Last updated: September 1, 2026
Iopromide is a mature, nonionic, low-osmolar iodinated contrast agent marketed primarily by Bayer under the Ultravist brand. Its commercial profile is driven by procedure volumes, hospital purchasing, supply reliability, manufacturing capacity, and price competition rather than patent exclusivity. Bayer does not separately disclose Ultravist revenue, so the product’s financial trajectory must be assessed through Bayer’s aggregate Radiology business and the broader iodinated contrast-media market.
What is iopromide and how is it used?
Iopromide is a water-soluble triiodinated contrast medium used to enhance radiographic imaging. In the United States, Ultravist is approved for several indications involving computed tomography, intra-arterial digital subtraction angiography, intra-arterial and intravenous angiography, and excretory urography, depending on concentration and administration route. The product is available in concentrations including 240, 300 and Ultravist 370 mg iodine/mL formulations. [1]
The drug is used in:
- Computed tomography of the head and body
- Cerebral, visceral, renal and peripheral angiography
- Coronary and left ventricular angiography
- Intravenous digital subtraction angiography
- Excretory urography
- Selected pediatric imaging procedures
Iopromide competes with other nonionic iodinated agents, including iohexol, iopamidol, iodixanol and ioversol.
What is the market size for iopromide and iodinated contrast media?
Iopromide is part of a larger global market for iodinated contrast media rather than a separately reported market category. Public company disclosures do not provide a verified global revenue figure for iopromide alone.
The relevant market has several characteristics:
| Market factor |
Effect on iopromide |
| CT and angiography procedure growth |
Supports demand |
| Mature clinical use |
Limits volume expansion from new indications |
| Hospital tenders |
Creates price pressure |
| Multiple nonionic competitors |
Reduces switching costs |
| Complex sterile manufacturing |
Limits rapid new entry |
| Supply disruptions |
Can temporarily increase demand for available products |
| Generic and private-label competition |
Compresses price and share |
| Contrast-agent shortages |
Increase the value of manufacturing redundancy |
Bayer reports Radiology as a business unit within its Pharmaceuticals division. The portfolio includes Ultravist, Gadovist/Gadavist, Primovist/Eovist and other imaging products. Bayer reports the portfolio in aggregate, not by individual product. In 2023, Bayer Pharmaceuticals generated approximately €18.1 billion in sales, while Radiology represented roughly €1.7 billion, subject to product and currency classifications in the company’s annual reporting. [2]
That figure is not iopromide revenue. It includes both iodinated and gadolinium-based contrast products. Ultravist is therefore a contributor to a broader radiology franchise rather than a separately valued public asset.
What is the financial trajectory for iopromide?
Iopromide’s financial trajectory is likely mature to declining in developed markets, with resilient demand in emerging markets and periodic revenue volatility from supply conditions.
Historical trajectory
Ultravist benefited from the replacement of older ionic and high-osmolar contrast agents with nonionic low-osmolar products. That conversion created substantial historical growth. The product is now established, and the market has shifted from clinical adoption to procurement economics.
Revenue drivers have changed over time:
- Earlier growth came from conversion to nonionic contrast media.
- Later growth came from higher CT, angiography and interventional procedure volumes.
- Current performance depends heavily on tender wins, geographic expansion and supply continuity.
- Pricing is constrained by hospital and group-purchasing negotiations.
- Mature-market sales are exposed to generic and competing branded products.
Bayer’s Radiology business has remained strategically important because contrast products generate recurring demand from routine imaging. The portfolio also benefits from cross-selling across CT, MRI and interventional radiology accounts.
Near-term financial outlook
The likely near-term profile is low-single-digit nominal growth or decline at the individual-product level, depending on geography. Revenue can rise when:
- Imaging volumes increase;
- Bayer gains hospital contracts;
- Competitors experience shortages;
- Emerging-market penetration expands;
- Higher-concentration presentations increase usage efficiency or average selling price.
Revenue can fall when:
- Generic suppliers win tenders;
- Hospitals switch to iohexol, iopamidol or ioversol;
- Public reimbursement budgets tighten;
- Bayer loses supply contracts;
- Procurement organizations consolidate purchasing.
The product’s margin profile is supported by scale, established manufacturing, regulatory familiarity and global distribution. It is constrained by sterile injectable production costs and tender pricing.
When does iopromide lose exclusivity?
Iopromide lost meaningful small-molecule exclusivity years ago. The active ingredient was approved in the United States in the 1990s, and the original new chemical entity exclusivity period has expired. Iopromide is not a current patent-protected innovation in the conventional small-molecule sense.
The commercial exclusivity timeline is therefore:
| Event |
Timing |
| U.S. approval of Ultravist |
1990s |
| Original NCE exclusivity |
Expired |
| Core compound patent protection |
Expired |
| Original formulation and process protection |
Generally expired or commercially immaterial |
| Current market position |
Brand, manufacturing and supply-chain driven |
A precise standalone patent-expiration date for the commercial product is less important than the absence of an active, high-value compound patent barrier. Iopromide’s current protection comes from brand recognition, regulatory files, manufacturing know-how, quality systems, customer contracts and global supply capacity.
What patents protect iopromide?
No active foundational patent estate is publicly relevant to the current commercial valuation of iopromide. The original compound, synthesis and formulation patents associated with the product date from the development and launch period. Those rights would generally have expired by the current market period, including any applicable patent-term adjustment or extension.
Formulation patents
Iopromide injectable products are sterile aqueous formulations containing the active contrast agent and excipients. Relevant formulation attributes include:
- Concentration of iodine
- Osmolality
- Viscosity
- pH
- Stability
- Container and closure system
- Sterility and particulate control
These attributes can be covered by historical formulation, packaging or manufacturing patents. They do not create a current market-wide exclusionary position comparable to a live composition-of-matter patent.
Method-of-use patents
Iopromide method-of-use patents are not a meaningful current barrier to routine CT or angiographic use. The major clinical uses are established, label-based applications. Method-of-use rights would also face limited commercial leverage because competing iodinated agents are approved for overlapping procedures.
Manufacturing and process barriers
Manufacturing is more important than patent ownership. Iopromide requires:
- Multi-step chemical synthesis
- High-purity intermediates
- Control of iodine-containing impurities
- Sterile filling
- Validated analytical testing
- Packaging suitable for injectable products
- Reliable global regulatory compliance
These requirements can delay entry even when patents have expired. They do not prevent entry by established injectable manufacturers with appropriate facilities.
What is the Orange Book status of iopromide?
Ultravist is an FDA-approved drug product associated with Bayer’s NDA. The key commercial issue is that iopromide is an old small molecule and does not depend on current Orange Book patent exclusivity.
The Orange Book framework is relevant to an innovator product only when listed patents remain enforceable and commercially significant. For iopromide, the practical risk profile is different:
- Core exclusivity has expired.
- Any historical listed patents are unlikely to block ordinary generic development.
- Generic approval can proceed through an abbreviated pathway if the applicant satisfies FDA requirements.
- Label overlap and product-specific safety information may affect the scope of a generic application.
FDA product labeling identifies Ultravist as a prescription injectable contrast medium manufactured by Bayer. [1] FDA’s Orange Book provides the formal reference for NDA, patent and exclusivity records. [3]
Which companies are challenging iopromide?
Competition is broader than a single Paragraph IV dispute. The relevant challengers are manufacturers of competing or generic iodinated contrast agents.
Potential competitive groups include:
- Branded manufacturers of iohexol, iopamidol, iodixanol and ioversol
- Generic injectable manufacturers
- Contract manufacturers supplying hospital systems
- Regional pharmaceutical companies in China, India, Latin America and other emerging markets
- Distributors offering multi-product contrast portfolios
Publicly available information does not establish a current, major Paragraph IV litigation campaign against Ultravist comparable to the patent challenges seen for newer specialty drugs. The main competitive threat is commercial substitution rather than litigation-driven generic entry.
What is the biosimilar risk for iopromide?
Iopromide has no biosimilar risk because it is a chemically synthesized small molecule, not a biologic. The relevant regulatory pathway is an ANDA or, in some circumstances, another drug application pathway, not a 351(k) biosimilar application.
The practical substitution risks are:
- Authorized or independent generic iopromide
- Therapeutic substitution to another iodinated contrast agent
- Hospital formulary replacement
- Tender-based switching among equivalent products
What Paragraph IV challenges affect Ultravist?
A Paragraph IV challenge would require a generic applicant to certify that relevant listed patents are invalid, unenforceable or not infringed. Iopromide’s age makes a major current Paragraph IV event less likely than for recently approved products.
The commercial impact of any Paragraph IV filing would depend on:
- Whether an Orange Book patent remains listed;
- Whether the patent covers the active ingredient, formulation or use;
- The generic applicant’s ability to satisfy injectable quality requirements;
- Whether a 30-month stay applies;
- Whether the parties settle before launch;
- Whether the FDA grants tentative or final approval.
No widely reported, current settlement agreement or litigation outcome materially changes the basic conclusion that iopromide is a post-exclusivity product.
What patent litigation affects iopromide?
The principal legal exposure is not a live patent cliff. It is ordinary product liability, manufacturing compliance, supply and procurement risk.
Potential litigation areas include:
- Patent disputes involving residual formulation or process claims;
- ANDA litigation if a listed patent remains relevant;
- Product-liability claims involving hypersensitivity, renal injury or extravasation;
- Manufacturing or quality disputes;
- Contract disputes with hospitals and distributors;
- Regulatory enforcement involving sterile injectable production.
The FDA label carries warnings related to hypersensitivity reactions, acute kidney injury risk, extravasation and other administration-related events. [1] These risks can affect legal reserves and insurance exposure even when they do not affect patent duration.
How strong is the iopromide patent estate?
The patent estate is weak as a current exclusivity asset but stronger as a commercial platform.
| Dimension |
Assessment |
| Composition-of-matter protection |
Expired |
| NCE exclusivity |
Expired |
| Current formulation exclusivity |
Limited |
| Method-of-use exclusivity |
Limited |
| Manufacturing know-how |
Moderate |
| Regulatory and quality barriers |
Moderate to high |
| Brand and hospital familiarity |
Moderate |
| Supply-chain value |
High during shortages |
| Generic substitution risk |
Moderate to high |
The product’s defense is operational rather than legal. Bayer’s advantages include regulatory history, established clinical use, manufacturing scale and broad account coverage.
How does iopromide compare with competing contrast agents?
| Product |
Active ingredient |
Commercial position |
Main competitive issue |
| Ultravist |
Iopromide |
Established Bayer brand |
Tender and generic pressure |
| Omnipaque |
Iohexol |
Major global branded product |
Broad hospital penetration |
| Isovue |
Iopamidol |
Established low-osmolar agent |
Formulary competition |
| Optiray |
Ioversol |
Competing nonionic agent |
Share and pricing pressure |
| Visipaque |
Iodixanol |
Iso-osmolar positioning |
Premium pricing and renal-risk positioning |
Iopromide competes primarily on clinical familiarity, availability, concentration range, handling characteristics, contract pricing and supply reliability. It does not possess a clear patent-based advantage over older competing agents.
What generic launch risks exist for iopromide?
Generic launch risk is real but gradual. Injectable contrast products require more than chemical equivalence. Applicants must demonstrate product quality, sterility, container compatibility, stability and appropriate labeling.
The most likely launch scenarios are:
Low-disruption scenario
One or two suppliers enter selected markets. Bayer retains major hospital accounts through contracts, service and supply reliability. Prices decline modestly.
Moderate-disruption scenario
Several generic or regional suppliers win tenders. Ultravist retains a branded share but experiences lower average selling prices and reduced volume in public hospitals.
High-disruption scenario
Multiple suppliers achieve broad approval while contrast-agent capacity expands. Hospitals treat iopromide as interchangeable with other nonionic agents, producing sustained price erosion.
Supply shortages can temporarily reverse this pattern. In a shortage, hospitals may prioritize whichever supplier can deliver validated sterile product, allowing branded products to preserve volume and pricing.
What licensing deals affect iopromide?
No major recently disclosed licensing transaction appears to define the current iopromide market. The product is primarily commercialized through Bayer’s own pharmaceutical and radiology infrastructure.
Licensing has greater relevance to:
- Regional distribution;
- Contract manufacturing;
- Local regulatory sponsorship;
- Hospital procurement arrangements;
- Generic supply agreements.
The absence of a material current licensing transaction means deal value is more likely to arise from manufacturing capacity or regional commercialization than from transfer of exclusive patent rights.
What geographic markets are most important?
North America, Western Europe, Japan and other developed markets provide stable procedure volumes but face pricing and tender pressure. Emerging markets offer stronger unit-growth potential but have lower average selling prices and greater competition from regional manufacturers.
| Region |
Market profile |
| United States |
High procedure volume, hospital purchasing pressure, established branded competition |
| Europe |
Tender-driven, price-sensitive, mature imaging infrastructure |
| Japan |
Mature market with established local and international suppliers |
| China |
Large imaging base, local manufacturing growth, price competition |
| India |
Expanding imaging demand, strong generic and local-manufacturer presence |
| Latin America |
Variable reimbursement and distributor dependence |
| Middle East and Africa |
Growth potential constrained by procurement and supply logistics |
Geographic diversification reduces dependence on a single reimbursement system but increases regulatory, distribution and supply-chain complexity.
What revenue exposure does Bayer have to iopromide?
Bayer does not publicly report Ultravist revenue as a standalone line item. The company reports Radiology revenue at an aggregate level covering several contrast agents.
The direct financial exposure is therefore:
- Lower than Bayer’s total Pharmaceuticals revenue;
- Lower than total Radiology revenue;
- Material to the radiology portfolio’s recurring cash flow;
- More exposed to price and volume changes than to patent expiry;
- Partly offset by Bayer’s MRI contrast products and broader imaging portfolio.
A decline in Ultravist would not necessarily translate one-for-one into a decline in Bayer Radiology sales because the portfolio contains multiple products and indications.
FDA regulatory status and commercial outlook
Ultravist remains an FDA-approved prescription contrast agent. Its regulatory status is mature, with established labeling and long clinical experience. [1]
The commercial outlook is stable but defensive:
- Demand should track CT, angiography and interventional procedure volumes.
- Patent expiry is no longer the central risk.
- Generic and therapeutic substitution will pressure pricing.
- Manufacturing reliability can protect share during shortages.
- Bayer’s broader radiology portfolio supports account retention.
- The product is unlikely to generate high-growth pharmaceutical economics without a new delivery, diagnostic or formulation innovation.
Key Takeaways
- Iopromide is a mature nonionic iodinated contrast agent marketed mainly by Bayer as Ultravist.
- Bayer does not disclose standalone Ultravist revenue.
- Bayer’s Radiology business, which includes Ultravist and MRI contrast agents, is the best public financial proxy.
- Original compound, NCE and core product exclusivity have expired.
- Current value comes from brand familiarity, regulatory history, manufacturing capability and supply reliability.
- No biosimilar pathway applies because iopromide is a small molecule.
- Generic and therapeutic substitution risk is moderate to high, but entry is constrained by sterile injectable manufacturing and quality requirements.
- The most important commercial variables are procedure volumes, hospital tenders, supply continuity and geographic mix.
- A major current Paragraph IV litigation or settlement event is not central to the product’s market outlook.
- Revenue is likely mature, with price pressure in developed markets and volume opportunity in emerging markets.
FAQs
Is iopromide the same as iohexol?
No. Iopromide and iohexol are different iodinated contrast agents, although both are nonionic, low-osmolar products used in overlapping imaging procedures.
Is Ultravist still protected by patents?
Ultravist is no longer protected by the original composition-of-matter or new chemical entity exclusivity associated with iopromide. Any residual formulation or process rights would have limited commercial scope relative to the expired core protection.
Can hospitals substitute iohexol for iopromide?
Hospitals can use different contrast agents when the alternative is approved for the relevant procedure and satisfies clinical, formulary and procurement requirements. Substitution decisions depend on protocol, concentration, physician preference, price and supply.
Does iopromide have a generic version?
Generic availability varies by jurisdiction and presentation. The product is legally eligible for generic competition because its core exclusivity has expired, but sterile manufacturing and regulatory requirements can limit the number of suppliers.
What is the main investment risk for Bayer’s iopromide business?
The main risk is sustained price and volume erosion from tender losses, generic entry, competing contrast agents and hospital procurement consolidation. Patent expiry is no longer the primary investment issue.
References
- U.S. Food and Drug Administration. (2023). Ultravist (iopromide injection) prescribing information. Bayer HealthCare Pharmaceuticals Inc.
- Bayer AG. (2024). Annual report 2023. Bayer AG.
- U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.
