Last updated: September 9, 2026
ULTRAVIST 240 is Bayer’s iopromide injection containing 240 mg of iodine per mL. It is a mature, nonionic, low-osmolar iodinated contrast medium used in diagnostic imaging. Its commercial value comes from recurring hospital and imaging-center procedure volumes rather than exclusivity-driven pricing. Product-level revenue is not publicly disclosed, so the financial trajectory must be assessed through Bayer’s broader Radiology business, market structure, pricing, and competitive risk.
What is ULTRAVIST 240 and how is it used?
ULTRAVIST 240 is an injectable radiographic contrast agent. Its active ingredient is iopromide, a low-osmolar, nonionic monomer used to improve visualization during X-ray-based imaging procedures.
The 240 concentration is used in selected diagnostic procedures where a lower iodine concentration is clinically appropriate. Depending on jurisdiction and indication, iopromide products are used in:
- Computed tomography of the head and body
- Digital subtraction angiography
- Peripheral and visceral angiography
- Cerebral angiography
- Renal and visceral imaging
- Intravenous excretory urography
- Other contrast-enhanced radiographic examinations
The FDA-approved ULTRAVIST product is marketed by Bayer HealthCare Pharmaceuticals. The U.S. product label identifies the active ingredient as iopromide and the product as an injectable contrast medium approved under NDA 019201.[1]
ULTRAVIST 240 is part of a broader iopromide franchise that includes other iodine concentrations, including 300 and 370 mg iodine/mL. The concentration portfolio allows Bayer to address different imaging protocols and procurement specifications.
What is the FDA regulatory status of ULTRAVIST 240?
ULTRAVIST 240 is an FDA-approved drug product, not a biologic. It is administered by healthcare professionals in hospitals, outpatient imaging centers, radiology departments, and interventional facilities.
The principal regulatory characteristics are:
| Attribute |
ULTRAVIST 240 |
| Active ingredient |
Iopromide |
| Strength |
240 mg iodine/mL |
| Dosage form |
Sterile injectable solution |
| Therapeutic category |
Iodinated radiographic contrast medium |
| FDA pathway |
New Drug Application |
| U.S. NDA |
019201 |
| Primary commercial holder |
Bayer |
| Administration |
Intravenous and intra-arterial, depending on procedure |
| Prescription status |
Institutional and professional use |
| Biosimilar pathway |
Not applicable |
| Generic pathway |
Abbreviated New Drug Application pathway may apply |
The product’s mature regulatory status reduces development risk for competitors. Generic manufacturers do not need to reproduce Bayer’s full clinical development program. They generally must establish pharmaceutical equivalence, bioequivalence where applicable, quality, manufacturing controls, and a satisfactory regulatory record.
When does ULTRAVIST 240 lose exclusivity?
ULTRAVIST 240 has passed the period in which market protection would normally depend on primary composition-of-matter patents or regulatory exclusivity. Iopromide was developed decades ago, and the product competes in a mature injectable contrast-media market.
The key commercial point is that ULTRAVIST 240 is no longer protected primarily by a high-value patent moat. Its defenses are more likely to come from:
- Manufacturing scale
- Sterile injectable production capacity
- Hospital formulary relationships
- Procurement contracts
- Regulatory compliance history
- Supply reliability
- Product breadth across iodine concentrations
- Physician familiarity
- Distribution infrastructure
Public FDA product information does not establish a current, commercially material patent term that would prevent generic competition with the active ingredient. Orange Book-listed patent protection, if any, should be assessed at the specific NDA and product level because injectable formulations and labeling claims can be treated differently from the underlying active ingredient.[2]
What patents protect ULTRAVIST 240?
The original iopromide patent estate is historical rather than a current exclusivity driver. Any early patents covering iopromide, its chemical preparation, or pharmaceutical compositions would have expired after the standard patent term.
Potential patent categories associated with an iodinated contrast product include:
| Patent category |
Commercial relevance for ULTRAVIST 240 |
| Composition-of-matter patent |
Historical; expected to be expired |
| Chemical synthesis patent |
Potential manufacturing relevance if still enforceable, but unlikely to block ordinary generic entry |
| Formulation patent |
May cover excipients, concentration, stability, or container design |
| Method-of-use patent |
May cover a defined imaging use or patient population |
| Manufacturing patent |
Could affect process design without blocking the product broadly |
| Device or packaging patent |
May affect presentation, vial, syringe, or administration system |
For a mature contrast agent, formulation and manufacturing patents may create narrower barriers than an active-ingredient patent. They generally do not prevent competitors from developing an alternative formulation that meets FDA quality requirements.
Patent strength is therefore low to moderate from a lifecycle perspective. Bayer retains practical know-how and manufacturing capability, but those assets are harder to measure and less legally durable than an unexpired composition patent.
How strong is the ULTRAVIST 240 patent estate?
The patent estate is weak as a source of long-term market exclusivity and stronger as a source of operational protection.
A practical assessment is:
| Dimension |
Assessment |
| Active-ingredient protection |
Low |
| Regulatory exclusivity |
Low for a mature product |
| Formulation protection |
Potentially narrow |
| Manufacturing know-how |
Moderate |
| Supply-chain barrier |
Moderate to high |
| Hospital contracting advantage |
Moderate |
| Brand retention |
Moderate |
| Ability to prevent generic entry |
Low |
| Ability to defend premium pricing |
Low to moderate |
The most defensible commercial assets are not likely to be patent claims. They are validated sterile manufacturing processes, global regulatory files, supply continuity, quality systems, and access to large institutional purchasing accounts.
What generic entry risks exist for ULTRAVIST 240?
Generic entry risk is material. Iopromide is a small-molecule injectable product, so it is exposed to conventional generic competition rather than biosimilar competition.
Potential competitors can pursue approval through an ANDA or another applicable abbreviated regulatory pathway. Competitive entry may focus on:
- Iopromide injection at 240 mg iodine/mL
- Other iopromide concentrations
- Substitute nonionic contrast agents
- Hospital contrast-media tenders
- Private-label or contract-manufactured presentations
The most likely generic launch pattern is gradual rather than an immediate nationwide substitution. Hospitals often use multisource contracting, and contrast-agent purchasing is influenced by price, supply reliability, radiology workflow, injector compatibility, and existing formularies.
Generic penetration risk is highest in price-sensitive public hospitals and large group purchasing organization contracts. It is lower where Bayer has a broad supply agreement covering several contrast agents or where procurement teams prioritize continuity and global quality history.
Which companies compete with ULTRAVIST 240?
ULTRAVIST 240 competes with both direct iopromide alternatives and other iodinated contrast media.
Direct and adjacent competitors
| Company |
Relevant products or franchise |
| GE HealthCare |
Omnipaque, iohexol |
| Guerbet |
Xenetix, iobitridol; broader contrast portfolio |
| Bracco |
Iopamidol products, including Isovue in the U.S. |
| Bayer |
Ultravist, iopromide |
| Jiangsu Hengrui and other regional manufacturers |
Generic iodinated contrast products in selected markets |
| Fresenius Kabi and regional injectable suppliers |
May compete through hospital procurement channels depending on country |
The principal competitive products are not necessarily exact molecular substitutes. Radiology departments may compare iopromide with iohexol, iopamidol, ioversol, iodixanol, and ioxilan based on procedure, renal-risk protocols, price, supply, and physician preference.
Bayer’s competitive position is strongest when it sells a complete radiology portfolio rather than ULTRAVIST 240 alone. Portfolio negotiations can link iodinated contrast products with MRI contrast agents and related hospital supply arrangements.
What is the financial trajectory of ULTRAVIST 240?
Bayer does not publicly report ULTRAVIST 240 revenue as a standalone line item. The product is included within Bayer’s broader Radiology business, which also contains other contrast agents and radiology-related products.
That reporting structure prevents a reliable public calculation of:
- Annual ULTRAVIST 240 net sales
- Product-level operating margin
- Unit volume
- Average selling price
- Regional revenue
- Generic erosion by country
- Revenue contribution from the 240 concentration alone
The expected financial trajectory is nevertheless identifiable:
Historical phase
ULTRAVIST benefited from the expansion of CT, angiography, and hospital imaging infrastructure. During the product’s earlier commercial life, brand recognition, regulatory approvals, and limited generic competition supported stronger pricing and market penetration.
Mature phase
The product now operates in a stable but price-sensitive market. Revenue depends mainly on procedure volumes, tender wins, concentration mix, supply performance, and the number of active hospital accounts.
Current phase
The principal pressures are:
- Generic and private-label competition
- Hospital purchasing consolidation
- Tender-based price reductions
- Substitution by other iodinated agents
- Product shortages caused by manufacturing or logistics interruptions
- Greater scrutiny of contrast-agent utilization
- Stable or modest growth in mature imaging markets
Volume can remain resilient even when revenue declines because diagnostic imaging is embedded in hospital care. A mature contrast product can retain significant cash generation despite low patent protection, provided manufacturing costs and distribution are controlled.
How do imaging volumes affect ULTRAVIST 240 demand?
Demand is linked to procedure volumes rather than chronic patient use. Key drivers include:
- CT scan growth
- Interventional cardiology and vascular procedures
- Emergency-department imaging
- Oncology diagnosis and follow-up
- Aging populations
- Expansion of outpatient imaging
- Healthcare access in emerging markets
- Replacement of older imaging equipment
Demand can weaken when hospitals defer elective procedures, reduce imaging budgets, or shift procurement to lower-cost alternatives. It can increase when outpatient imaging expands or when interventional procedures grow.
The product has a more defensive demand profile than drugs dependent on discretionary prescriptions. However, individual product revenue remains exposed to formulary substitution because contrast media are purchased institutionally.
What manufacturing and supply barriers affect ULTRAVIST 240?
Sterile injectable manufacturing creates a meaningful operational barrier. A competitor must maintain:
- Validated aseptic production
- Consistent iodine concentration
- Low particulate levels
- Container-closure integrity
- Stability through shelf life
- Sterility assurance
- Reliable raw-material supply
- Regulatory compliance across multiple markets
Iodinated contrast agents also require specialized supply-chain planning. Disruptions can arise from manufacturing shutdowns, raw-material constraints, packaging shortages, transportation failures, or sudden changes in imaging demand.
These barriers do not create patent exclusivity, but they can limit the number of credible suppliers. A generic manufacturer with regulatory approval but inconsistent supply may fail to displace an established brand in hospital contracts.
What litigation and settlement risks affect ULTRAVIST 240?
No major current U.S. patent litigation or Paragraph IV settlement is identified here as a primary commercial driver for ULTRAVIST 240. That is consistent with the product’s age and the absence of a strong, current composition-patent barrier.
Paragraph IV litigation would become relevant only if a generic applicant alleged that a listed patent was invalid, unenforceable, or not infringed. For a mature iopromide injection, the more likely competitive process is regulatory approval followed by commercial tender competition rather than extended patent litigation.
Product-liability, manufacturing-quality, and supply litigation could have greater practical relevance than patent litigation. Such events can affect hospital confidence, regulatory status, and Bayer’s broader radiology contracts.
How does ULTRAVIST 240 compare with competing contrast agents?
| Factor |
ULTRAVIST 240 |
Omnipaque |
Isovue and comparable iopamidol products |
| Active ingredient |
Iopromide |
Iohexol |
Iopamidol |
| Product maturity |
Mature |
Mature |
Mature |
| Market protection |
Limited |
Limited |
Limited |
| Primary advantage |
Bayer radiology portfolio and supply network |
Broad adoption and concentration range |
Established hospital use |
| Generic exposure |
High |
High |
High |
| Main purchasing driver |
Price, supply, protocol fit |
Price, supply, protocol fit |
Price, supply, protocol fit |
| Biosimilar risk |
None |
None |
None |
| Patent-led growth potential |
Low |
Low |
Low |
ULTRAVIST 240 is commercially comparable to other low-osmolar, nonionic contrast agents. Clinical differentiation is generally narrower than in specialty pharmaceuticals. Procurement economics and operational reliability often have greater influence than brand positioning.
What is the outlook for ULTRAVIST 240 revenue?
The likely outlook is stable to declining revenue per unit, offset partly by imaging-volume growth and portfolio management.
A reasonable business interpretation is:
- Unit demand should remain supported by CT and interventional imaging.
- Average selling prices should face pressure from tenders and generics.
- Product-level revenue should decline if Bayer loses institutional contracts or if low-cost competitors expand.
- Bayer can protect broader Radiology revenue through portfolio selling and supply reliability.
- Profitability should depend on manufacturing utilization, procurement efficiency, and mix across geographies and concentrations.
ULTRAVIST 240 is therefore more valuable as a durable cash-generating product within Bayer’s Radiology platform than as a standalone growth asset.
Key Takeaways
- ULTRAVIST 240 is Bayer’s iopromide 240 mg iodine/mL injection.
- It is an FDA-approved mature iodinated contrast medium under NDA 019201.
- Patent exclusivity is not the primary current commercial defense.
- Biosimilar risk does not apply; generic and therapeutic-substitution risk do.
- Product-level revenue is not separately disclosed by Bayer.
- Financial performance depends on imaging volumes, hospital tenders, pricing, supply reliability, and Bayer’s broader radiology portfolio.
- Sterile manufacturing and regulatory compliance create practical barriers but do not prevent generic entry.
- The most likely trajectory is stable procedure-linked demand with gradual price pressure.
- Current commercial strength is operational and contractual rather than patent-based.
- No major Paragraph IV litigation or settlement is identified as a central current risk driver.
FAQs
Is ULTRAVIST 240 a biologic drug?
No. ULTRAVIST 240 is a small-molecule iodinated contrast agent containing iopromide. It is not subject to the biosimilar approval pathway.
Can a generic manufacturer copy ULTRAVIST 240?
Yes. A qualified manufacturer can seek approval for an equivalent iopromide injectable product through the applicable abbreviated regulatory pathway, subject to FDA requirements for quality, equivalence, and manufacturing controls.
Does ULTRAVIST 240 have active U.S. patent protection?
The product is mature, and its commercial position is not generally dependent on an active composition-of-matter patent. Any remaining formulation, manufacturing, packaging, or method-of-use claims would require product-specific patent review.
Who owns ULTRAVIST 240?
ULTRAVIST is a Bayer product. Bayer HealthCare Pharmaceuticals is identified as the U.S. marketing entity in FDA product information.
What is the main investment risk for ULTRAVIST 240?
The main risk is commercial erosion from generic competition, hospital tender pricing, and substitution by other iodinated contrast agents. Supply reliability and Bayer’s ability to retain portfolio contracts are more important than patent expiry at this stage.
References
-
U.S. Food and Drug Administration. (2023). Ultravist (iopromide injection) prescribing information. Bayer HealthCare Pharmaceuticals Inc.
-
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.
-
Bayer AG. (2024). Annual report 2023. Bayer AG.
-
U.S. Food and Drug Administration. (2024). Generic drug user fee amendments and abbreviated new drug application resources. U.S. Department of Health and Human Services.
-
International Society for Magnetic Resonance in Medicine. (2024). Contrast media and radiology market resources. ISMRM.
