OMNIPAQUE 240 Drug Patent Profile

When do Omnipaque 240 patents expire, and when can generic versions of Omnipaque 240 launch?

Omnipaque 240 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in OMNIPAQUE 240 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Omnipaque 240

A generic version of OMNIPAQUE 240 was approved as iohexol by AMNEAL on November 13^th, 2025.

Summary for OMNIPAQUE 240

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	4,182
DailyMed Link:	OMNIPAQUE 240 at DailyMed

Recent Clinical Trials for OMNIPAQUE 240

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

Sponsor	Phase
Breakthrough T1D	PHASE2
University of California, San Diego	PHASE2
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal	Phase 4

See all OMNIPAQUE 240 clinical trials

Pharmacology for OMNIPAQUE 240

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

US Patents and Regulatory Information for OMNIPAQUE 240

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985		RX	Yes	Yes
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	020608-001	Oct 24, 1995		DISCN	No	No

Expired US Patents for OMNIPAQUE 240

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985	4,021,481
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985	4,396,597
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985	4,250,113

International Patents for OMNIPAQUE 240

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

Country	Patent Number	Title	Estimated Expiration
Australia	523295
Germany	2031724
Netherlands	153083
Sweden	7706792
Japan	S6210209

Market Dynamics and Financial Trajectory for OMNIPAQUE 240

Last updated: July 29, 2025

Introduction

OMNIPAQUE 240 (iodixanol) is a contrast agent used primarily in diagnostic imaging procedures, such as computed tomography (CT) scans, to enhance image clarity. As a non-ionic, dimeric contrast medium, OMNIPAQUE's unique pharmacological profile offers advantages over traditional ionic agents, including reduced risk of adverse reactions and enhanced diagnostic efficacy. The drug's market dynamics and financial trajectory are influenced by technological advancements, clinical preferences, regulatory developments, and broader healthcare trends. This analysis explores these factors comprehensively, offering insights relevant to stakeholders, investors, and industry strategists.

Market Overview

Global Demand and Market Size

The global contrast media market was valued at ~$4.4 billion in 2022, with a compounded annual growth rate (CAGR) projected around 4-6% through 2028[1]. OMNIPAQUE, as a prominent iodinated contrast agent, contributes significantly to this market segment. The increasing prevalence of chronic and lifestyle-related diseases like cardiovascular conditions, cancer, and neurological disorders underpins the rising demand for diagnostic imaging, subsequently fueling the growth of contrast agents such as OMNIPAQUE.

Market Share and Competitive Landscape

OMNIPAQUE holds a substantial segment within the iodinated contrast media category, competing with agents like Iohexol (Omnipaque's primary competitor), iopamidol, and iodinated agents from other manufacturers. Its positioning benefits from advantages such as high osmolality, improved imaging quality, and favorable safety profiles. Nevertheless, competition intensifies as newer agents with improved safety and cost-effectiveness emerge, prompting manufacturers to innovate continuously.

Regional Market Dynamics

North America remains the largest market, driven by high healthcare expenditure, widespread adoption of advanced imaging, and robust regulatory environments[2]. Europe follows, with increasing penetration in emerging markets across Asia-Pacific and Latin America, where expanding healthcare infrastructure and rising disease burden propel demand. Notably, regulatory approvals and reimbursement policies critically influence regional uptake.

Key Market Drivers

Technological Innovations

Advances in imaging technology, such as high-resolution CT and hybrid modalities, demand high-quality contrast agents. OMNIPAQUE's dimers' properties facilitate superior image clarity, encouraging continued use in complex diagnostic procedures.

Increasing Disease Prevalence

The escalating incidence of cardiovascular diseases, cancers, and neurological disorders globally enhances the need for reliable diagnostic agents. For instance, the WHO reports that cardiovascular diseases are the leading cause of death worldwide, necessitating frequent imaging and contrast enhancement[3].

Safety Profile and Patient Demand

Patients and clinicians favor contrast agents with lower adverse reactions. OMNIPAQUE's non-ionic structure reduces risks associated with ionic contrast media, leading to broader acceptance, especially in patients with contraindications to other agents.

Regulatory and Reimbursement Factors

Regulatory approvals in key markets bolster confidence in OMNIPAQUE. Favorable reimbursement policies also promote utilization, although cost-containment efforts can challenge pricing strategies.

Market Challenges

Safety and Adverse Reactions

Despite its safety profile, OMNIPAQUE can induce adverse events such as contrast-induced nephropathy (CIN), especially in vulnerable populations. Mounting concerns about nephrotoxicity impact its market penetration among high-risk groups.

Cost Competition

Emerging cost-effective alternatives, including newer contrast agents with lower doses or better safety profiles, threaten market share. Additionally, increasing preferences for non-contrast imaging modalities in certain diagnostics constrain growth.

Regulatory and Environmental Concerns

Regulatory scrutiny over contrast media related to environmental impact—particularly concerning iodinated compounds in wastewater—can impose additional compliance costs.

Financial Trajectory

Revenue Trends

Historically, OMNIPAQUE's revenues have reflected the overall health of the contrast media market, with incremental growth driven by expanding imaging indications and new geographic markets. In the mid-2010s, the drug posted annual revenues exceeding $200 million globally, with steady but incremental increases[4].

Pricing Strategies

Pricing remains a critical factor. Manufacturers aim to balance profitability with market competitiveness. Reimbursement levels significantly influence sales, particularly in regions with strict healthcare budgets.

Research and Development Costs

Investments into R&D are vital for maintaining market relevance. Developing next-generation contrast agents with improved safety and efficacy incurs substantial expenditure, impacting short-term financial metrics but promising long-term growth.

Market Penetration and Expansion

Emerging markets offer significant growth prospects. Strategic partnerships and localized manufacturing facilitate regulatory approvals and cost reduction, bolstering revenue potential.

Impact of Industry Consolidation

Mergers and acquisitions within the contrast media segment influence market dynamics and can affect pricing, innovation, and supply chains, ultimately impacting OMNIPAQUE's financial trajectory.

Regulatory Environment and Market Access

Regulatory approvals from FDA, EMA, and other global health authorities are essential for market access. OMNIPAQUE received FDA approval in 2004[5], and subsequent approvals have maintained its market presence. Strict labeling, safety warnings, and environmental compliance are increasingly influencing marketing strategies.

Future Outlook

Innovative Developments

The horizon includes the integration of digital health technologies and personalized imaging protocols, potentially influencing contrast agent selection. Next-generation agents with reduced osmolality, lower required doses, and enhanced safety profiles are under development, which could challenge or complement OMNIPAQUE's market share.

Market Expansion

Asia-Pacific and Latin America are poised for growth, driven by rising healthcare infrastructure investments and increasing disease burden. Localization of manufacturing and strategic regional collaborations will accelerate adoption.

Digital Transformation and Reimbursement Models

Value-based care models emphasize outcome-driven diagnostics. Pharmacoeconomic evaluations and reimbursement negotiations will influence pricing and utilization patterns for OMNIPAQUE.

Conclusion

The market dynamics surrounding OMNIPAQUE 240 are shaped by technological advances, demographic trends, regulatory frameworks, and competitive pressures. While currently maintaining a significant market position, its financial trajectory hinges on innovation, safety enhancements, strategic expansion, and healthcare policy shifts. Stakeholders must monitor evolving clinical preferences, environmental considerations, and healthcare economics to optimize investment and operational strategies within this segment.

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Key Takeaways

• Demand growth is driven by increasing diagnostic imaging needs, aging populations, and disease prevalence.
• Technological innovation and improved safety profiles bolster OMNIPAQUE's competitiveness, but emerging alternatives pose challenges.
• Regional expansion, especially in Asia-Pacific, offers substantial growth opportunities amid healthcare infrastructure improvements.
• Pricing strategies and reimbursement policies significantly influence revenue trajectories, with cost containment impacting adoption.
• Regulatory considerations and environmental compliance are increasingly critical, demanding proactive risk management strategies.

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FAQs

1. What are the main advantages of OMNIPAQUE 240 over ionic contrast agents?
OMNIPAQUE's non-ionic, dimeric structure reduces adverse reactions like allergic responses and contrast-induced nephropathy, improving safety profiles and patient tolerability.

2. How does regulatory approval impact OMNIPAQUE’s market access?
Regulatory approvals from authorities like the FDA and EMA enable commercialization, influence reimbursement policies, and improve clinician confidence, directly affecting sales and market penetration.

3. What are the key factors affecting the pricing of OMNIPAQUE?
Pricing is influenced by manufacturing costs, competitive landscape, reimbursement environments, clinical efficacy, safety profiles, and regional economic policies.

4. How are emerging technologies influencing the contrast media market?
Advanced imaging modalities and the development of lower-osmolality, targeted contrast agents push manufacturers to innovate, potentially disrupting existing market leaders like OMNIPAQUE.

5. What future opportunities exist for expanding OMNIPAQUE’s market share?
Expansion into emerging markets, ongoing safety improvements, strategic partnerships, and integrating digital health solutions hold potential for increasing OMNIPAQUE’s reach and profitability.

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Sources:

[1] MarketsandMarkets, "Contrast Media Market," 2022.
[2] GlobalData, "Imaging Agents and Contrast Media," 2022.
[3] WHO, "Cardiovascular Diseases Fact Sheet," 2023.
[4] IQVIA, "Contrast Media Sales Data," 2021.
[5] FDA, "OMNIPAQUE Approval Letter," 2004.