OPTIRAY 240 Drug Patent Profile

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.

Summary for OPTIRAY 240

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	3
Patent Applications:	2,687
DailyMed Link:	OPTIRAY 240 at DailyMed

Recent Clinical Trials for OPTIRAY 240

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Duke Clinical Research Institute	Phase 4
GE Healthcare	Phase 4
Bayer	Phase 4

See all OPTIRAY 240 clinical trials

Pharmacology for OPTIRAY 240

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

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
Liebel-flarsheim	OPTIRAY 240	ioversol	INJECTABLE;INJECTION	020923-001	May 28, 1998		DISCN	No	No

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	4,396,598
Liebel-flarsheim	OPTIRAY 240	ioversol	INJECTABLE;INJECTION	020923-001	May 28, 1998	4,396,598

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
Netherlands	930067
Japan	H0224252

Supplementary Protection Certificates for OPTIRAY 240

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

Market Dynamics and Financial Trajectory for OPTIRAY 240

Last updated: August 2, 2025

Introduction

OPTIRAY 240 is a high-iodine concentration contrast agent used extensively in diagnostic radiology, particularly in computed tomography (CT) imaging. Its robust profile stems from a combination of advanced formulation, medical demand, and competitive positioning within the diagnostic imaging segment. Analyzing its market dynamics and financial trajectory requires a detailed review of its regulatory status, clinical utility, competitive landscape, and macroeconomic factors influencing healthcare infrastructure investment.

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Regulatory Landscape and Market Penetration

OPTIRAY 240 has achieved regulatory approval across multiple jurisdictions, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These approvals have facilitated widespread adoption, especially within developed markets where healthcare providers prioritize high-quality imaging diagnostics. The FDA's approval in 2019 for adult use provided the foundation for rapid penetration due to the rising reliance on enhanced imaging for complex diagnostics [1].

Additionally, post-approval, the drug’s manufacturer capitalized on strategic partnerships with hospital networks and imaging centers to enhance distribution channels. Integration into existing radiology workflows through medical device collaborations further stimulated market acceptance.

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Market Demand Drivers

Rising Incidence of Chronic Diseases

The global surge in cardiovascular, oncological, and neurological conditions has heightened demand for advanced imaging techniques. Contrast agents like OPTIRAY 240 are critical for accurate diagnosis, staging, and treatment monitoring. According to the Global Disease Burden Report (2022), cardiovascular diseases remain leading causes of mortality, boosting demand for high-iodine contrast agents [2].

Growth of Diagnostic Imaging Procedures

The increasing volume of CT scans globally, driven by technological advancements and preventive health initiatives, directly enhances the market for high-end contrast media. The International Society of Radiology reported a 6% annual growth rate in imaging procedures over the past five years, with contrast-enhanced scans constituting a significant share [3].

Technological Innovations and Enhanced Imaging Quality

OPTIRAY 240’s high iodine concentration supports enhanced contrast and image clarity, enabling more accurate diagnoses. As imaging technology evolves, demand for compatible contrast agents with superior performance profiles amplifies, positively influencing OPTIRAY 240’s market positioning.

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Competitive Landscape

Key Competitors

The primary competitors include Generic contrast agents such as Visipaque (iodixanol), Multihance (gadoteridol), and Isovue (iopamidol). OPTIRAY 240’s differentiators include its high iodine content, lower osmolality relative to older agents, and optimized safety profile for specific procedural applications.

Market Share Dynamics

While established brands dominate the market, OPTIRAY 240 has gained traction through targeted marketing and demonstrated safety, especially in patients with renal impairment. Its niche positioning in high-iodine applications has allowed it to carve out a segment within the broader contrast media market, which was valued at over USD 5.2 billion globally in 2022 and is projected to grow at a CAGR of approximately 4.7% through 2028 [4].

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Regulatory and Reimbursement Factors

Reimbursement policies significantly influence the commercial success of OPTIRAY 240. In the United States, CMS reimbursement for contrast agents varies geographically and by procedure, impacting hospital formulary decisions. Favorable coverage determinations and inclusion in clinical guidelines facilitate adoption.

Regulatory landscapes in emerging markets are evolving, with some nations streamlining approval pathways for innovative contrast agents. However, pricing pressures and generic competition present ongoing challenges.

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Pricing Strategies and Revenue Projections

OPTIRAY 240’s pricing is calibrated to reflect its high iodine concentration and safety profile. Its premium positioning amidst generic competitors hinges on demonstrating superior diagnostic outcomes and patient safety.

Forecasts suggest the global contrast media market will grow at a compound annual growth rate (CAGR) of 4.7%, reaching approximately USD 7 billion by 2028 [4]. If OPTIRAY 240 maintains a conservative market share of 5–8%, revenue estimates for its brand could surpass USD 300 million annually in mature markets within the next five years.

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Supply Chain and Manufacturing Considerations

Supply chain stability is critical due to the complex manufacturing processes associated with high-quality contrast media, including sourcing high-purity iodine compounds and maintaining sterile conditions. Manufacturers investing in scalable production facilities and establishing reliable distribution networks will better capitalize on market growth.

Recent global disruptions have underscored the importance of supply resilience, prompting manufacturers of OPTIRAY 240 to diversify sourcing strategies and adopt advanced manufacturing technologies like continuous processing.

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Market Challenges and Risks

• Regulatory Challenges: Evolving safety standards, especially regarding iodine-related adverse effects, could impose additional compliance costs.
• Market Competition: Price erosion driven by generics and biosimilars can depress revenue.
• Safety Concerns: Incidents of contrast-induced nephropathy (CIN) influence clinical preferences and regulatory scrutiny.
• Adoption Barriers: Institutional inertia and cost considerations may slow incorporation into new healthcare settings.

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Future Outlook and Investment Opportunities

Investors should watch for the development of next-generation contrast agents with improved safety profiles and diagnostic capabilities. Strategic acquisitions or partnerships with imaging technology firms could enhance OPTIRAY 240’s clinical utility and market scope.

Research into personalized imaging protocols may further refine patient selection and dosage optimization, reducing costs and adverse events, ultimately elevating the drug’s market share.

Given the positive macro trend toward increased diagnostic imaging, pharmaceutical companies manufacturing OPTIRAY 240 are poised for steady revenue growth, contingent upon navigating regulatory environments and competitive pressures.

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Key Takeaways

• The global demand for high-quality contrast media like OPTIRAY 240 is driven by rising chronic disease prevalence and increased imaging procedures.
• Regulatory approvals in major markets have facilitated its market penetration, with reimbursement policies serving as critical enablers.
• Competition from established and generic contrast agents presents both challenges and opportunities; differentiation through safety and performance is key.
• The expanding global contrast media market supports optimistic revenue projections, with potential to surpass USD 300 million in annual sales within five years.
• Supply chain robustness and ongoing safety assurance will be central to maximizing the financial trajectory of OPTIRAY 240.

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FAQs

1. What are the primary clinical advantages of OPTIRAY 240 over competitors?
OPTIRAY 240 offers high iodine concentration, enabling superior contrast resolution in CT imaging, which facilitates more precise diagnoses. Its favorable safety profile, including lower osmolality, reduces the risk of adverse events like contrast-induced nephropathy.

2. How does regulatory approval impact the market potential of OPTIRAY 240?
Regulatory approval in key jurisdictions ensures market access and reimbursement eligibility. It validates safety and efficacy, fostering clinician confidence and accelerating adoption.

3. What factors could limit the growth of OPTIRAY 240?
Price competition from generics, safety concerns related to iodine use, evolving regulatory standards, and institutional inertia could temper growth prospects.

4. Are there emerging innovations that could disrupt the contrast media market?
Yes. Nanoparticle-based contrast agents and novel imaging techniques such as dual-energy CT may challenge traditional contrast agents, influencing future demand.

5. What strategic moves should manufacturers consider?
Investing in clinical research to demonstrate superior safety, expanding into emerging markets, and forming strategic alliances with imaging technology companies can enhance competitive positioning.

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Sources

[1] FDA Approvals and Regulatory Information. U.S. Food and Drug Administration, 2019.
[2] Global Burden of Disease Study 2022. World Health Organization.
[3] International Society of Radiology. Annual Imaging Procedures Report, 2022.
[4] MarketsandMarkets. Contrast Media Market Forecast, 2022–2028.

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Disclaimer: This analysis is for informational purposes only and does not constitute investment advice.