Last updated: August 1, 2026
ISOVUE-370 is a high-concentration iodinated contrast medium containing iopamidol at 370 mg iodine/mL. Bracco Diagnostics markets it for radiographic procedures including contrast-enhanced computed tomography, angiography, intravenous digital subtraction angiography, and selected cardiac and visceral examinations. Its clinical development is complete; current activity is concentrated on postmarketing safety, procedural use, supply, and competition from other low-osmolar iodinated contrast agents.
ISOVUE-370 has limited conventional drug-development upside because it is an established diagnostic product with a mature safety profile and no disease-modifying mechanism. Revenue depends primarily on imaging volumes, hospital contracts, radiology utilization, pricing, product availability, and Bracco’s ability to retain share against GE HealthCare’s Omnipaque, Bayer’s Ultravist, and generic iopamidol products.
What is ISOVUE-370 and how is it used?
ISOVUE-370 is a nonionic, low-osmolar, water-soluble contrast agent for intravascular administration. Its active ingredient is iopamidol, an iodinated molecule that increases X-ray attenuation in vascular and soft-tissue imaging.
The product is supplied as an injectable solution with an iodine concentration of 370 mg/mL. Its principal uses include:
- Contrast-enhanced CT of the head and body
- Intra-arterial digital subtraction angiography
- Peripheral angiography
- Visceral angiography
- Renal angiography
- Coronary angiography and left ventricular imaging
- Intravenous angiography in selected patients
The FDA label identifies dosing by procedure, patient weight, imaging protocol, vascular territory, and clinical objective rather than by a single fixed dose. The administered volume can be substantial in angiographic procedures, while CT protocols generally use weight-based or protocol-based dosing.[1]
ISOVUE-370 is not a therapeutic medicine. It does not treat cancer, vascular disease, or neurologic disease. Its commercial value comes from enabling diagnostic imaging.
What is the FDA regulatory status of ISOVUE-370?
ISOVUE-370 is FDA-approved and marketed as a prescription radiopaque diagnostic agent. The product is regulated as a drug rather than as a medical device.
The FDA-approved label covers use in adults and, for selected procedures, pediatric populations. Key labeled risks include:
- Severe hypersensitivity reactions
- Contrast-induced acute kidney injury
- Extravasation and local tissue injury
- Thyroid dysfunction
- Cardiovascular and neurologic adverse reactions
- Drug interactions involving metformin in patients with impaired renal function
- Risk of cardiac arrhythmia or hemodynamic instability during certain angiographic procedures
The label requires screening for prior contrast reactions, renal impairment, thyroid disease, cardiovascular risk, and other relevant conditions. The FDA has not required a boxed warning for ISOVUE-370.[1]
FDA exclusivity and approval timing
Iopamidol is an established active ingredient. ISOVUE-370 does not have meaningful remaining New Chemical Entity exclusivity, pediatric exclusivity, or other market exclusivity comparable to recently approved innovative drugs.
The product’s commercial protection is based mainly on:
- Brand recognition
- Hospital and group purchasing contracts
- Manufacturing scale
- Product reliability and supply continuity
- Regulatory approvals in individual jurisdictions
- Clinical familiarity among radiologists and technologists
What clinical trials are evaluating ISOVUE-370?
There is no active therapeutic development program for ISOVUE-370 comparable to oncology, immunology, or cardiovascular drugs. The agent has completed its core clinical development.
Clinical evidence for iopamidol was generated through diagnostic imaging studies and comparative evaluations of safety, image quality, hemodynamic effects, renal outcomes, and adverse reactions. Current or recent studies involving iopamidol are more likely to evaluate:
- Contrast-associated acute kidney injury
- Strategies for reducing contrast volume
- Hydration and renal-protection protocols
- Contrast reactions and premedication
- Imaging protocols in vulnerable patient groups
- Comparisons among iodinated contrast agents
- Pediatric and emergency imaging practices
ClinicalTrials.gov records can include studies in which iopamidol is used as a comparator, procedural agent, or background contrast medium. These studies do not generally represent new clinical development of ISOVUE-370 as a branded product.[2]
Clinical-trial outlook
The probability of a major new clinical indication is low. Future evidence generation is more likely to focus on use optimization than on expanding the product’s label.
| Development area |
Outlook for ISOVUE-370 |
| New therapeutic indication |
Very low |
| New diagnostic indication |
Low |
| Pediatric protocol studies |
Possible |
| Renal-safety studies |
Likely to continue at class level |
| Low-contrast imaging studies |
Likely |
| Comparative contrast-agent studies |
Ongoing at industry level |
| Real-world safety studies |
Ongoing |
| Formulation innovation |
Limited |
What patents protect ISOVUE-370?
The original composition and product patents for iopamidol and early ISOVUE formulations are expired or commercially weak in the United States. ISOVUE-370 is an established product, and generic or multisource competition is legally possible.
The current patent position is more likely to involve narrow rights covering:
- Manufacturing processes
- Specific formulations or container systems
- Packaging and storage
- Administration protocols
- Combination use with imaging equipment
- Device-related delivery systems
These rights generally do not recreate broad exclusivity for the iopamidol active ingredient.
How strong is the ISOVUE-370 patent estate?
The patent estate is weak as a barrier to ordinary generic entry. A competitor that can obtain FDA approval for an equivalent iopamidol injection can compete without reproducing Bracco’s brand, packaging, or manufacturing process.
Patent strength is higher only where a specific process, container, presentation, or device is difficult to design around. Those rights would not normally prevent competition based on an independently developed iopamidol manufacturing process.
What is the Orange Book status of ISOVUE-370?
ISOVUE-370 is listed in FDA drug databases as a prescription injectable drug. Orange Book relevance is limited because the core active ingredient is old and the product does not depend on a current period of new-drug exclusivity.
Potential generic competitors may rely on an abbreviated pathway if they can demonstrate pharmaceutical equivalence, bioequivalence where applicable, and manufacturing compliance. Injectable contrast agents also face chemistry, manufacturing, and controls requirements that can make approval and commercial scale-up more difficult than the patent analysis alone suggests.[3]
The practical barriers are often:
- Sterile manufacturing capacity
- High-volume filling capability
- Iodinated raw-material supply
- Quality-control validation
- FDA inspection readiness
- Hospital contracting
- Distribution reliability
Which companies compete with ISOVUE-370?
ISOVUE-370 competes in the low-osmolar iodinated contrast market rather than in a conventional branded prescription-drug market.
| Product |
Active ingredient |
Principal company |
Competitive position |
| ISOVUE-370 |
Iopamidol |
Bracco Diagnostics |
Established high-concentration iopamidol product |
| Omnipaque iohexol |
Iohexol |
GE HealthCare |
Major global competitor with broad imaging use |
| Ultravist 370 |
Iopromide |
Bayer |
Direct high-concentration competitor |
| Optiray 350/320 |
Ioversol |
Guerbet |
Competes in CT and angiographic imaging |
| Visipaque |
Iodixanol |
GE HealthCare |
Iso-osmolar alternative, often positioned for selected renal-risk patients |
| Generic iopamidol |
Iopamidol |
Multiple manufacturers |
Price and supply competitor |
Omnipaque has a particularly strong competitive position because iohexol is used across CT, angiography, and other procedures and is widely integrated into hospital protocols. Ultravist 370 is a direct concentration and workflow competitor. Visipaque competes through its iso-osmolar positioning rather than chemical equivalence.
What generic entry risks exist for ISOVUE-370?
Generic-entry risk is high in legal terms but moderate in commercial execution.
A generic iopamidol product can compete on price if it satisfies FDA requirements. However, hospitals often evaluate contrast agents through broader procurement criteria:
- Total cost per imaging procedure
- Supply continuity
- Contract pricing
- Pharmacy and radiology workflow
- Injector compatibility
- Packaging and waste reduction
- Adverse-event experience
- Vendor service
- Product availability during shortages
Contrast-media shortages have shown that manufacturing redundancy and distribution capacity can materially affect market share. A lower-priced entrant without dependable supply may gain limited adoption.
Generic launch scenarios
| Scenario |
Market effect |
| No major new entrant |
Bracco retains a stable branded share, with gradual price pressure |
| One reliable generic entrant |
Contract pricing declines and hospital substitution increases |
| Multiple injectable suppliers |
Faster erosion in commodity accounts |
| Supply disruption at a major manufacturer |
Temporary share shifts and pricing volatility |
| Consolidated purchasing by health systems |
Higher pressure on branded net pricing |
What patent litigation and Paragraph IV challenges affect ISOVUE-370?
No major, publicly prominent Paragraph IV litigation currently defines the ISOVUE-370 market. That outcome is consistent with an old active ingredient and limited remaining composition-of-matter protection.
Paragraph IV litigation would be more likely if Bracco listed a relevant, enforceable formulation or process patent against a generic iopamidol applicant. In practice, litigation risk is lower than in markets protected by recent formulation patents, method-of-use patents, or complex drug-device combinations.
The principal legal risks are therefore commercial and regulatory:
- ANDA approval disputes
- Manufacturing-site compliance
- Product-quality investigations
- Supply and recall exposure
- Contract disputes
- Labeling and pharmacovigilance obligations
What formulations are protected by ISOVUE-370?
The commercial product is an aqueous, sterile injectable formulation of iopamidol at 370 mg iodine/mL. Relevant technical attributes include:
- Nonionic contrast chemistry
- High iodine concentration
- Sterile injectable presentation
- Controlled osmolality and viscosity
- Container compatibility
- Stability during storage
- Compatibility with power injectors and angiographic equipment
The formulation itself is not likely to provide durable broad exclusivity because injectable iopamidol products can be developed by other manufacturers. Protection is stronger at the process and quality-control level than at the basic formulation level.
When does ISOVUE-370 lose exclusivity?
ISOVUE-370 has already lost the exclusivity associated with a new active pharmaceutical ingredient. There is no credible late-life exclusivity event comparable to a patent cliff for a modern specialty drug.
The more relevant timeline is:
| Period |
Commercial status |
| Original development and approval |
Clinical and regulatory exclusivity established |
| Patent-expiration period |
Broad active-ingredient protection ended |
| Current market |
Mature branded product with generic-entry exposure |
| Forward period |
Gradual price and share pressure, subject to supply conditions |
Branded retention depends on procurement performance, manufacturing reliability, product availability, and customer relationships rather than on patent-backed exclusion.
What is the market size and revenue outlook for ISOVUE-370?
Public companies do not generally disclose standalone global revenue for ISOVUE-370. Bracco reports at the company and business-line level, while the product competes within a broader contrast-media portfolio. A precise product revenue figure is therefore not available from standard public filings.
The relevant addressable market is the global iodinated contrast-media market. Published market-research estimates vary because analysts apply different definitions covering CT contrast, angiographic agents, injectable and oral products, hospital purchases, and imaging equipment-linked revenue. Industry forecasts generally indicate mid-single-digit annual growth through the end of the decade, driven by:
- Rising CT utilization
- Aging populations
- Greater cardiovascular imaging
- Oncology surveillance
- Emergency-department imaging
- Expansion of imaging capacity in emerging markets
- Higher use of contrast-enhanced studies
Growth is constrained by:
- Contrast-media shortages
- Renal-safety concerns
- Lower-contrast imaging protocols
- Cost containment by hospitals
- Generic and tender-based procurement
- Alternative imaging methods in selected indications
A reasonable base-case projection for ISOVUE-370 is low-single-digit nominal revenue growth or flat revenue, depending on geography. Market growth may not translate directly into product growth because mature branded contrast agents face price competition.
| Projection factor |
Expected effect on ISOVUE-370 |
| Global CT volume growth |
Positive |
| U.S. hospital price pressure |
Negative |
| Generic iopamidol competition |
Negative |
| Supply reliability |
Positive and potentially decisive |
| Growth in angiography |
Positive |
| Lower-dose protocols |
Negative on volume per procedure |
| Bracco contracting strength |
Positive |
| New therapeutic indications |
Minimal effect |
Regional outlook
The United States is a large and commercially mature market with strong hospital purchasing pressure. Europe is also mature, with tendering and country-level reimbursement affecting pricing. Emerging markets offer imaging-volume growth but generally have lower prices and greater sensitivity to supply and procurement economics.
The highest-value opportunities are likely to remain in:
- North America
- Western Europe
- Japan
- South Korea
- Gulf imaging markets
- Large urban centers in China, India, and Southeast Asia
How does ISOVUE-370 compare with Omnipaque and Ultravist?
| Attribute |
ISOVUE-370 |
Omnipaque |
Ultravist 370 |
| Active ingredient |
Iopamidol |
Iohexol |
Iopromide |
| Iodine concentration |
370 mg/mL |
Multiple concentrations, including 350 |
370 mg/mL |
| Osmolality class |
Low-osmolar |
Low-osmolar |
Low-osmolar |
| Main competitors |
Iohexol, iopromide, ioversol |
Iopamidol, iopromide |
Iopamidol, iohexol |
| Patent barrier |
Low |
Low for core active ingredient |
Low for core active ingredient |
| Main advantage |
Established product and procedural familiarity |
Broad use and supply scale |
Direct high-concentration positioning |
| Primary risk |
Price and tender erosion |
Supply and contracting pressure |
Generic and branded competition |
Clinical choice is usually determined by institutional protocol, physician familiarity, patient risk, equipment, price, and supply rather than by large efficacy differences among modern low-osmolar agents.
What licensing deals affect ISOVUE-370?
No major recent licensing transaction is central to the commercial outlook for ISOVUE-370. Bracco’s position is based primarily on its own contrast-media portfolio, manufacturing, regulatory infrastructure, and commercial distribution.
Licensing or distribution arrangements may matter in individual countries, particularly where local registration, government procurement, or distributor access controls market entry. These arrangements are unlikely to create new global exclusivity for iopamidol.
Key Takeaways
- ISOVUE-370 is an established iopamidol 370 mg iodine/mL injectable contrast agent marketed by Bracco Diagnostics.
- Its clinical development is complete; current research concerns safety, contrast-volume reduction, renal outcomes, and imaging protocols.
- The product has no meaningful remaining new-drug exclusivity.
- Broad patent protection for the active ingredient has expired, making generic entry legally feasible.
- No major Paragraph IV litigation currently defines the product’s market.
- The principal commercial competitors are Omnipaque, Ultravist, Optiray, Visipaque, and generic iopamidol.
- Public standalone revenue for ISOVUE-370 is not disclosed.
- The broader iodinated contrast market is expected to grow at a mid-single-digit rate, but ISOVUE-370 is more likely to deliver stable or low-single-digit revenue growth because of pricing and tender pressure.
- Manufacturing reliability, sterile capacity, hospital contracts, and supply continuity are more important than patent exclusivity in determining future share.
FAQs
Is ISOVUE-370 a generic drug?
ISOVUE-370 is a branded iopamidol product. Generic iopamidol injections can compete with it when approved and commercially supplied.
Is ISOVUE-370 safer than Omnipaque?
Both are modern low-osmolar nonionic iodinated contrast agents. Safety depends on patient factors, dose, renal function, procedure, and prior contrast reactions rather than brand identity alone.
Can ISOVUE-370 cause kidney damage?
Iodinated contrast can be associated with acute kidney injury, particularly in patients with severe renal impairment, dehydration, hemodynamic instability, or other risk factors. Risk assessment and appropriate clinical management are required before administration.[1]
Does ISOVUE-370 contain iodine that causes shellfish allergy?
Shellfish allergy does not predict an allergic reaction to iodinated contrast. The more relevant risk factor is a prior reaction to iodinated contrast media.
What is the long-term investment case for ISOVUE-370?
The product has defensive value within a mature imaging portfolio, but limited patent-driven upside. Its outlook depends on global imaging volumes, Bracco’s manufacturing and contracting position, generic penetration, and contrast-media supply conditions.
References
-
U.S. Food and Drug Administration. (2024). ISOVUE-370 (iopamidol injection) prescribing information. FDA/DailyMed.
-
National Library of Medicine. (2025). ClinicalTrials.gov search results for iopamidol and iodinated contrast media studies. ClinicalTrials.gov.
-
U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations. FDA.
-
Bracco Diagnostics Inc. (2024). ISOVUE product information. Bracco.
-
Grand View Research. (2024). Contrast media market size, share and trends analysis report. Grand View Research.
