Last updated: September 24, 2026
ULTRAVIST 370 is Bayer’s high-concentration, nonionic, low-osmolar iodinated contrast agent containing iopromide at 769 mg/mL, equivalent to 370 mg iodine/mL. Its market position is mature and cash-generative rather than exclusivity-driven. The product competes primarily on imaging performance, hospital formulary access, supply reliability, injector compatibility, and price.
Bayer does not publicly report ULTRAVIST 370 revenue separately. Financial exposure must therefore be assessed through Bayer’s broader Radiology business, which includes contrast media products and related commercial activities. The product’s U.S. regulatory exclusivity and core composition patents are long expired or commercially exhausted. Current barriers are manufacturing scale, regulatory compliance, customer contracts, clinical familiarity, and supply-chain reliability.
What is ULTRAVIST 370 and how is it used?
ULTRAVIST 370 is an injectable contrast medium used to improve visualization during radiographic procedures. Its active ingredient is iopromide, a nonionic monomeric iodinated compound.
| Product attribute |
ULTRAVIST 370 |
| Brand owner |
Bayer AG |
| Active ingredient |
Iopromide |
| Iodine concentration |
370 mg iodine/mL |
| Chemical form |
Nonionic, low-osmolar contrast agent |
| Primary dosage form |
Sterile injection |
| Main applications |
Contrast-enhanced CT, angiography, intra-arterial digital subtraction angiography, and selected radiographic procedures |
| U.S. regulatory status |
FDA-approved prescription drug |
| Commercial category |
Diagnostic imaging contrast medium |
| Primary customers |
Hospitals, imaging centers, radiology departments, outpatient facilities |
| Main commercial competitors |
Omnipaque, Visipaque, Isovue, Optiray, and other iodinated contrast agents |
The 370 mg iodine/mL concentration is used where high iodine delivery is needed, including CT angiography and vascular imaging. Product selection depends on the procedure, injection rate, patient risk profile, local protocols, and the availability of compatible injectors.
How large is the market for iodinated contrast media?
The iodinated contrast media market is a mature hospital-supply market with recurring demand. Volume is linked to CT utilization, angiography, interventional cardiology, emergency medicine, oncology imaging, and outpatient diagnostic expansion.
Market growth is driven by:
- Increasing CT and CT angiography procedures.
- Higher imaging use in oncology and cardiovascular disease.
- Expansion of outpatient imaging centers.
- Greater use of contrast-enhanced imaging in emergency departments.
- Replacement demand from aging imaging infrastructure.
- Growth in healthcare access in emerging markets.
Market constraints include:
- Generic and multisource competition.
- Hospital purchasing pressure.
- Group purchasing organization negotiations.
- Limited clinical differentiation among established nonionic iodinated agents.
- Exposure to raw-material, sterile manufacturing, and logistics disruptions.
- Reimbursement pressure on outpatient imaging.
Contrast media demand is less discretionary than demand for many branded medicines. Once a hospital has established a contrast protocol, switching can create operational work involving injector settings, order sets, formularies, staff training, and supply qualification. That creates retention value for established products even after patent expiry.
What is the FDA regulatory status of ULTRAVIST 370?
ULTRAVIST is an FDA-approved iopromide injection product marketed by Bayer. The U.S. product was approved in the 1990s, placing it in a mature post-exclusivity phase. FDA labeling identifies ULTRAVIST formulations by iodine concentration, including 240, 300, and 370 mg iodine/mL products.[1]
The regulatory position is defined by an approved new drug application rather than current clinical exclusivity. FDA approval supports continued marketing if Bayer maintains manufacturing compliance, labeling, pharmacovigilance, and supply obligations.
The principal regulatory risks are operational:
- Manufacturing deviations.
- Sterility failures.
- Container or closure defects.
- Recalls.
- Labeling changes.
- Shortages or allocation events.
- Failure to maintain site compliance.
These risks can affect sales more directly than patent litigation because contrast media are administered in high volumes and hospitals generally require uninterrupted supply.
What is the Orange Book status of ULTRAVIST 370?
ULTRAVIST is an FDA-approved drug product, but the commercial value of any original composition or formulation exclusivity has expired. The product is not protected by a current market exclusivity period comparable to a new chemical entity, pediatric exclusivity period, or orphan-drug exclusivity.
The FDA Orange Book is relevant for determining listed patents and generic regulatory pathways. For a mature iopromide injection product, the absence of a commercially meaningful active patent estate means that market access depends primarily on approval of a competing product and the ability to manufacture it consistently.[2]
Orange Book status should be distinguished from:
- FDA approval of the drug product.
- Patent listings associated with the product.
- FDA exclusivity periods.
- State or hospital formulary restrictions.
- Commercial contracts and supply arrangements.
A product can remain commercially important after its Orange Book exclusivity value has fallen to zero.
What patents protect ULTRAVIST 370?
The core iopromide composition is an old small-molecule technology. Original composition-of-matter patents and early formulation protections are no longer the principal source of commercial protection.
| Protection category |
Current commercial relevance |
| Iopromide composition patents |
Expired or commercially exhausted |
| Original manufacturing patents |
Generally expired, unless a narrow process claim remains enforceable |
| Injection formulation patents |
Limited value for a mature product |
| Device or injector compatibility claims |
Potentially relevant but not a broad ULTRAVIST 370 monopoly |
| Method-of-use patents |
Limited value because the principal diagnostic uses are established |
| Trade secrets |
Relevant to process controls, impurity management, and manufacturing know-how |
| Regulatory approvals |
Necessary for sale but do not create long-term market exclusivity |
No single patent is likely to prevent a qualified competitor from developing an iopromide injection product. The meaningful IP risk is narrower: a competitor could encounter process patents, formulation claims, manufacturing know-how, or device-related claims in particular jurisdictions.
The practical IP position is therefore weak relative to a recently launched pharmaceutical. Bayer’s competitive advantage comes from scale and installed use rather than a durable patent barrier.
When does ULTRAVIST 370 lose exclusivity?
ULTRAVIST 370 lost the economic value of primary pharmaceutical exclusivity years ago. The product’s U.S. approval dates to the 1990s, and any original new-drug exclusivity and foundational patent protection have expired.
There is no expected future patent cliff comparable to a protected specialty medicine. Instead, ULTRAVIST 370 is already in a post-exclusivity market where erosion occurs incrementally through:
- Hospital contracting.
- Regional tendering.
- Competitor supply availability.
- Product shortages.
- Price concessions.
- New generic or multisource approvals.
- Shifts between contrast concentrations.
The absence of a single imminent expiry date reduces cliff risk but does not eliminate price pressure.
Which companies compete with ULTRAVIST 370?
ULTRAVIST 370 competes with several established iodinated contrast products.
| Company |
Competing product |
Active ingredient |
Competitive position |
| GE HealthCare |
Omnipaque |
Iohexol |
Broad hospital and imaging-center presence |
| GE HealthCare |
Visipaque |
Iodixanol |
Iso-osmolar positioning |
| Bracco |
Isovue |
Iopamidol |
Established U.S. radiology franchise |
| Guerbet |
Optiray |
Ioversol |
Established nonionic contrast competitor |
| Bayer |
Ultravist |
Iopromide |
Global branded contrast franchise |
| Generic manufacturers |
Various |
Multiple iodinated agents |
Price and supply competition |
ULTRAVIST 370 is not differentiated by a unique therapeutic outcome in the manner of a targeted oncology drug. Physicians and hospitals generally evaluate contrast agents through a combination of imaging quality, safety protocols, administration characteristics, procurement economics, and supply continuity.
How strong is the patent estate for ULTRAVIST 370?
The patent estate is weak as a blocking estate and moderate as a portfolio of technical know-how.
Blocking strength
Low. The original active ingredient and principal clinical uses are mature. A competitor that obtains regulatory approval and establishes compliant sterile manufacturing would not normally face a broad, durable composition patent barrier.
Manufacturing strength
Moderate. Iopromide injection requires validated synthesis, impurity control, sterile filling, container-closure integrity, stability data, and reliable high-volume production. These requirements create practical barriers even when patents do not.
Commercial strength
Moderate to high in established accounts. Bayer’s supply history, regulatory record, brand recognition, and global contracting can support retention. These advantages are commercial, not exclusivity-based.
Litigation strength
Limited for an Orange Book-style patent challenge. The likely disputes would involve manufacturing processes, formulation details, trade secrets, supply contracts, regulatory data, or alleged unfair competition rather than a major Paragraph IV campaign against a core composition patent.
What Paragraph IV challenges and generic entry risks exist?
A Paragraph IV challenge is most relevant when a generic applicant certifies that a listed patent is invalid, unenforceable, or will not be infringed. For a mature iopromide injection product, the commercial relevance of a new Paragraph IV action depends on whether an enforceable, unexpired patent is listed for the specific product and whether the challenger can obtain FDA approval.
The principal generic-entry scenarios are:
| Scenario |
Probability profile |
Commercial effect |
| No new approved competitor |
Ongoing possibility |
Bayer retains pricing and account stability |
| One approved multisource product |
Material |
Selective hospital price pressure |
| Multiple approved suppliers |
Higher erosion risk |
Tender-driven price reductions |
| Supply disruption at Bayer |
High short-term sensitivity |
Competitors gain temporary share |
| Competitor with lower-cost manufacturing |
Material |
Increased GPO and hospital discounts |
| New formulation or delivery system |
Lower probability |
May shift selected procedure volume |
Generic entry would probably affect price before it displaced all volume. Hospitals may dual-source contrast media to reduce shortage risk, while maintaining Bayer products for protocol continuity.
What manufacturing and supply barriers protect ULTRAVIST 370?
The key barriers are not patent barriers. They are manufacturing and regulatory barriers.
Iopromide injection requires:
- High-purity active pharmaceutical ingredient.
- Consistent iodine concentration.
- Control of organic and inorganic impurities.
- Aseptic or terminally sterilized injectable manufacturing.
- Container-closure integrity.
- Stability across storage and transport conditions.
- High-volume packaging and distribution.
- FDA and other jurisdictional site compliance.
Contrast agents are also vulnerable to sudden demand spikes. A production interruption can affect multiple hospitals because the products are procedural inputs rather than long-cycle prescription medicines. Bayer’s established manufacturing network and quality systems can therefore have economic value even without exclusivity.
What is the financial trajectory for ULTRAVIST 370?
Bayer does not disclose standalone ULTRAVIST 370 revenue, unit volume, gross margin, or product-level growth. The product is included within Bayer’s broader Radiology business, alongside other contrast media and radiology-related products.
The expected financial trajectory is mature and defensive:
- Revenue is likely to track imaging procedure volumes, hospital contracts, geographic expansion, and pricing.
- Volume growth can offset some price erosion in expanding CT and outpatient markets.
- Margin depends heavily on manufacturing utilization, raw-material costs, logistics, and tender discounts.
- A large portion of product value comes from recurring institutional demand rather than patent-protected pricing.
- Product-specific revenue cannot be inferred reliably from Bayer’s consolidated pharmaceutical sales.
Bayer’s Pharmaceuticals division has historically included Radiology among its operating areas, but public reporting does not isolate ULTRAVIST 370. Investors should avoid treating total Bayer Radiology sales as ULTRAVIST revenue because the segment includes multiple products and concentrations.[3]
Revenue exposure by market factor
| Factor |
Direction for ULTRAVIST 370 |
Financial implication |
| CT procedure growth |
Positive |
Supports volume |
| Cardiac and vascular imaging |
Positive |
Supports use of high-concentration products |
| Hospital tenders |
Negative for price |
Compresses net revenue |
| Competitor shortages |
Positive temporarily |
Can increase share |
| Bayer manufacturing disruption |
Negative |
Risks lost volume and account substitution |
| Generic entry |
Negative |
Increases discounting |
| Emerging-market imaging expansion |
Positive |
Creates volume growth but often at lower prices |
| Raw-material inflation |
Negative |
Pressures gross margin |
| Outpatient imaging growth |
Mixed |
Adds volume but increases purchasing pressure |
What litigation affects ULTRAVIST 370?
There is no widely recognized current U.S. patent litigation campaign that defines the commercial outlook for ULTRAVIST 370. The product is too mature for a conventional high-value patent-cliff dispute to be the central risk.
Relevant legal exposure is more likely to involve:
- Manufacturing process patents.
- Trade-secret allegations.
- Product liability claims.
- Failure-to-warn claims.
- Supply and distribution contracts.
- Antitrust or procurement disputes.
- Regulatory enforcement following manufacturing deviations.
Product-liability risk applies to iodinated contrast media as a class, including hypersensitivity reactions, renal safety concerns, extravasation injuries, and other known risks reflected in labeling. These risks are managed through warnings, clinical protocols, screening, and post-market surveillance rather than patent litigation.[1]
How does ULTRAVIST 370 compare with competing contrast agents?
ULTRAVIST 370 has a broadly comparable commercial profile to other established nonionic low-osmolar agents. Its strongest differentiators are Bayer’s global sales infrastructure, product familiarity, and supply relationships.
| Criterion |
ULTRAVIST 370 |
Omnipaque |
Visipaque |
Isovue |
| Active ingredient |
Iopromide |
Iohexol |
Iodixanol |
Iopamidol |
| Iodine concentration options |
Includes 370 mg/mL |
Includes high-concentration options |
Includes high-concentration options |
Includes high-concentration options |
| Osmolality profile |
Low-osmolar |
Low-osmolar |
Iso-osmolar |
Low-osmolar |
| Patent-driven differentiation |
Low |
Low for mature products |
Low to moderate depending on jurisdiction and claim |
Low |
| Main buying criteria |
Supply, protocol fit, price, quality |
Same |
Safety positioning, price, supply |
Same |
| Commercial maturity |
Mature |
Mature |
Mature |
Mature |
No product has an unlimited competitive advantage. Hospital decisions can change when a competitor offers a lower contract price, improved supply assurance, or a preferred concentration for a particular imaging protocol.
What generic launch scenarios exist for ULTRAVIST 370?
The most likely launch pattern is controlled institutional entry rather than immediate broad substitution.
Scenario one: limited generic entry
One approved competitor enters selected regional markets. Bayer protects share through contracting and service reliability. Net price declines modestly, with greater pressure in price-sensitive accounts.
Scenario two: multisource competition
Several suppliers receive approval. Hospitals and group purchasing organizations use competition to reduce prices. Bayer retains accounts where protocol continuity and supply performance justify a premium.
Scenario three: shortage-driven substitution
A supply interruption at any major supplier causes hospitals to qualify alternative contrast agents rapidly. Once an alternative is adopted, some of the temporary share gain can persist after supply normalizes.
Scenario four: differentiated delivery platform
A competitor pairs contrast media with injector technology, workflow software, or bundled imaging services. The commercial threat is greater than from a chemically similar generic because procurement shifts from product price to workflow economics.
What licensing deals support ULTRAVIST 370?
ULTRAVIST 370 is a mature Bayer product, and no major recent licensing transaction is required to sustain its market position. Public disclosures generally report Bayer’s Radiology business at an aggregate level rather than identifying licensing income or product-specific collaboration economics for ULTRAVIST 370.
The more relevant commercial arrangements are:
- Hospital and health-system supply contracts.
- Group purchasing organization agreements.
- Distributor arrangements.
- Regional registrations and commercialization agreements.
- Manufacturing and logistics contracts.
These arrangements can influence market share and pricing but do not create patent exclusivity.
Key Takeaways
- ULTRAVIST 370 contains iopromide at 370 mg iodine/mL and is used primarily for contrast-enhanced diagnostic imaging.
- Bayer does not disclose standalone ULTRAVIST 370 revenue.
- The product is in a mature post-exclusivity phase; original composition and core use protections have no meaningful remaining commercial life.
- The patent estate is weak as a blocking position. Manufacturing know-how and regulatory compliance are more important.
- The main competitors are Omnipaque, Visipaque, Isovue, and Optiray.
- Financial performance depends on CT and angiography volumes, hospital contracting, supply reliability, manufacturing cost, and generic competition.
- The most material commercial risk is gradual price erosion, not a single patent expiry.
- Generic entry would likely begin with institutional tenders and selective account conversion.
- Bayer’s competitive advantage is based on scale, quality systems, distribution, and customer familiarity.
- Product-level valuation requires internal Bayer sales data because public reporting aggregates Radiology revenue.
FAQs
Is ULTRAVIST 370 a generic drug?
ULTRAVIST 370 is a branded iopromide injection product. Its active ingredient is an established small molecule, and competing products may enter through applicable abbreviated or full regulatory pathways, depending on jurisdiction and product characteristics.
Does ULTRAVIST 370 have biosimilar risk?
No. ULTRAVIST 370 is a small-molecule iodinated contrast agent, not a biologic. Biosimilar regulation does not apply. Its competitive risk is generic or multisource competition.
Is iopromide still patent protected?
The original iopromide composition and core clinical-use protections are mature and no longer provide meaningful broad exclusivity. Narrow process or formulation claims may differ by jurisdiction and patent family.
What makes ULTRAVIST 370 commercially valuable after patent expiry?
Its value comes from hospital adoption, physician familiarity, validated imaging protocols, supply reliability, manufacturing scale, and Bayer’s contracting infrastructure.
Can hospitals switch from ULTRAVIST 370 to Omnipaque or Isovue?
Hospitals can qualify alternative iodinated contrast agents, but switching requires review of clinical protocols, concentration, injection parameters, formularies, procurement terms, and supply arrangements.
References
- U.S. Food and Drug Administration. (n.d.). Ultravist (iopromide injection) prescribing information. Bayer HealthCare Pharmaceuticals Inc. https://www.accessdata.fda.gov
- U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
- Bayer AG. (2024). Annual report 2023. https://www.bayer.com/en/investors/annual-reports
