Last updated: November 4, 2026
Optiray 350 is a mature, nonionic, low-osmolar iodinated contrast agent containing ioversol at 350 mg iodine/mL. Its commercial value is driven by hospital procurement, supply reliability, contract pricing, and Guerbet’s broader contrast-media portfolio rather than patent exclusivity. U.S. product-specific revenue is not publicly reported. Generic and therapeutic-substitute pressure is persistent, but manufacturing, regulatory, quality, and supply-chain requirements limit rapid market displacement.
Optiray 350 Market Dynamics, Financial Trajectory, and Patent Outlook
What is Optiray 350 and who markets it?
Optiray 350 is an injectable radiographic contrast medium containing ioversol. The product is used primarily for contrast-enhanced computed tomography, angiography, intravenous digital subtraction angiography, and other approved imaging procedures.
| Attribute |
Optiray 350 |
| Active ingredient |
Ioversol |
| Concentration |
350 mg iodine/mL |
| Dosage form |
Sterile injectable solution |
| Drug class |
Nonionic, low-osmolar iodinated contrast agent |
| U.S. regulatory application |
NDA 018735 |
| U.S. marketing organization |
Guerbet affiliate, historically Liebel-Flarsheim |
| Primary customers |
Hospitals, imaging centers, radiology departments, group purchasing organizations |
| Commercial category |
Mature branded contrast medium |
| Biosimilar exposure |
None |
| Core competitive products |
Omnipaque, Isovue, Visipaque, Ultravist |
Optiray 350 is part of Guerbet’s broader imaging franchise, which includes iodinated contrast agents, gadolinium-based contrast agents, and injection systems. Guerbet acquired Mallinckrodt’s contrast-media and delivery-systems business in 2015, including the Liebel-Flarsheim portfolio associated with Optiray in the United States (Guerbet, 2015).
What is the FDA regulatory status of Optiray 350?
Optiray 350 is an FDA-approved prescription product marketed under an established new drug application. Its regulatory position is mature rather than exclusivity-driven.
The product’s commercial status reflects several characteristics:
- It has a long-established FDA approval history.
- It is not a biologic and does not face a biosimilar pathway.
- Its active ingredient, ioversol, is an established small molecule.
- Product availability depends on NDA manufacturing controls, sterile-fill capacity, quality systems, and supply continuity.
- The FDA label identifies contraindications, warnings concerning hypersensitivity and renal risk, and administration requirements applicable to iodinated contrast media (U.S. Food and Drug Administration, n.d.-a).
Unlike newer specialty drugs, Optiray 350 does not depend on regulatory exclusivity to sustain demand. Hospitals select it based on clinical familiarity, formulary position, price, distributor availability, and contract terms.
What patents protect Optiray 350?
Optiray 350 has no evident commercially meaningful active U.S. composition-of-matter patent protection. The relevant ioversol and contrast-agent patent families are from the early development era of nonionic iodinated contrast media, making their ordinary patent terms long expired.
| Protection category |
Current commercial effect |
| Ioversol composition patents |
Expired |
| Early manufacturing patents |
Expired or commercially weak |
| Core diagnostic-use patents |
Expired |
| Product-specific formulation patents |
No material active protection identified |
| Method-of-use patents |
No material barrier identified for routine approved imaging uses |
| Regulatory exclusivity |
Not a current commercial barrier |
| Trade secrets and manufacturing know-how |
Potentially relevant |
| Sterile manufacturing capacity |
Material operational barrier |
The remaining defensibility is operational. Ioversol production requires controlled raw materials, validated synthesis, impurity control, sterile manufacturing, container-closure testing, and regulatory consistency. These factors can deter small entrants even when patent barriers are absent.
When did Optiray 350 lose exclusivity?
Optiray 350’s meaningful market exclusivity ended many years ago. The product does not depend on a current Orange Book patent term or pediatric exclusivity period for its commercial position.
A precise original patent-expiration date for every historical ioversol patent is not commercially necessary because the relevant patent families expired well before the current market period. The product’s present competitive position is based on brand continuity and supply execution.
What is the Orange Book status of Optiray 350?
The Orange Book is relevant to Optiray 350 as an FDA-approved NDA product, but it is not the principal source of current competitive protection. No active patent barrier comparable to those protecting newer small-molecule medicines is central to the product’s market position.
The practical Orange Book implications are:
- An ANDA applicant may seek approval for a therapeutically equivalent ioversol injection if it satisfies FDA requirements.
- A Paragraph IV certification could be used if an applicant identified a listed patent, although no active patent campaign is central to Optiray 350’s market.
- Patent expiry does not automatically create immediate substitution because hospitals and distributors also evaluate supply capacity, packaging, pricing, and procurement contracts.
- The market can face competition from both generic ioversol products and branded alternative contrast agents.
The relevant approval pathway is therefore more important than patent litigation. FDA requirements for pharmaceutical equivalence, sterility, stability, labeling, and manufacturing remain significant.
Are there Paragraph IV challenges to Optiray 350?
No material, active Paragraph IV litigation campaign against Optiray 350 is evident from the public commercial record used for this analysis. That does not eliminate generic-entry risk. It indicates that the principal competitive issue is likely ANDA approval and commercial supply rather than a high-value patent dispute.
For a mature injectable contrast product, an ANDA applicant can face several business constraints:
- Establishing a reliable supply of ioversol.
- Matching the reference product’s concentration and dosage form.
- Demonstrating pharmaceutical equivalence.
- Validating sterile manufacturing.
- Securing packaging and vial capacity.
- Building hospital and distributor contracts.
- Managing shortages or manufacturing interruptions.
A successful ANDA entrant would more likely compete through price and contract access than through a litigation-led launch strategy.
What formulations are protected by Optiray 350?
Optiray 350 is a ready-to-use aqueous injection containing ioversol at 350 mg iodine/mL. The formulation’s commercial value is tied to product consistency, injection performance, osmolality, viscosity, sterility, container compatibility, and shelf life.
The principal formulation characteristics include:
- Single-use injectable presentation.
- High iodine concentration suitable for enhanced imaging.
- Nonionic low-osmolar profile.
- Packaging designed for hospital and imaging-center administration.
- Compatibility with power-injection workflows, subject to approved administration parameters.
No active formulation patent is publicly central to the product’s current commercial position. Formulation know-how still has operational value because contrast agents are sterile injectable products and manufacturing deviations can lead to regulatory action, recalls, or supply disruption.
How does Optiray 350 compare with competing contrast agents?
Optiray 350 competes in a mature market with products that offer similar clinical utility. The main differentiation is not a unique mechanism of action. It is procurement economics, local formulary status, physician familiarity, supply reliability, and portfolio contracting.
| Product |
Active ingredient |
Typical competitive position |
| Optiray 350 |
Ioversol |
Established low-osmolar alternative |
| Omnipaque |
Iohexol |
Broadly used, strong institutional presence |
| Isovue |
Iopamidol |
Established branded competitor |
| Visipaque |
Iodixanol |
Iso-osmolar positioning, often higher cost |
| Ultravist |
Iopromide |
Established nonionic iodinated contrast agent |
Optiray 350 may compete effectively when Guerbet can provide reliable supply and competitive contract economics. It faces pressure when hospitals consolidate contrast purchases across a single manufacturer or favor products with broader concentration and presentation portfolios.
How does Optiray 350 compare with Visipaque?
Visipaque contains iodixanol and is generally positioned as an iso-osmolar contrast agent. Optiray 350 is a low-osmolar ioversol product. The choice depends on clinical protocol, patient risk assessment, institutional preference, and cost.
Visipaque may command a premium in settings where iso-osmolar positioning is valued. Optiray 350 benefits from the lower cost structure and familiarity associated with established low-osmolar contrast products.
How does Optiray 350 compare with Omnipaque?
Omnipaque, containing iohexol, is one of the strongest commercial comparators. Both products are used across routine and advanced imaging procedures. Competition is often determined by hospital-wide contracts, injector compatibility, distributor arrangements, and shortage management rather than major differences in routine clinical utility.
What is the financial trajectory of Optiray 350?
Optiray 350’s standalone revenue and profit are not separately disclosed in Guerbet’s public financial reporting. The product is reported within broader contrast-media and imaging segments. A defensible product-level revenue estimate cannot be derived from public filings without proprietary sales data.
The financial trajectory is therefore best assessed qualitatively:
| Period |
Commercial trajectory |
| Launch and expansion |
Growth from adoption of nonionic iodinated contrast imaging |
| Mature branded period |
Stable demand with price and contract pressure |
| Post-patent period |
Reduced exclusivity, greater substitution risk |
| Guerbet ownership period |
Portfolio integration and supply-chain optimization |
| Current mature period |
Volume resilience, limited pricing power, tender-driven economics |
Revenue is likely influenced by five variables:
- Imaging procedure volumes.
- Hospital and outpatient imaging demand.
- Contract wins and losses.
- Product availability and manufacturing continuity.
- Price erosion from alternative brands and generic entrants.
The product should be treated as a mature cash-generation asset rather than a growth pharmaceutical. Its value is more likely reflected in portfolio retention, manufacturing utilization, and customer relationships than in standalone price expansion.
What market dynamics affect Optiray 350 sales?
Hospital procurement and group purchasing
Large hospitals and integrated delivery networks frequently procure contrast media through competitive tenders or group purchasing organizations. Contract awards can shift volume among products with limited clinical differentiation.
A supplier with a broad portfolio can use contrast agents, injectors, service agreements, and supply guarantees to improve account retention. This favors Guerbet as a portfolio supplier but also exposes Optiray 350 to bundled-contract competition.
Supply shortages and manufacturing concentration
Sterile injectable products are exposed to manufacturing interruptions, raw-material shortages, quality events, and logistics failures. Contrast-media shortages can temporarily increase demand for available products, but the benefit may be constrained by production capacity.
During shortage conditions, hospitals may qualify substitute products quickly, which can create both temporary volume opportunities and permanent formulary switching.
Outpatient imaging growth
Growth in outpatient imaging supports contrast-media demand, particularly for CT and vascular imaging. The market remains tied to procedure volumes rather than innovation cycles. Volume can be affected by reimbursement, radiology capacity, deferred procedures, and broader healthcare utilization.
Price erosion
Without meaningful patent protection, price increases are difficult to sustain. Price pressure is strongest in large hospital tenders and where multiple suppliers can meet technical and regulatory requirements.
What generic entry risks exist for Optiray 350?
Generic-entry risk is structurally high because the product is mature and lacks meaningful patent exclusivity. The actual pace of erosion depends on the number of approved suppliers and their manufacturing capacity.
| Risk |
Effect on Optiray 350 |
| Generic ioversol approval |
Direct price and volume pressure |
| Alternative branded agents |
Substitution in tenders |
| Hospital consolidation |
Greater buyer negotiating power |
| Supply interruption |
Potential volume loss or temporary gain |
| Regulatory manufacturing event |
High risk because the product is injectable |
| Portfolio contract loss |
Rapid account-level displacement |
| Limited product differentiation |
Weak pricing leverage |
Generic entrants may not immediately capture the market if they cannot guarantee supply at scale. In contrast media, hospitals may retain an established supplier when the price difference is modest and the operational cost of switching is high.
Which companies compete with or challenge Optiray 350?
The competitive field includes:
- GE HealthCare, through Omnipaque and related imaging products.
- Bracco, through Isovue and other contrast agents.
- Bayer, through Ultravist and broader radiology products.
- Guerbet, through Optiray, other contrast agents, and injection systems.
- Potential generic manufacturers of ioversol or equivalent iodinated contrast products.
Competition occurs at the account and contract level. There is no single competitor that must defeat Optiray 350 clinically to take share. A rival can gain volume through a lower bid, stronger supply guarantee, broader product coverage, or a hospital-wide equipment arrangement.
What patent litigation affects Optiray 350?
No high-value, active patent litigation is central to Optiray 350’s current commercial profile. The more relevant legal risks are:
- Product liability claims.
- Manufacturing and quality disputes.
- Contract disputes with hospitals or distributors.
- Regulatory actions involving sterile production.
- Trade-secret or supply agreements involving manufacturing partners.
The absence of a major patent dispute reduces litigation uncertainty but also confirms that the product has limited legal protection against substitution.
What licensing deals affect Optiray 350?
The material ownership transaction was Guerbet’s 2015 acquisition of Mallinckrodt’s contrast-media and delivery-systems business. The transaction transferred relevant commercial assets and strengthened Guerbet’s position in contrast media and injection systems (Guerbet, 2015).
No separate current licensing arrangement is publicly central to Optiray 350’s revenue outlook. Its economics are more likely governed by internal manufacturing, distribution, tender, and supply agreements than by royalty-bearing patent licenses.
What is the geographic coverage of Optiray 350?
Optiray products have been commercialized in multiple markets, but product names, concentrations, regulatory approvals, packaging, and marketing rights vary by jurisdiction. The United States is commercially important because of its large imaging market and established hospital procurement structure.
Geographic performance depends on:
- National approval status.
- Local reimbursement and procurement rules.
- Distributor arrangements.
- Availability of competing iodinated agents.
- Manufacturing and import requirements.
- Local tender outcomes.
The same product may have different competitive positions across the United States, Europe, and other markets because hospital purchasing systems and contrast-media portfolios differ.
How strong is the Optiray 350 patent estate?
The patent estate is weak as a current exclusivity asset and moderate as an operational asset.
| Dimension |
Assessment |
| Composition-of-matter protection |
Expired |
| Formulation protection |
Limited current relevance |
| Method-of-use protection |
No meaningful current barrier |
| Orange Book leverage |
Low |
| Generic vulnerability |
High |
| Manufacturing complexity |
Moderate to high |
| Brand and formulary persistence |
Moderate |
| Supply-chain defensibility |
Potentially meaningful |
| Litigation protection |
Low |
Optiray 350 is commercially defensible through execution, not patents. The strongest assets are validated manufacturing, regulatory history, hospital relationships, supply reliability, and integration with Guerbet’s imaging portfolio.
Key Takeaways
- Optiray 350 is a mature ioversol-based iodinated contrast agent marketed within Guerbet’s imaging portfolio.
- The product has no meaningful current patent exclusivity based on the long-expired ioversol patent landscape.
- FDA approval is maintained under NDA 018735, but regulatory status does not provide a modern exclusivity advantage.
- Standalone Optiray 350 revenue is not publicly disclosed.
- Financial performance is driven by imaging volumes, hospital tenders, price competition, supply continuity, and portfolio contracting.
- Generic and branded-substitute risk is high, although sterile manufacturing and supply requirements can slow market displacement.
- No major active Paragraph IV or patent-litigation campaign is central to the product’s commercial outlook.
- The most important barriers are manufacturing quality, sterile capacity, hospital contracts, and supply reliability.
FAQs
Is Optiray 350 a generic or branded drug?
Optiray 350 is a branded product containing the established active ingredient ioversol. It competes with other branded contrast agents and may face generic ioversol competition.
Does Optiray 350 still have patent protection?
No commercially meaningful active patent protection is central to Optiray 350. The relevant early ioversol and contrast-agent patent families expired long ago.
Who manufactures Optiray 350?
Optiray 350 is associated with Guerbet’s U.S. contrast-media business and the Liebel-Flarsheim manufacturing organization identified in U.S. product labeling.
Is Optiray 350 at risk from biosimilars?
No. Optiray 350 is a small-molecule injectable contrast agent, not a biologic. Its relevant competitive risk comes from generics and alternative iodinated contrast agents.
What determines the future revenue of Optiray 350?
Future revenue depends mainly on CT and angiography procedure volumes, hospital contract retention, pricing, supply reliability, manufacturing capacity, and competition from Omnipaque, Isovue, Visipaque, Ultravist, and generic products.
References
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Guerbet. (2015). Guerbet acquires Mallinckrodt’s contrast media and delivery systems business. Guerbet.
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U.S. Food and Drug Administration. (n.d.-a). Optiray 350 (ioversol) injection: Prescribing information. FDA.
-
U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations. FDA.
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U.S. Food and Drug Administration. (n.d.-c). Drug shortages: Iodinated contrast media. FDA.
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Guerbet. (2023). Universal registration document and annual financial report. Guerbet.
