OPTIRAY 300 Drug Patent Profile

When do Optiray 300 patents expire, and what generic alternatives are available?

Optiray 300 is a drug marketed by Liebel-flarsheim and is included in two NDAs.

The generic ingredient in OPTIRAY 300 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 300

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 300 at DailyMed

Recent Clinical Trials for OPTIRAY 300

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

Sponsor	Phase
Guerbet/Liebel-Flarsheim	Phase 4
Duke Clinical Research Institute	Phase 4
GE Healthcare	Phase 4

See all OPTIRAY 300 clinical trials

Pharmacology for OPTIRAY 300

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

US Patents and Regulatory Information for OPTIRAY 300

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 300	ioversol	INJECTABLE;INJECTION	019710-004	Jan 22, 1992		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	020923-004	May 13, 1999		DISCN	Yes	No

Expired US Patents for OPTIRAY 300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	019710-004	Jan 22, 1992

International Patents for OPTIRAY 300

See the table below for patents covering OPTIRAY 300 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)
European Patent Office	0083964	COMPOUNDS SUITABLE FOR X-RAY VISUALISATION METHODS
Netherlands	930067
Australia	9151182

Supplementary Protection Certificates for OPTIRAY 300

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 300

Last updated: July 31, 2025

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Introduction

OPTIRAY 300, a radiopaque contrast agent, signifies a vital component in medical imaging, particularly computed tomography (CT) scans. Its unique formulation enhances radiographic imaging clarity, facilitating precise diagnostic procedures. Given the critical role of contrast agents in diagnostic medicine, analyzing OPTIRAY 300's market dynamics and financial prospects offers insights into its strategic positioning and potential growth trajectories amid evolving healthcare landscapes.

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Product Profile and Clinical Utility

OPTIRAY 300 comprises an iodine-based contrast medium designed to improve visualization of vascular and tissue structures in CT imaging. Its high iodine concentration (300 mg/mL) ensures optimal image enhancement and rapid administration response, contributing to accurate diagnoses across neurological, cardiovascular, and oncologic applications.

Clinically, OPTIRAY 300 addresses the need for superior image quality with minimal adverse reactions, boosting physician confidence in diagnostic decisions. With an increasing global emphasis on early disease detection, demand for reliable contrast agents like OPTIRAY 300 is expected to sustain growth.

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Market Outlook and Demand Drivers

The global demand for radiocontrast agents is experiencing a steady upward trajectory, driven by several factors:

• Expanding Imaging Procedures: The proliferation of advanced imaging modalities, including multiphase CT and angiography, underpins a rising need for contrast agents. According to a report by MarketsandMarkets, the global medical imaging market is projected to reach USD 50.4 billion by 2026, growing at a CAGR of 6.4% [1].

• Aging Population: Demographic shifts towards aging populations, notably in North America and Europe, elevate the prevalence of cardiovascular diseases and cancers, which frequently necessitate contrast-enhanced imaging.

• Technological Innovation: Innovations in low-osmolar and iso-osmolar contrast media improve patient safety and expand usage, encouraging healthcare providers to adopt newer agents like OPTIRAY 300.

• Rising Healthcare Expenditure: Increased healthcare investment worldwide fosters broader access to advanced diagnostic tools, thereby amplifying contrast agent usage.

Regional Variations: North America leads the market, attributed to high diagnostic imaging adoption and favorable healthcare infrastructure, followed by Europe and Asia Pacific, where rapid economic growth and healthcare reforms augment market potential.

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Competitive Landscape

OPTIRAY 300 enters a competitive arena with several established players:

• Gadolinium-based agents: Predominant in MRI, complementing iodine-based contrast media like OPTIRAY 300 in CT.

• Other Iodinated Contrast Agents: Products such as iohexol, iopamidol, and iodixanol dominate, characterized by similar iodine concentrations and osmolarity profiles.

Major companies manufacturing contrast agents include Guerbet, GE Healthcare, Bracco, and Bayer. These players leverage extensive distribution channels, validated safety profiles, and extensive R&D pipelines to maintain market share.

USP Positioning: OPTIRAY 300's high iodine concentration and safety profile position it as a preferred choice among practitioners seeking high-quality imaging with minimized adverse events.

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Regulatory and Reimbursement Landscape

Regulatory approval by agencies like the FDA and EMA is crucial. OPTIRAY 300’s approval status directly impacts its commercial viability. The drug’s safety record, proven efficacy, and manufacturing standards influence regulatory and reimbursement decisions.

Reimbursement policies significantly affect market uptake. Countries with favorable reimbursement environments for diagnostic procedures see accelerated adoption, bolstering sales potential.

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Market Entry Challenges and Opportunities

Challenges:

• Intense Competition: Entrenched competitors with broad portfolios pose barriers to market penetration.
• Safety Concerns: Rare adverse reactions, including nephrogenic systemic fibrosis, require ongoing safety evaluations.
• Price Sensitivity: Healthcare providers often prioritize cost-effective alternatives, influencing purchasing decisions.

Opportunities:

• Innovative Formulations: Developing osmolality-optimized formulations can mitigate adverse reactions.
• Expanding Indications: Application to emerging diagnostic techniques or therapeutic procedures enhances market relevance.
• Strategic Collaborations: Partnerships with healthcare providers, distributors, and contract research organizations can accelerate market presence.

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Financial Trajectory and Revenue Projections

Forecasting OPTIRAY 300’s financial trajectory involves analyzing market entry timing, pricing strategies, volume sales, and competitive positioning:

• Initial Market Penetration: Entry in secondary markets with high disease burden, such as Asia-Pacific, offers lower barriers with higher growth potential.
• Pricing Strategy: Premium pricing with value-added benefits (e.g., reduced adverse events) could yield higher margins.
• Sales Volume Growth: Tied to regional healthcare infrastructure expansion and adoption rates.

Assuming strategic deployments aligned with global imaging growth projections, revenues could scale significantly within 3-5 years. For example, capturing 2-5% of the iodine-based contrast agent market, valued at approximately USD 3 billion in 2022 [2], could position OPTIRAY 300 as a multi-hundred-million-dollar product within this horizon.

Financial Risks: Market saturation, regulatory delays, and pricing pressures could temper growth. Therefore, diversifying indications and ensuring safety efficacy are critical for sustained revenue escalation.

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Strategic Recommendations

• Invest in R&D: Enhance safety profiles and explore novel formulations to differentiate OPTIRAY 300.
• Expand Geographic Reach: Prioritize emerging markets with expanding healthcare infrastructure.
• Strengthen Regulatory Approvals: Achieve approvals in key markets to expedite sales and reinforce credibility.
• Optimize Pricing and Reimbursement Strategies: Collaborate with payers to ensure reimbursement coverage and competitive pricing.
• Leverage Data and Digital Health: Utilize real-world evidence to demonstrate clinical utility and cost-effectiveness.

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Key Takeaways

• The global contrast agent market is expanding, driven by technological advances and demographic shifts, positioning OPTIRAY 300 for growth.
• Competitiveness hinges on safety profile, formulation innovation, and strategic regulatory approvals.
• Market entry in emerging regions offers substantial near-term opportunities, with long-term growth contingent on establishing clinical and economic value.
• Revenue potential is significant but subject to competitive, regulatory, and pricing challenges.
• Continuous innovation, strategic collaborations, and regulatory diligence are pivotal for maximizing OPTIRAY 300’s financial trajectory.

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Frequently Asked Questions

Q1: How does OPTIRAY 300 compare to other iodine-based contrast agents in terms of safety?
A: OPTIRAY 300’s formulation emphasizes high iodine concentration with a low osmolality profile, reducing hypersensitivity and nephrotoxicity risks, aligning with current safety standards for contrast media.

Q2: What are the primary regulatory hurdles for OPTIRAY 300’s market expansion?
A: Regulatory challenges include demonstrating safety and efficacy across different populations, navigating diverse approval processes, and ensuring manufacturing compliance with international standards.

Q3: How does the aging population influence the demand for OPTIRAY 300?
A: Older populations present higher incidences of cardiovascular and oncological conditions necessitating imaging studies, thus driving increased demand for contrast agents like OPTIRAY 300.

Q4: What pricing strategies could optimize OPTIRAY 300’s market share?
A: Competitive pricing, value-based reimbursement negotiations, and bundling with imaging services can enhance market penetration while ensuring sustainable margins.

Q5: What is the outlook for new technological innovations related to OPTIRAY 300?
A: Innovations such as targeted contrast agents, dual-modality imaging injections, and reduced-osmolar formulations could expand OPTIRAY 300's applications and improve safety, sustaining its market relevance.

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References

[1] MarketsandMarkets. (2022). Medical Imaging Market by Modality, Application, End User — Global Forecast to 2026.
[2] Grand View Research. (2022). Contrast Media Market Size, Share & Trends Analysis Report.