Last updated: September 19, 2026
OMNIPAQUE 70 is generally used to describe a 70 mL presentation of Omnipaque, the iohexol-based iodinated contrast medium marketed by GE HealthCare. It is a mature, off-patent diagnostic product rather than a separately protected active-ingredient brand. Its commercial trajectory depends on imaging procedure volumes, hospital purchasing contracts, generic iohexol competition, manufacturing reliability, and contrast-media supply conditions. GE HealthCare does not report Omnipaque 70 revenue separately, so product-specific sales and margins cannot be calculated from public filings.
What is OMNIPAQUE 70 and who markets it?
Omnipaque is a nonionic, low-osmolar iodinated contrast medium containing iohexol. It is used in computed tomography, angiography, urography, digital subtraction angiography, and other radiographic procedures. U.S. labeling covers multiple iodine concentrations and container sizes, including 70 mL presentations in certain configurations.[1]
| Attribute |
OMNIPAQUE 70 profile |
| Active ingredient |
Iohexol |
| Product class |
Nonionic, low-osmolar iodinated contrast medium |
| Typical reference |
70 mL container or presentation, rather than a distinct active strength |
| Primary manufacturer |
GE HealthCare |
| U.S. regulatory sponsor |
GE Healthcare Inc. |
| U.S. NDA |
018956 |
| Principal customers |
Hospitals, outpatient imaging centers, radiology groups, distributors |
| Main competitors |
Generic iohexol, GE HealthCare’s other Omnipaque presentations, iodixanol, iopamidol, iopromide and ioversol |
| Commercial status |
Mature marketed product |
| Product-specific revenue disclosure |
Not provided by GE HealthCare |
The designation “OMNIPAQUE 70” should not be confused with a 70 mg iodine/mL formulation. In the U.S. market, Omnipaque products are generally identified by iodine concentration, such as 140, 180, 240, 300, and 350 mg iodine/mL, combined with package size. A 70 mL package is commonly associated with a higher-concentration injectable presentation.[1]
What is the FDA regulatory status of OMNIPAQUE 70?
Omnipaque is FDA-approved under NDA 018956. The FDA label identifies iohexol injection as a prescription diagnostic agent and describes its indications, dosage, administration, warnings, and adverse reactions.[1]
The product is not a new chemical entity and does not have current new-drug exclusivity that would prevent abbreviated new drug applications. FDA approval for competing iohexol products can proceed through the ANDA pathway if the applicant demonstrates pharmaceutical equivalence, bioequivalence where applicable, and compliance with manufacturing requirements.
Does OMNIPAQUE 70 have Orange Book exclusivity?
Omnipaque’s commercial protection is not based on active FDA exclusivity. The relevant NDA is longstanding, and the principal commercial barriers are manufacturing, regulatory compliance, hospital contracts, and supply-chain execution.
The FDA Orange Book is the controlling source for current listed patents, exclusivity codes, and reference-product information. Omnipaque’s market position does not resemble that of a recently approved specialty drug with live composition-of-matter or regulatory-exclusivity protection.[2]
| Protection category |
OMNIPAQUE 70 position |
| New chemical entity exclusivity |
Expired |
| Orphan-drug exclusivity |
Not applicable |
| Pediatric exclusivity |
No current material protection identified |
| Composition-of-matter patent |
Expired or commercially immaterial |
| Formulation patent |
No known current barrier to generic iohexol supply |
| Method-of-use patent |
No known current barrier covering routine diagnostic use |
| Orange Book leverage |
Limited |
| Current moat |
Manufacturing scale, quality systems, distribution, contracts and brand familiarity |
When does OMNIPAQUE 70 lose exclusivity?
Omnipaque lost practical market exclusivity years ago. Iohexol was first approved in the 1980s, and the relevant patent and regulatory-exclusivity periods have expired. The product therefore has no meaningful future “loss of exclusivity” event comparable to a branded small-molecule drug approaching patent expiry.
The commercial question is instead how quickly generic substitution and contracting pressure reduce branded share.
Are there Paragraph IV challenges to OMNIPAQUE 70?
Paragraph IV litigation is unlikely to be a central current risk for Omnipaque. Paragraph IV certifications are most consequential when an applicant challenges an unexpired Orange Book-listed patent. A mature iohexol product with no material live patent estate does not create the same litigation incentive.
Generic applicants may use other certification pathways depending on the Orange Book record and the specific ANDA. The absence of major public Paragraph IV litigation does not imply absence of generic competition. It indicates that the competitive contest is primarily commercial and regulatory rather than patent-driven.
What patents protect OMNIPAQUE 70?
No active patent category appears to provide a durable barrier around the core Omnipaque product in the U.S. market.
Composition patents
Iohexol is an established contrast agent. Any original composition-of-matter protection has expired. A new patent cannot ordinarily restore exclusivity to the old active ingredient merely by claiming the same molecule.
Formulation patents
A formulation patent could cover a specific concentration, excipient system, container, or stability profile. Such rights would need to claim a technically distinctive formulation and remain enforceable. Standard iohexol injectable presentations do not appear to have a publicly material, current formulation patent moat.
Method-of-use patents
Omnipaque’s approved uses are established diagnostic procedures. Method-of-use rights covering routine CT, angiography, urography, or related imaging would face limited commercial value if they cannot prevent administration of competing iohexol or other contrast agents.
Manufacturing and process protection
Manufacturing know-how is more relevant than patents. Iodinated contrast agents require control of impurity profiles, iodine content, sterility, particulate matter, osmolality, viscosity, container compatibility, and supply-chain quality. These requirements can delay or limit new entrants even where no enforceable patent blocks approval.
How strong is the patent estate for OMNIPAQUE 70?
The patent estate is weak as a barrier to generic entry but the manufacturing and regulatory estate is stronger.
| Risk or protection |
Assessment |
Commercial effect |
| Core molecule patent |
Low |
Does not restrict generic iohexol |
| Current FDA exclusivity |
Low |
Does not delay ANDA approval |
| Formulation patent |
Low based on public product profile |
Limited protection |
| Device or container patent |
Low to moderate |
May affect specific packaging, not the molecule |
| Manufacturing know-how |
Moderate |
Can raise entry and quality-control costs |
| Sterile manufacturing capacity |
Moderate to high |
Can constrain supply during disruptions |
| Hospital contracting |
Moderate |
Can preserve share despite generic availability |
| Brand recognition |
Moderate |
Supports physician and purchaser familiarity |
What is the competitive landscape for OMNIPAQUE 70?
Omnipaque competes in a broad iodinated contrast-media market rather than a narrow branded-drug market. The principal competitive dimensions are price, supply continuity, concentration availability, compatibility with imaging protocols, safety profile, purchasing agreements, and distributor service.
| Competitor category |
Examples |
Competitive relationship |
| Generic iohexol |
Multiple ANDA-approved or internationally approved suppliers |
Direct substitution |
| Iodixanol |
Visipaque and generic equivalents in some markets |
Lower-osmolar alternative, often higher priced |
| Iopamidol |
Isovue and equivalents |
Alternative nonionic contrast medium |
| Iopromide |
Ultravist and equivalents |
Alternative nonionic contrast medium |
| Ioversol |
Optiray and equivalents |
Alternative nonionic contrast medium |
| Other contrast agents |
Region-specific products |
Compete through price, supply and protocol preference |
Omnipaque can retain commercial share because radiology departments value consistent availability, validated protocols, and predictable performance. Those advantages are weaker in tenders where products are treated as interchangeable and price is the dominant variable.
What market dynamics drive OMNIPAQUE 70 sales?
Imaging procedure volumes
Demand follows CT, angiography, interventional radiology, urology, and other procedures requiring iodinated contrast. Growth in outpatient imaging and aging-related diagnostic demand supports volume. Budget controls and efforts to reduce unnecessary imaging constrain growth.
Generic price competition
Generic iohexol places direct pressure on net prices. Hospitals and group purchasing organizations can negotiate across multiple suppliers, shifting volume to the lowest reliable bidder.
Supply shortages
Contrast-media markets are exposed to manufacturing interruptions because sterile production is concentrated among a limited number of suppliers. The 2022 shutdown of GE HealthCare’s Shanghai contrast-media plant disrupted global supply and caused hospitals to ration or substitute contrast agents.[3] Such events can temporarily increase demand for available Omnipaque inventory, followed by normalization once competitors restore supply.
Product mix
Revenue depends on concentration and package mix. Large-volume containers used in high-throughput CT departments may have different pricing and margin profiles from smaller containers used in outpatient or interventional settings. A 70 mL presentation is therefore influenced by procedure mix and packaging demand, not only by total imaging volume.
Procurement concentration
Hospitals often purchase contrast media through group purchasing organizations, integrated delivery networks, or regional tenders. Contract renewals can move substantial volume between brands without any change in clinical approval status.
What is the financial trajectory for OMNIPAQUE 70?
GE HealthCare reports Omnipaque within its Pharmaceutical Diagnostics business and does not disclose revenue, gross margin, or unit volume for the 70 mL presentation. The company’s public financial statements therefore support segment-level analysis, not product-level valuation.[4]
The likely financial trajectory is mature and volume-sensitive:
| Period |
Expected commercial condition |
| Historical launch period |
Protected branded product with premium pricing |
| Post-exclusivity period |
Generic entry and declining price leverage |
| Current mature period |
Stable procedure-linked demand with tender pressure |
| Supply-disruption periods |
Temporary volume and pricing volatility |
| Long-term base case |
Low-to-moderate nominal growth, with margin pressure |
Revenue exposure
Omnipaque is strategically important to GE HealthCare’s Pharmaceutical Diagnostics business, but the company does not identify Omnipaque 70 as a separate revenue line. Any estimate of product revenue based on the broader segment would be speculative.
The most defensible financial indicators are:
- Radiology procedure growth
- Share of GE HealthCare contrast-media contracts
- Generic iohexol pricing
- Manufacturing utilization
- Inventory and shortage conditions
- Mix between high- and low-concentration presentations
- Exposure to hospital tender renewals
- Foreign-exchange movement in international markets
Margin outlook
Gross-margin pressure is likely over the long term because:
- The product is mature and largely off-patent.
- Generic suppliers can bid directly against the reference brand.
- Hospitals have purchasing leverage.
- Contrast media are exposed to tender-based pricing.
- Sterile manufacturing and quality requirements limit, but do not eliminate, competition.
Margins can improve temporarily during constrained supply, but shortage-driven pricing is not a durable base case.
What generic launch risks exist for OMNIPAQUE 70?
Generic launch risk is high in principle because the active ingredient is mature and patent protection is not a meaningful barrier. The practical risk is moderated by technical and operational requirements.
High-risk factors
- Additional iohexol suppliers entering large hospital tenders
- Price reductions by existing generic suppliers
- Loss of preferred-contract status
- Substitution from Omnipaque to other nonionic agents
- Regional reimbursement pressure
- Product-specific packaging being excluded from contracts
Entry barriers
- Sterile injectable manufacturing
- Compliance with FDA current good manufacturing practice requirements
- Validation of concentration and impurity controls
- Reliable supply of iodine-containing intermediates
- Container-closure integrity
- Distribution scale
- Hospital quality audits
Generic entry is therefore commercially feasible but operationally demanding.
What patent litigation and settlement agreements affect OMNIPAQUE 70?
No major current patent litigation or settlement agreement is central to the U.S. commercial position of Omnipaque 70. The product’s principal disputes, when they arise, are more likely to involve supply contracts, regulatory compliance, product liability, procurement, or manufacturing events than blocking patent litigation.
The absence of a current patent settlement structure reduces the probability of a delayed generic-entry scenario. Generic availability is more likely to track FDA approval, manufacturing capacity, and commercial contracting.
How does OMNIPAQUE 70 compare with newer contrast agents?
Omnipaque has the advantage of long clinical familiarity and broad procedural use. Newer or differently positioned products can compete through perceived tolerability, lower-osmolar characteristics, renal-risk protocols, packaging, or contracting.
| Factor |
OMNIPAQUE 70 |
Newer or alternative agents |
| Regulatory history |
Long and established |
Varies |
| Generic exposure |
High |
Varies |
| Clinical familiarity |
High |
Moderate to high |
| Price flexibility |
Limited by tender competition |
Depends on patent and brand status |
| Supply risk |
Material |
Also material |
| Switching cost |
Moderate because protocols and inventory are established |
Can be higher where revalidation is needed |
| Patent protection |
Weak |
Product-specific |
Key Takeaways
- OMNIPAQUE 70 generally refers to a 70 mL presentation of iohexol-based Omnipaque, not a separate patented molecule.
- GE HealthCare is the principal brand manufacturer, but product-specific revenue is not publicly disclosed.
- Omnipaque has no meaningful current new-drug exclusivity or core patent protection.
- Paragraph IV litigation is not the principal commercial risk.
- Generic iohexol, hospital tenders, and group purchasing contracts determine pricing pressure.
- Sterile manufacturing, quality systems, and supply reliability are more important barriers than patents.
- Contrast-media shortages can create temporary volume and pricing gains, but the long-term profile remains mature and margin-sensitive.
- The most likely financial trajectory is stable demand tied to imaging volumes, offset by generic pricing and procurement pressure.
FAQs
Is OMNIPAQUE 70 the same as iohexol?
Yes. Omnipaque is the branded product, and iohexol is its active pharmaceutical ingredient.
Is OMNIPAQUE 70 still patent protected?
The core iohexol product is not protected by a commercially meaningful current composition patent in the United States. Any packaging or formulation rights would need to be assessed separately.
Can hospitals substitute generic iohexol for OMNIPAQUE 70?
Substitution depends on the applicable regulatory approval, hospital formulary rules, procurement contracts, concentration, container configuration, and clinical protocol.
Does GE HealthCare disclose OMNIPAQUE 70 sales?
No. GE HealthCare reports its Pharmaceutical Diagnostics business at a broader segment level and does not separately disclose sales for the 70 mL presentation.
What is the main investment risk for OMNIPAQUE 70?
The main risks are generic price erosion, loss of hospital contracts, manufacturing interruptions, supply-chain volatility, and substitution by other iodinated contrast media.
References
- U.S. Food and Drug Administration. (2024). Omnipaque (iohexol injection) prescribing information.
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
- U.S. Food and Drug Administration. (2022). Drug shortages: Iohexol and other iodinated contrast media supply updates.
- GE HealthCare Technologies Inc. (2024). Annual report on Form 10-K for the fiscal year ended December 31, 2023.
