibility, supply reliability, clinical familiarity, and contract terms.

Iodixanol can compete through iso-osmolar positioning, while diatrizoate products occupy a different gastrointestinal-use segment. The competitive set therefore depends on route and procedure rather than active ingredient alone.

What patent litigation and Paragraph IV risks affect OMNIPAQUE?

The principal litigation risk for a mature product is likely to concern a narrow formulation, process, device, or method claim rather than the basic iohexol molecule.

A Paragraph IV case would require a generic applicant to certify that a listed patent is invalid, unenforceable, or not infringed. If the reference application has a relevant listed patent and the sponsor sues within the statutory period, FDA approval may be subject to a 30-month stay under the Hatch-Waxman framework. [2]

For OMNIPAQUE, diligence should focus on:

• current Orange Book listings by application;
• patent-use codes;
• generic approval histories;
• ANDA litigation involving iohexol;
• settlements that include launch dates or licenses;
• patent assignments involving GE HealthCare or related entities;
• patents covering syringes, injectors, or specific contrast-media uses.

No commercial conclusion should be based solely on the existence of a patent family. Claim scope, remaining term, enforceability, regulatory relevance, and the target generic presentation determine the actual entry risk.

What is the FDA regulatory status of OMNIPAQUE?

OMNIPAQUE is FDA-approved as an iodinated contrast agent for multiple diagnostic indications and routes. FDA labeling specifies concentration, route, dosing, warnings, contraindications, preparation requirements, and storage conditions. [1]

The regulatory opportunity for a competing excipient strategy is limited by the need to preserve the approved product's critical quality attributes. A modified formulation may require a new drug application, supplement, or other regulatory pathway depending on the extent of the change and the product's regulatory classification.

Changes to tromethamine, edetate calcium disodium, pH, packaging, flavor, or preservative status could affect:

• stability;
• osmolality;
• viscosity;
• particulate formation;
• compatibility with injectors;
• toxicology;
• extractables and leachables;
• route-specific safety;
• comparative bioequivalence or pharmaceutical equivalence.

What is the revenue exposure for OMNIPAQUE?

OMNIPAQUE is exposed to mature-product pricing pressure, but its revenue base can remain resilient because contrast agents are required for high-volume imaging procedures. Revenue is driven by procedure volume, hospital contracts, product availability, concentration mix, regional reimbursement, and supply performance.

The highest revenue exposure is generally associated with:

• routine CT imaging;
• large-volume institutional contracts;
• high-use 300 and 350 mg iodine/mL products;
• global radiology networks;
• prefilled or automated-injection formats.

A price reduction in standard injectable products can have a larger financial effect than a price change in lower-volume oral or intrathecal presentations. Conversely, supply disruptions can shift purchasing rapidly to alternative products.

Key Takeaways

• OMNIPAQUE is iohexol, a mature nonionic low-osmolar iodinated contrast product.
• Its excipient system is simple and generally includes water for injection, tromethamine, and edetate calcium disodium, with acid or base for pH adjustment.
• The product is generally preservative-free, increasing dependence on sterile manufacturing and container integrity.
• The basic iohexol molecule is no longer the main exclusivity barrier. Commercial defenses are more likely to involve manufacturing, packaging, process control, supply reliability, and device integration.
• Generic risk is highest for standard high-volume intravenous CT concentrations.
• The strongest excipient-related opportunities are in validated raw-material supply, ready-to-use oral products, container systems, injector compatibility, and stability controls.
• A current Orange Book, patent, litigation, and settlement review is required before making a launch, licensing, or freedom-to-operate decision.

FAQs About OMNIPAQUE Excipient and Commercial Strategy

Does OMNIPAQUE contain a preservative?

OMNIPAQUE injectable products are generally labeled as preservative-free. The product relies on sterile manufacturing, container closure integrity, and controlled handling.

What is the main chelating excipient in OMNIPAQUE?

The principal chelating agent identified in public labeling is edetate calcium disodium.

Can a generic company change the excipients in iohexol injection?

A generic company may use a different formulation only if it satisfies applicable FDA requirements for pharmaceutical equivalence, safety, stability, quality, and route-specific performance. A material excipient change can increase regulatory requirements.

Is OMNIPAQUE an iso-osmolar contrast agent?

No. OMNIPAQUE is generally classified as a nonionic low-osmolar contrast medium. Iodixanol products such as VISIPAQUE occupy the iso-osmolar segment.

What is the best licensing opportunity around OMNIPAQUE?

The strongest opportunities are likely to involve delivery systems, prefilled formats, injector compatibility, shortage-resilient manufacturing, packaging technology, and specialized oral or rectal presentations rather than a new basic iohexol composition.

References

1. DailyMed. (n.d.). OMNIPAQUE- iohexol injection, solution; OMNIPAQUE- iohexol solution. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application process. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda

4. GE HealthCare. (2024). Annual report. GE HealthCare Technologies Inc. https://investor.gehealthcare.com/

5. United States Pharmacopeia. (n.d.). General chapter <797>: Pharmaceutical compounding - sterile preparations. United States Pharmacopeial Convention.