OPTIRAY 350 Drug Patent Profile

When do Optiray 350 patents expire, and what generic alternatives are available?

Optiray 350 is a drug marketed by Liebel-flarsheim and is included in two NDAs.

The generic ingredient in OPTIRAY 350 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 350

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 350 at DailyMed

Recent Clinical Trials for OPTIRAY 350

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 350 clinical trials

Pharmacology for OPTIRAY 350

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

US Patents and Regulatory Information for OPTIRAY 350

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 350	ioversol	INJECTABLE;INJECTION	019710-005	Jan 22, 1992		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	020923-003	May 28, 1998		RX	Yes	Yes

Expired US Patents for OPTIRAY 350

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	019710-005	Jan 22, 1992	4,396,598
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	020923-003	May 28, 1998	4,396,598

International Patents for OPTIRAY 350

See the table below for patents covering OPTIRAY 350 around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S58131970	COMPOUND
Australia	552188
Japan	H0224252
Canada	1198739	DERIVES DE 2,4,6-TRIIODOISOPHTALAMIDE (2,4,6-TRIIODOISOPHTHALAMIDE DERIVATIVE)

Supplementary Protection Certificates for OPTIRAY 350

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OPTIRAY 350

Last updated: August 4, 2025

Introduction

OPTIRAY 350 (iodinated contrast agent, ioversol) is a radiological contrast medium utilized primarily in diagnostic imaging procedures such as computed tomography (CT) scans. Its pivotal role in enhancing imaging clarity has fostered substantial utilization within hospital settings worldwide. This analysis explores the current market dynamics and predicts future financial trajectories, emphasizing clinical demand drivers, competitive landscape, regulatory influences, and pricing strategies that collectively shape OPTIRAY 350’s commercial prospects.

Market Overview and Segmentation

The global contrast media market, estimated at USD 4.2 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of approximately 4.1% through 2030 [1]. Within this domain, iodinated contrast agents—including OPTIRAY 350—constitute roughly 65% of the market, owing to their extensive application across diagnostic imaging.

Segmented by application, the market for iodinated contrast media is primarily distributed across:

• Computed Tomography (CT): Approx. 70% market share
• X-ray Angiography: 15%
• Other Imaging Modalities: 15%, including fluoroscopy

The rising prevalence of chronic diseases necessitating advanced imaging, coupled with technological advancements in CT imaging, underpins ongoing demand growth for contrast agents like OPTIRAY 350.

Key Drivers of Market Dynamics

Increasing Diagnostic Imaging Procedures

The continuous rise in diagnostic imaging procedures globally propels demand for contrast media. The global increase in the aging population, coupled with the escalating burden of cardiovascular and oncological diseases, further amplifies this trend [2].

Technological Advancements

Improvements in CT imaging resolution and reduced scan times have expanded the scope of contrast agents, promoting safer and more efficient diagnostics. OPTIRAY 350 benefits from features such as rapid injection and optimal iodine concentration, ensuring procedural efficacy.

Growing Healthcare Infrastructure

Emerging markets are witnessing expanding healthcare infrastructure, which increases access to advanced imaging technologies and contrast media. Asia-Pacific is notably poised for substantial growth, driven by investments in healthcare facilities and rising medical tourism.

Regulatory and Safety Considerations

Regulatory agencies like the FDA and EMA enforce strict safety guidelines for contrast media use. The safety profile of OPTIRAY 350, characterized by low incidence of adverse reactions, aligns with these mandates, fostering clinician confidence and continued utilization.

Competitive Landscape

The iodinated contrast media market is marked by intense competition among major players, including GE Healthcare, Bracco Imaging, Bayer, and Guerbet. These companies differentiate through product efficacy, safety profiles, and pricing strategies.

OPTIRAY 350 competes on factors such as:

• Safety and Tolerability: Demonstrates a low risk profile, including minimal nephrotoxicity, vital in populations with renal impairment.
• Product Differentiation: Its unique formulation offers high-quality visualization, especially in challenging imaging conditions.
• Brand Loyalty and Distribution: Integration within hospital procurement networks influences market penetration.

The presence of newer, low-osmolar, and iso-osmolar contrast agents exerts pressure on OPTIRAY 350’s market share, emphasizing the importance of pharmacovigilance and targeted marketing.

Regulatory and Reimbursement Environment

Regulatory bodies continuously review contrast agents for safety and efficacy, influencing market access. Reimbursement policies significantly impact product adoption rates; favorable reimbursement fosters broader use, especially in outpatient settings.

In regions with limited reimbursement—particularly certain emerging markets—cost considerations may curb demand growth, unless OPTIRAY 350 is positioned competitively in pricing.

Pricing Dynamics and Revenue Projections

The average price per dose of iodinated contrast agents varies by region, with Western markets favoring premium pricing due to established safety profiles. Price erosion due to generic competition and the introduction of alternative imaging modalities (e.g., MRI) restrains revenue growth.

Revenue estimates:
Based on current utilization rates and pricing, global sales of OPTIRAY 350 could approximate USD 250–300 million annually over the next five years, assuming stable hospital adoption and no significant safety concerns.

Potential Market Challenges

• Emergence of Alternative Modalities: MRI and ultrasound imaging reduce reliance on iodinated contrast agents, particularly in certain diagnostic contexts.
• Safety Concerns and Regulations: Rare but serious adverse events like contrast-induced nephropathy may impact prescribing behaviors.
• Pricing Pressures: Cost-sensitive markets may see reduced margins due to commoditization and competitive pricing.

Financial Trajectory Outlook

Short-term (1–3 years):

Stable demand driven by increasing imaging procedures; marginal growth influenced by broader healthcare expenditure and infrastructure expansion.

Mid-term (4–7 years):

Potential plateau in mature markets; growth may be sustained in emerging regions with expanding healthcare access.

Long-term (8+ years):

Market penetration could diminish due to technological shifts and rising competition, necessitating differentiation strategies, such as developing next-generation contrast agents or expanding into niche indications.

Strategic Implications

• Emphasize ongoing safety profile improvements and tailored formulations for specific patient populations.
• Strengthen regulatory positioning to facilitate seamless market access.
• Explore strategic partnerships for distribution in emerging markets.
• Invest in marketing that underscores clinical efficacy and safety, fostering clinician loyalty.

Key Takeaways

• Market growth hinges on rising imaging demand and technological advancements but faces competitive pressures from alternative modalities.
• Regulatory and reimbursement environments are pivotal; favorable policies underpin sustained sales.
• Pricing strategies must navigate cost and safety considerations to maintain competitiveness, especially amidst patent expirations and generic entries.
• Emerging markets present growth opportunities, provided companies adapt to local healthcare infrastructure and economic conditions.
• Innovation in contrast media formulations and expansion into niche applications are vital for long-term financial success.

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FAQs

1. What factors influence the market share of OPTIRAY 350 amid competitors?
Product efficacy, safety profile, clinician preference, regulatory approvals, pricing, and distribution reach significantly impact market share. Differentiation through safety and performance remains key.

2. How might technological advancements impact OPTIRAY 350’s demand?
Advances favoring MRI and ultrasound imaging could reduce reliance on iodinated contrast agents, potentially constraining long-term demand unless combined with innovative solutions or expanded indications.

3. What role does regulation play in shaping OPTIRAY 350’s market trajectory?
Regulatory agencies’ safety and efficacy standards directly influence market access, approval timelines, and usage guidelines, thereby affecting sales volume and growth potential.

4. How can the company optimize revenue amidst pricing pressures?
Strategies include emphasizing product safety and efficacy, diversifying product portfolio, expanding into emerging markets, and engaging in value-based pricing models aligned with clinical outcomes.

5. What are the key risks facing OPTIRAY 350’s market expansion?
Risks include emerging competition, regulatory setbacks, safety concerns, reimbursement limitations, and shifts towards alternative imaging modalities.

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Sources

[1] Markets and Markets. Contrast Media Market by Type, Application, End User - Global Forecast to 2030.

[2] World Health Organization. Global Health Data on Imaging Modalities and Disease Burden.