Last updated: October 18, 2026
Optiray 160 is ioversol injection containing 160 mg of iodine per mL. Guerbet markets the Optiray franchise in the United States. The product is an older, low-concentration, nonionic iodinated contrast agent used primarily for angiographic and radiographic procedures. Its commercial value comes from recurring procedural demand and hospital formulary access, not from exclusivity pricing.
Standalone revenue for Optiray 160 is not publicly reported. Guerbet reports consolidated and business-line revenue, while Optiray sales are grouped within its contrast-media portfolio. The product has no meaningful remaining patent exclusivity, and its long-term outlook depends on procedure volumes, supply reliability, hospital contracts, and substitution by other iodinated contrast agents.
What is Optiray 160 and how is it used?
Optiray 160 is a low-osmolality, nonionic contrast medium based on ioversol. It contains 160 mg of organically bound iodine per mL and is supplied for intravascular administration.
The U.S. prescribing information identifies uses that include:
- Intra-arterial digital subtraction angiography
- Intravenous digital subtraction angiography
- Selected angiographic procedures
- Radiographic imaging where a lower iodine concentration is clinically appropriate
The product is not a therapeutic drug in the conventional sense. Its demand is linked to diagnostic and interventional imaging volumes, including angiography, vascular imaging and certain radiographic procedures. The FDA label carries the standard risks associated with iodinated contrast, including hypersensitivity reactions, contrast-associated acute kidney injury and extravasation-related injury (FDA, 2023).
Optiray 160 has a lower iodine concentration than Optiray 240, 300, 320 and 350. That concentration profile gives it a narrower commercial role than higher-strength products used in CT and advanced angiography.
Who manufactures Optiray 160?
Guerbet is the current commercial owner associated with the Optiray brand in the United States. Guerbet acquired selected contrast-media and imaging assets from Mallinckrodt in 2015, including U.S. rights associated with Optiray and related products (Guerbet, 2015).
| Item |
Detail |
| Brand |
Optiray 160 |
| Active ingredient |
Ioversol |
| Iodine concentration |
160 mg/mL |
| Drug class |
Nonionic, low-osmolality iodinated contrast medium |
| U.S. commercial company |
Guerbet LLC |
| Primary demand driver |
Angiographic and diagnostic imaging procedures |
| Prescription status |
Prescription medical product |
| Biologic |
No |
| Generic substitution potential |
High |
| Standalone revenue disclosure |
Not reported |
Guerbet’s portfolio also includes Dotarem, a gadolinium-based MRI contrast agent; Xenetix, an iodinated contrast agent in selected markets; and injection systems and related imaging products. Optiray 160 is therefore part of a broader imaging platform rather than an independently reported growth product.
What is the market size for Optiray 160?
No authoritative public source reports a separate global or U.S. market size for Optiray 160. The addressable market is the low-concentration ioversol segment within the wider iodinated contrast-media market.
Commercial demand is shaped by five factors:
- CT, angiography and interventional procedure volumes.
- Hospital purchasing contracts and group-purchasing organization decisions.
- Availability of competing agents such as iohexol, iopamidol, iodixanol, iopromide and ioversol.
- Supply-chain reliability for iodine, active pharmaceutical ingredients, vials, syringes and manufacturing capacity.
- Clinical preference for a specific concentration, viscosity and injection protocol.
Optiray 160 is more exposed to substitution than higher-concentration contrast products because many hospitals can standardize on a limited number of agents. A radiology department may use a higher-concentration product for CT and reserve 160 mg/mL ioversol for selected angiographic applications. That limits the product’s strategic importance within a hospital unless it is embedded in a specific protocol or contract.
How has the iodinated contrast market changed?
The market experienced a major supply disruption in 2022 after a shutdown at GE Healthcare’s contrast-media manufacturing facility in Shanghai. The disruption affected supplies of iohexol and iodixanol and caused hospitals to ration contrast, postpone procedures and seek alternative suppliers. The FDA and professional radiology organizations issued supply-related communications during the disruption (FDA, 2022; American College of Radiology, 2022).
The event increased the value of multi-source procurement. Hospitals expanded substitution protocols, assessed alternative contrast agents and placed greater emphasis on inventory visibility. The episode benefited suppliers with available capacity, but it also exposed the limits of rapid switching because contrast agents differ in concentration, viscosity, renal-risk protocols, injector settings and reimbursement treatment.
For Optiray 160, the disruption created temporary demand-supporting conditions. It did not create durable product exclusivity. Once supply normalized, procurement returned toward price, contract terms, clinical familiarity and supplier reliability.
What is the financial trajectory for Optiray 160?
Optiray 160 revenue is not separately disclosed by Guerbet. The most reliable financial proxy is Guerbet’s consolidated revenue and performance in contrast solutions.
| Fiscal year |
Guerbet consolidated revenue |
Commercial interpretation |
| 2022 |
Approximately €753 million |
Recovery from pandemic-related imaging disruption, with supply-chain pressure |
| 2023 |
Approximately €817 million |
Growth supported by imaging activity, pricing and portfolio performance |
| 2024 |
Approximately €842 million |
Continued growth, but not attributable specifically to Optiray 160 |
Sources report Guerbet’s 2023 revenue at approximately €817 million and 2024 revenue at approximately €842 million. These figures include the company’s full portfolio and geographic operations; they cannot be used as Optiray 160 sales (Guerbet, 2024, 2025).
The financial trajectory for Optiray 160 is likely mature rather than expansionary:
- Volume should track diagnostic and interventional imaging activity.
- Price growth is constrained by hospital procurement and generic or multisource alternatives.
- Product-level margins depend on manufacturing cost, packaging, freight and contract pricing.
- Supply disruptions can cause short-term volume gains but also increase production and logistics costs.
- The low concentration limits broad use in CT protocols where higher iodine delivery is preferred.
Optiray 160 is therefore more likely to provide stable portfolio revenue than to drive Guerbet’s growth rate. Guerbet’s strategic value is concentrated in the combined contrast portfolio, MRI agents, delivery systems and international distribution.
What companies compete with Optiray 160?
Optiray 160 competes within two overlapping markets: branded iodinated contrast and the broader hospital contrast formulary.
| Competitor |
Active ingredient |
Company |
Competitive position |
| Isovue |
Iopamidol |
Bracco |
Major nonionic iodinated contrast franchise |
| Omnipaque |
Iohexol |
GE HealthCare |
Broad CT and angiography use |
| Visipaque |
Iodixanol |
GE HealthCare |
Iso-osmolar positioning |
| Ultravist |
Iopromide |
Bayer |
Global nonionic contrast product |
| Ioversol products |
Ioversol |
Multiple manufacturers and suppliers |
Direct active-ingredient competition |
| Optiray 240/300/320/350 |
Ioversol |
Guerbet |
Same-brand concentration alternatives |
Optiray 160’s closest competitive threat is not necessarily another 160 mg/mL product. Hospitals often evaluate contrast agents by total protocol, iodine delivery, injector compatibility, adverse-event procedures, purchase price and supply security.
Branded competitors retain value through established regulatory files, manufacturing reliability, clinical familiarity and contract coverage. Those advantages do not prevent substitution when hospital systems pursue lower acquisition cost.
What is the FDA regulatory status of Optiray 160?
Optiray 160 is an FDA-approved prescription contrast product. The product is regulated as a drug rather than as a medical device, although it is administered through powered injectors and used in device-dependent imaging workflows.
The FDA labeling identifies ioversol injection concentrations and the relevant administration routes, warnings, contraindications and preparation requirements. The product is not a biologic, so biosimilar competition does not apply (FDA, 2023).
The main regulatory risks are operational and safety-related:
- Hypersensitivity reactions
- Acute kidney injury in susceptible patients
- Thyroid dysfunction in vulnerable populations
- Extravasation injury
- Administration errors involving concentration, dose or injection rate
- Manufacturing or sterility deviations
There is no meaningful regulatory exclusivity remaining for this legacy product. The original approval dates back decades, and any new-drug exclusivity associated with the original approval has expired.
What patents protect Optiray 160?
The original composition and product patents associated with ioversol and the Optiray franchise are expired or commercially ineffective as exclusivity barriers. Optiray 160 does not have a modern composition-of-matter patent position comparable to a recently launched small-molecule drug.
| IP category |
Optiray 160 position |
| Composition-of-matter patent |
Expired or no longer commercially blocking |
| Original formulation protection |
Expired |
| Method-of-use patents |
No material current exclusivity identified |
| Device or injector patents |
May apply to administration systems, not the drug itself |
| Manufacturing know-how |
Potentially relevant but not publicly equivalent to patent exclusivity |
| Orange Book value |
No significant current patent barrier identified |
| Biosimilar protection |
Not applicable |
The commercial moat is based on manufacturing, regulatory compliance, customer contracts and supply reliability. It is not based on enforceable exclusivity for the ioversol molecule.
What is the Orange Book status of Optiray 160?
The FDA Orange Book is primarily relevant to approved drug products with listed patents and generic substitution pathways. Optiray 160 does not have a publicly significant, active patent listing that would support a late-life exclusivity strategy.
The practical consequence is that a competitor does not need to wait for a listed patent expiration to enter the market. The main entry requirements are FDA approval, pharmaceutical manufacturing capability, quality compliance, commercial distribution and sufficient hospital demand.
Because contrast products are often purchased through institutional contracts, regulatory approval alone does not guarantee rapid market penetration. Hospitals may require:
- Pharmacy and therapeutics committee review
- Radiology validation
- Injector compatibility testing
- Adverse-reaction protocol updates
- Contracting and group-purchasing approval
- Assured supply volumes
Which companies are challenging Optiray 160?
No major current Paragraph IV campaign directed specifically at Optiray 160 is a central market event in the public record. Paragraph IV litigation is more common for high-value medicines with active Orange Book patents. Optiray 160 is a mature contrast product with limited patent value, making a patent challenge less economically important than ordinary generic or multisource entry.
Competitive pressure is more likely to arise through:
- Approval of an ioversol injection product
- Contract displacement by iohexol or iopamidol
- Hospital conversion to another contrast concentration
- Private-label or distributor supply arrangements
- Pricing competition after supply normalization
No material settlement agreement involving an active Optiray 160 patent estate is identified in the cited public sources.
What generic entry risks exist for Optiray 160?
Generic entry risk is high because the product is mature, the active ingredient is established and the original patent estate no longer protects the product.
The principal risks are:
- Lower unit pricing from generic ioversol products.
- Hospital conversion to competing iodinated agents.
- Loss of formulary position during contract rebidding.
- Private-label supply that weakens brand recognition.
- Procurement consolidation among large hospital systems.
- Substitution between Optiray concentrations based on injector and protocol standardization.
The risk is moderated by manufacturing complexity. Ioversol injection requires validated synthesis, control of impurities, sterile filling, container-closure integrity, validated sterilization and reliable supply of pharmaceutical-grade materials. Those requirements create an operational barrier, but not a durable patent barrier.
How strong is the Optiray 160 patent estate?
The patent estate is weak for commercial-protection purposes.
Optiray 160 has:
- No meaningful remaining molecule exclusivity.
- No disclosed current formulation patent that materially blocks competition.
- No biologic exclusivity.
- No evident patent-based settlement leverage.
- Limited ability to delay a competing ioversol product through Orange Book litigation.
Its strongest assets are non-patent rights: regulatory approvals, manufacturing records, brand recognition, customer relationships and supply history. Those assets can preserve share but generally do not support premium pricing against approved alternatives.
What generic launch scenarios are most likely?
Scenario 1: Gradual multisource erosion
A competing ioversol product gains approval and enters selected hospital accounts. Optiray 160 retains share where clinicians prefer Guerbet’s product or where contracts protect incumbent supply.
Scenario 2: Formulary displacement
A major hospital system standardizes on another contrast supplier across multiple concentrations. Optiray loses volume even without a direct 160 mg/mL substitute because the system prioritizes a single vendor.
Scenario 3: Supply-driven share gain
A competitor experiences a manufacturing disruption. Guerbet captures temporary orders, especially where Optiray is already validated in imaging protocols.
Scenario 4: Stable niche demand
Optiray 160 remains in use for specific angiographic procedures. Volume is stable, but price declines as procurement teams treat the product as a mature, substitutable input.
The fourth scenario is the most commercially plausible long-term base case. The product can remain profitable without being a growth driver.
What is the geographic coverage of Optiray 160?
Optiray availability is strongest where Guerbet has regulatory approvals, local distribution and established hospital contracts. The brand has historically had international exposure, but product names, concentrations, packaging and regulatory status vary by country.
Geographic performance depends on:
- National registration
- Local tender systems
- Hospital procurement structure
- Reimbursement for contrast agents
- Local competitors
- Import and supply-chain requirements
- Availability of alternative iodinated agents
The U.S. market is strategically important because of its procedure volume and hospital purchasing scale. Europe and other markets may show different demand patterns because centralized tenders place greater emphasis on price and supply guarantees.
What is the investment and commercial outlook?
Optiray 160 is best viewed as a mature, cash-generating contrast product with limited standalone growth potential. Its financial sensitivity is operational rather than intellectual-property driven.
| Factor |
Outlook |
| Demand |
Stable to modestly growing with imaging volumes |
| Pricing |
Downward pressure from mature competition |
| Patent protection |
Minimal |
| Regulatory risk |
Low for an established product, subject to manufacturing compliance |
| Supply-chain risk |
Material |
| Generic risk |
High |
| Revenue visibility |
Moderate at portfolio level, low at product level |
| Strategic value |
Supports Guerbet’s broader imaging franchise |
| Standalone growth potential |
Limited |
Optiray 160 can contribute recurring revenue, but it is unlikely to materially change Guerbet’s consolidated trajectory. The more important financial variables are Guerbet’s total contrast portfolio, Dotarem performance, international expansion, imaging procedure volumes, pricing, production capacity and hospital contract retention.
Key Takeaways
- Optiray 160 is ioversol injection at 160 mg iodine per mL.
- Guerbet is the relevant U.S. commercial owner after acquiring selected Mallinckrodt contrast assets.
- Standalone Optiray 160 revenue is not publicly disclosed.
- Guerbet’s consolidated revenue increased from approximately €753 million in 2022 to €817 million in 2023 and €842 million in 2024, but those figures do not isolate Optiray 160.
- The product has no meaningful remaining patent exclusivity.
- Orange Book and Paragraph IV litigation are not central commercial barriers for this mature product.
- Generic and multisource competition is the primary long-term risk.
- Supply reliability, hospital contracting and protocol-specific use are more important than patent protection.
- The likely trajectory is stable or gradually declining product economics within a growing broader imaging portfolio.
FAQs
Is Optiray 160 the same as ioversol?
Yes. Optiray 160 is a branded ioversol injection containing 160 mg of iodine per mL.
Can Optiray 160 be substituted with Omnipaque?
Substitution may be clinically possible, but the products contain different active ingredients and concentrations. The change requires review of imaging protocols, dosing, injector settings, renal-risk procedures and hospital approval.
Does Optiray 160 have biosimilar competition?
No. Optiray 160 is a nonbiologic small-molecule contrast product. Biosimilar rules do not apply.
Is Optiray 160 still commercially important to Guerbet?
It is relevant as part of Guerbet’s established contrast portfolio, but it is unlikely to be a major standalone growth driver because it is mature and subject to multisource competition.
Could Optiray 160 sales increase during a contrast shortage?
Yes. Temporary supply shortages affecting competing products can increase demand for Optiray 160. Such gains are generally dependent on available inventory, regulatory supply capacity and hospital protocol validation.
References
-
American College of Radiology. (2022). Iodinated contrast media shortage: Information and recommendations. https://www.acr.org/Clinical-Resources/Contrast-Manual
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European Medicines Agency. (n.d.). Ioversol and iodinated contrast media product information. https://www.ema.europa.eu/
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U.S. Food and Drug Administration. (2022). FDA drug shortages: Iodinated contrast media. https://www.accessdata.fda.gov/scripts/drugshortages/
-
U.S. Food and Drug Administration. (2023). Optiray 160 prescribing information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/
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Guerbet. (2015). Guerbet acquires selected contrast media and imaging assets from Mallinckrodt. https://www.guerbet.com/
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Guerbet. (2024). 2023 annual financial results. https://www.guerbet.com/investors/
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Guerbet. (2025). 2024 annual financial results. https://www.guerbet.com/investors/
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U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
