OPTIRAY 160 Drug Patent Profile

When do Optiray 160 patents expire, and what generic alternatives are available?

Optiray 160 is a drug marketed by Liebel-flarsheim and is included in one NDA.

The generic ingredient in OPTIRAY 160 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 160

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	3
Patent Applications:	2,687
DailyMed Link:	OPTIRAY 160 at DailyMed

Recent Clinical Trials for OPTIRAY 160

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 160 clinical trials

Pharmacology for OPTIRAY 160

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

US Patents and Regulatory Information for OPTIRAY 160

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 160	ioversol	INJECTABLE;INJECTION	019710-003	Dec 30, 1988		DISCN	No	No

Expired US Patents for OPTIRAY 160

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 160	ioversol	INJECTABLE;INJECTION	019710-003	Dec 30, 1988	4,396,598

International Patents for OPTIRAY 160

See the table below for patents covering OPTIRAY 160 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 160

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 OPTIRAY 160

Last updated: July 29, 2025

Introduction

OPTIRAY 160, known generically as iodixanol, is a nonionic, iso-osmolar contrast agent widely used in diagnostic radiology, specifically in computed tomography (CT) scans. Approved for intravascular use, OPTIRAY 160 enhances imaging clarity, crucial for accurate diagnosis. Over recent years, its market dynamics have been shaped by technological advancements, regulatory developments, competitive landscape, and evolving healthcare needs. This analysis delineates the product’s market trajectory, exploring drivers, challenges, and financial prospects poised to influence its future positioning within the global contrast media market.

Market Overview

The global contrast agents market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6%, reaching an estimated valuation of USD 5 billion by 2028. Factors fueling this growth include increasing prevalence of chronic diseases amenable to imaging, expanding imaging procedures, and technological innovations in contrast media formulations. OPTIRAY 160, as an iodinated contrast agent, stands to benefit from these trends, especially given its favorable safety profile compared to ionic and high-osmolar agents.

Market Drivers

Increasing Imaging Procedures

The global increase in diagnostic imaging, particularly CT scans, propels demand for contrast agents like OPTIRAY 160. The COVID-19 pandemic accelerated the adoption of advanced imaging modalities to diagnose and monitor respiratory and cardiovascular complications, further amplifying demand [1].

Safety and Efficacy Profile

OPTIRAY 160's iso-osmolar properties confer a safety advantage, reducing adverse reactions like nephrotoxicity and allergic responses associated with high-osmolar agents. Growing awareness among clinicians about safety profiles influences prescribing patterns toward iso-osmolar contrast media.

Aging Population and Disease Burden

Rising incidences of cardiovascular disease, cancer, and neurological disorders necessitate frequent imaging, thereby expanding the utilization of contrast media. Elderly populations are particularly susceptible to chronic diseases requiring imaging, which favors products like OPTIRAY 160 with proven safety records.

Regulatory Approvals and Market Penetration

The product’s regulatory approval across multiple jurisdictions, including FDA and EMA, facilitates broad adoption. Moreover, increasing reimbursement coverage for imaging procedures enhances accessibility, positively impacting sales.

Market Challenges

Competitive Landscape

OPTIRAY 160 faces competition from several other contrast agents, including iohexol, iopamidol, and newer low-osmolar and macrocyclic agents. While its safety profile provides differentiation, pricing pressures and patent expirations of competitors influence market dynamics.

Price Sensitivity and Reimbursement Policies

Healthcare payers worldwide impose strict reimbursement policies, pressuring manufacturers to optimize pricing strategies. Cost-effectiveness analyses comparing various contrast agents influence formulary decisions and segment-specific sales.

Supply Chain and Manufacturing Complexities

Maintaining consistent quality and supply, especially amid global disruptions like the COVID-19 pandemic, remains critical. Manufacturing scale-up or disruption can impact availability and financial performance.

Financial Trajectory and Market Potential

Historical Revenue Performance

While specific revenue figures for OPTIRAY 160 are limited publicly, the broader iodinated contrast media segment has exhibited steady growth, driven by increased imaging procedures. Leading manufacturers of contrast agents have reported revenue increases ranging from 5-8% annually.

Forecasted Revenue Growth

Based on current market assumptions, OPTIRAY 160’s sales are expected to grow at a CAGR of approximately 4-6% over the next five years. This projection accounts for increasing global imaging procedures, expanded geographical reach—particularly in emerging markets—and continued recognition of its safety benefits.

Pricing and Market Share Projections

Pricing strategies will be pivotal. As patent protections wane and generics proliferate, unit prices may decline, but overall sales volumes could compensate. Market share will likely stabilize with established clinical preferences, although innovation in contrast formulations may introduce new competitors.

Strategic Opportunities

• Geographical Expansion: Increasing adoption in emerging markets like Asia-Pacific, Latin America, and Middle East-Africa offers significant growth potential.

• Technological Advancements: Integration with new imaging techniques and development of more biocompatible formulations could differentiate OPTIRAY 160.

• Partnerships and Collaborations: Strategic alliances with healthcare providers and policymakers can facilitate broader utilization.

Regulatory and Competitive Landscape

Regulatory agencies enforce stringent standards for contrast agents, focusing on safety and efficacy. OPTIRAY 160’s approval trajectories in key markets like the US, Europe, and Asia influence its financial future. The competitive landscape comprises key players like GE Healthcare (Omnipaque), Bayer (Ultravist), and Bracco (Xenetix), all investing heavily in innovation and marketing.

Patent expirations of competing products impose price competition, benefiting established agents with safety advantages, such as OPTIRAY 160. Nonetheless, ongoing development of newer contrast agents with reduced side effects may challenge its market share.

Impact of Technological and Clinical Innovations

Emerging imaging modalities, like dual-energy CT, require specific contrast formulations, creating both challenges and opportunities. OPTIRAY 160’s versatility could be harnessed to adapt to such technologies, influencing its future financial trajectory.

Conclusion

The market dynamics surrounding OPTIRAY 160 exhibit a balanced interplay of growth drivers and challenges. Its favorable safety profile and expanding global imaging landscape support a steady financial trajectory, with an estimated CAGR of 4-6% over the next five years. Strategic positioning, geographical expansion, and continuous innovation remain critical to maximizing its market potential.

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Key Takeaways

• The global contrast media market is projected to grow primarily driven by increasing diagnostic imaging and an aging population.
• OPTIRAY 160 benefits from a strong safety profile and broad regulatory approvals, supporting steady demand.
• Competition and pricing pressures necessitate strategic marketing and innovation.
• Emerging markets and technological advances offer significant growth avenues.
• Maintaining supply chain stability and leveraging clinical advances will be vital for sustained financial success.

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FAQs

1. What are the main advantages of OPTIRAY 160 over other contrast agents?
   Its iso-osmolar properties reduce common adverse reactions like nephrotoxicity and allergic responses, enhancing patient safety.

2. How has the COVID-19 pandemic affected the demand for OPTIRAY 160?
   The pandemic increased the utilization of diagnostic CT scans, thereby driving demand for contrast agents like OPTIRAY 160 used in imaging of COVID-19-related complications.

3. What are the key factors influencing OPTIRAY 160’s market share?
   Safety profile, regulatory approvals, pricing competitiveness, technological compatibility, and geographical expansion efforts are primary determinants.

4. In which regions is OPTIRAY 160 expected to experience the fastest growth?
   Emerging markets in Asia-Pacific, Latin America, and the Middle East-Africa region are poised for rapid growth due to expanding healthcare infrastructure and imaging needs.

5. What future innovations could impact OPTIRAY 160’s market position?
   Developments in dual-energy CT, custom contrast formulations, and reduced side-effect profiles could influence its clinical adoption and market standing.

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References

[1] MarketWatch. "Contrast Media Market Size, Share & Trends Analysis Report." 2022.