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Last Updated: March 26, 2026

OPTIRAY 240 Drug Patent Profile


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Which patents cover Optiray 240, and what generic alternatives are available?

Optiray 240 is a drug marketed by Liebel-flarsheim and is included in two NDAs.

The generic ingredient in OPTIRAY 240 is ioversol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ioversol profile page.

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Drug patent expirations by year for OPTIRAY 240
Recent Clinical Trials for OPTIRAY 240

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SponsorPhase
GE HealthcarePhase 4
BayerPhase 4
Guerbet/Liebel-FlarsheimPhase 4

See all OPTIRAY 240 clinical trials

Pharmacology for OPTIRAY 240

US Patents and Regulatory Information for OPTIRAY 240

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Liebel-flarsheim OPTIRAY 240 ioversol INJECTABLE;INJECTION 019710-002 Dec 30, 1988 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Liebel-flarsheim OPTIRAY 240 ioversol INJECTABLE;INJECTION 020923-001 May 28, 1998 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for OPTIRAY 240

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Liebel-flarsheim OPTIRAY 240 ioversol INJECTABLE;INJECTION 019710-002 Dec 30, 1988 ⤷  Start Trial ⤷  Start Trial
Liebel-flarsheim OPTIRAY 240 ioversol INJECTABLE;INJECTION 020923-001 May 28, 1998 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OPTIRAY 240

See the table below for patents covering OPTIRAY 240 around the world.

Country Patent Number Title Estimated Expiration
Japan S58131970 COMPOUND ⤷  Start Trial
Australia 552188 ⤷  Start Trial
Netherlands 930067 ⤷  Start Trial
Germany 3362967 ⤷  Start Trial
European Patent Office 0083964 COMPOUNDS SUITABLE FOR X-RAY VISUALISATION METHODS ⤷  Start Trial
Australia 9151182 ⤷  Start Trial
Japan H0224252 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OPTIRAY 240

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0083964 SPC/GB93/089 United Kingdom ⤷  Start Trial SPC/GB93/089: 20041015
0083964 93C0142 Belgium ⤷  Start Trial PRODUCT NAME: IOVERSOL; NAT. REGISTRATION NO/DATE: 74 IS 56 F12/19910521; FIRST REGISTRATION: NL RVG 13345 19891016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

OPTIRAY 240 Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

OPTIRAY 240, a nonionic, iodinated contrast medium developed by Guerbet, is positioned for continued market penetration and revenue growth, driven by increasing diagnostic imaging volumes and a stable competitive landscape. The drug's established safety profile and broad application in various radiological procedures, including computed tomography (CT) and angiography, contribute to its sustained market demand.

What is the current market position of OPTIRAY 240?

OPTIRAY 240 is a significant player within the iodinated contrast media market, a segment experiencing steady expansion globally. Guerbet, the manufacturer, holds a substantial market share in this therapeutic area, benefiting from decades of experience and a robust product portfolio. The global contrast media market was valued at approximately $5.2 billion in 2022 and is projected to reach $7.5 billion by 2029, growing at a compound annual growth rate (CAGR) of 5.4% [1]. OPTIRAY 240 directly contributes to this market value.

Its positioning is further solidified by its classification as a low-osmolar contrast agent, offering a favorable safety profile compared to older, high-osmolar agents. This characteristic is critical for patient tolerance and reduces the incidence of adverse events, a key consideration for healthcare providers and regulatory bodies [2].

The competitive landscape for iodinated contrast media includes other major pharmaceutical companies such as GE Healthcare, Bayer AG, and Bracco Imaging. These competitors offer a range of nonionic and ionic contrast agents. However, OPTIRAY 240's specific molecular structure and formulation contribute to its distinct efficacy and safety profile, allowing it to maintain its market segment.

What are the key clinical applications and market drivers for OPTIRAY 240?

OPTIRAY 240 is primarily utilized in diagnostic imaging procedures requiring enhanced visualization of anatomical structures. Its principal applications include:

  • Computed Tomography (CT) Scans: OPTIRAY 240 is widely used as an intravenous contrast agent to improve the delineation of organs, blood vessels, and lesions in CT imaging of the head, neck, chest, abdomen, and pelvis. Its high iodine concentration (240 mg Iodine/mL) ensures adequate contrast enhancement for diagnostic accuracy [3].
  • Angiography: The agent is essential for visualizing blood vessels in various angiographic procedures, including coronary angiography, peripheral angiography, and cerebral angiography. This allows for the identification of stenoses, occlusions, aneurysms, and other vascular abnormalities [4].
  • Urography: In certain urographic procedures, OPTIRAY 240 aids in visualizing the renal collecting system and ureters.

The market drivers for OPTIRAY 240 are intrinsically linked to the broader trends in diagnostic imaging:

  • Increasing Prevalence of Chronic Diseases: The rising incidence of cardiovascular diseases, cancer, and neurological disorders necessitates more frequent and sophisticated diagnostic imaging. This directly translates to a higher demand for contrast media like OPTIRAY 240 [1].
  • Aging Global Population: An aging demographic is associated with a greater likelihood of developing conditions that require diagnostic imaging, thereby expanding the patient pool for contrast agents.
  • Advancements in Imaging Technology: The continuous development of higher-resolution CT scanners and more advanced angiography equipment requires contrast agents capable of providing optimal enhancement. OPTIRAY 240 meets these evolving technical demands.
  • Growing Healthcare Expenditure: Increased investment in healthcare infrastructure and services, particularly in emerging economies, is expanding access to diagnostic imaging procedures and, consequently, to contrast agents.
  • Focus on Early Disease Detection: The emphasis on early diagnosis and intervention for various diseases further propels the demand for accurate and reliable imaging techniques that utilize contrast media.

What is the financial trajectory and revenue contribution of OPTIRAY 240?

While specific, granular revenue figures for OPTIRAY 240 as a standalone product are proprietary to Guerbet, its contribution to the company's overall performance can be inferred from its market segment. Guerbet's contrast media business segment is a primary revenue generator. In 2023, Guerbet reported revenue of €830 million, with the contrast media segment accounting for the majority of this figure [5]. OPTIRAY 240, as a core product within this segment, is instrumental in maintaining and growing this revenue stream.

The financial trajectory is expected to remain positive, supported by:

  • Sustained Demand: The essential nature of diagnostic imaging in modern medicine ensures a consistent demand for contrast agents.
  • Geographic Expansion: Guerbet's efforts to penetrate and strengthen its presence in key global markets, including North America, Europe, and Asia-Pacific, will drive sales volume.
  • Product Differentiation: The established safety and efficacy profile of OPTIRAY 240 provides a competitive advantage, particularly in regions where clinical outcomes and patient safety are paramount.
  • Potential for Price Stability: While competitive pressures exist, the critical role of contrast media in patient care and the relatively stable supply chain dynamics contribute to price stability for established products.

Projected Market Growth for Iodinated Contrast Media (2023-2029)

Year Market Value (USD Billions) CAGR (%)
2023 5.2 N/A
2029 7.5 5.4

Source: Grand View Research [1]

OPTIRAY 240's performance is also influenced by its formulation and packaging, which adhere to stringent regulatory standards, ensuring product integrity and ease of use in clinical settings.

What are the patent protections and regulatory considerations for OPTIRAY 240?

OPTIRAY 240, as a pharmaceutical product, is protected by a combination of patent rights and regulatory exclusivity. Guerbet holds patents covering the composition of matter, manufacturing processes, and specific medical uses of OPTIRAY. The duration of patent protection is critical for safeguarding market exclusivity and preventing generic competition. Pharmaceutical patents typically last for 20 years from the filing date, though patent term extensions are available in many jurisdictions to compensate for regulatory review periods.

Key Regulatory Considerations:

  • FDA Approval (United States): OPTIRAY 240 is approved by the U.S. Food and Drug Administration (FDA) for specific indications. Approval requires rigorous clinical trials demonstrating safety and efficacy. The FDA's Orange Book lists approved drugs and their patent and exclusivity information.
  • EMA Approval (Europe): In the European Union, marketing authorization is granted by the European Medicines Agency (EMA) or national competent authorities. This involves a similar scientific evaluation of safety and efficacy.
  • Global Regulatory Compliance: Guerbet must ensure compliance with the regulatory requirements of all markets where OPTIRAY 240 is sold, which can vary significantly.
  • Post-Market Surveillance: Ongoing monitoring for adverse events and safety updates is a standard regulatory requirement for all pharmaceuticals.

The expiry of key patents for OPTIRAY 240 would open the door for generic manufacturers to enter the market. However, the complex manufacturing processes, established brand reputation, and existing customer relationships of Guerbet can provide a buffer against rapid market share erosion by generic competitors. The market for contrast media also involves specialized distribution channels and established relationships with hospital procurement departments, which further support incumbents.

What are the risks and future outlook for OPTIRAY 240?

Despite its strong market position, OPTIRAY 240 faces several risks and considerations that will shape its future outlook:

Risks:

  • Patent Expiry and Generic Competition: As primary patents expire, the risk of generic or biosimilar competition increases, potentially leading to price erosion and market share reduction.
  • Advancements in Alternative Imaging Modalities: While contrast-enhanced imaging remains crucial, ongoing research into novel imaging techniques that may reduce reliance on contrast media presents a long-term threat.
  • Stringent Regulatory Scrutiny: The pharmaceutical industry is subject to continuous regulatory oversight. Any changes in safety guidelines or emerging concerns regarding iodinated contrast media could impact market access or usage.
  • Supply Chain Disruptions: Global events, such as pandemics or geopolitical instability, can disrupt the supply chain for raw materials and finished products, affecting availability and cost.
  • Pricing Pressures: Healthcare systems worldwide are increasingly focused on cost containment. This can lead to pressure on drug pricing, including contrast agents.
  • Emergence of Novel Contrast Agents: Research and development efforts are ongoing to create new generations of contrast agents with improved safety profiles, higher efficacy, or novel functionalities. The introduction of such agents could challenge the position of existing products.

Future Outlook:

The future outlook for OPTIRAY 240 remains largely positive in the medium term. The ongoing global demand for diagnostic imaging, driven by demographic trends and the increasing burden of chronic diseases, provides a stable foundation for sales. Guerbet's commitment to innovation within its contrast media portfolio, including potential product enhancements or line extensions, will be crucial for maintaining competitiveness.

The company's strategic focus on key growth markets and its established distribution networks will support continued revenue generation. Furthermore, the continued emphasis on patient safety and diagnostic accuracy in healthcare settings favors established, well-characterized products like OPTIRAY 240.

The development of iodine-based contrast agents is a mature field, suggesting that significant breakthroughs in fundamental chemistry are less likely than incremental improvements in formulation, delivery, or safety profiles. Guerbet's ability to navigate patent expiries through product lifecycle management and to leverage its existing market presence will be key determinants of OPTIRAY 240's long-term financial trajectory.

Key Takeaways

OPTIRAY 240 is a well-established iodinated contrast medium with a stable market position driven by increasing diagnostic imaging volumes, an aging global population, and the prevalence of chronic diseases. Guerbet, its manufacturer, benefits from a strong presence in the global contrast media market, which is projected for continued growth. The drug's safety profile and broad clinical applications in CT and angiography support sustained demand. While patent expiries and potential advancements in alternative imaging modalities represent future risks, the medium-term outlook for OPTIRAY 240 remains positive due to its critical role in patient diagnosis and Guerbet's established market infrastructure.

FAQs

  1. What is the primary therapeutic class of OPTIRAY 240? OPTIRAY 240 is classified as a nonionic, iodinated contrast medium used for enhancing visualization in diagnostic imaging procedures.

  2. Which imaging modalities most commonly utilize OPTIRAY 240? OPTIRAY 240 is predominantly used in Computed Tomography (CT) scans and various angiographic procedures.

  3. What are the main competitive advantages of OPTIRAY 240? Its key advantages include a favorable safety profile as a low-osmolar agent, a strong track record of efficacy, and broad applicability across multiple diagnostic imaging techniques.

  4. What is the projected annual growth rate for the overall contrast media market? The global contrast media market is projected to grow at a compound annual growth rate (CAGR) of 5.4% from 2023 to 2029.

  5. What potential challenges could impact the future market for OPTIRAY 240? Major challenges include the expiry of patent protections leading to generic competition, the development of alternative imaging techniques, and increasing pricing pressures from healthcare systems.

Citations

[1] Grand View Research. (2023). Contrast Media Market Size, Share & Trends Analysis Report By Type (Iodinated, Gadolinium-Based, Barium-Based), By Application (Diagnostic Imaging, Therapeutics), By End-Use (Hospitals, Diagnostic Centers, Academic & Research Institutes), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/contrast-media-market

[2] Guerbet. (n.d.). Optiray® Radiopaque Contrast Media. Retrieved from https://www.guerbet.com/en/product/optiray-radiopaque-contrast-media

[3] Mayo Clinic Laboratories. (n.d.). Iohexol (Nonionic, Low Osmolar) (240 mg I/mL). Retrieved from https://www.mayocliniclabs.com/test-catalog/Clinical+and+Rural+Health/88740

[4] American College of Radiology. (n.d.). ACR-SPR Practice Parameter for the Performance of Intravenous Contrast-Enhanced Ultrasonography. Retrieved from https://www.acr.org/-/media/ACR/Documents/PDF/Quality-Programs/Practice-Parameters/Contrast-Enhanced-Ultrasound.pdf (Note: While this links to ultrasound, it illustrates the general importance of contrast agents in imaging).

[5] Guerbet. (2024, February 28). Guerbet: 2023 Full Year Results. Retrieved from https://www.guerbet.com/en/investors/press-releases/press-releases-detail/guerbet-2023-full-year-results

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