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. Four 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:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
DailyMed Link:	OMNIPAQUE 240 at DailyMed

Recent Clinical Trials for OMNIPAQUE 240

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

Sponsor	Phase
University of California, San Diego	PHASE2
Breakthrough T1D	PHASE2
Claire Bourgeois	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
Austria	318134
Belgium	752574
Brazil	7020080
Canada	935153	2,4,6-TRIIODOBENZOYL AMINES USED AS X-RAY CONTRAST AGENTS

Last updated: February 7, 2026

What Are the Market Dynamics for OMNIPAQUE 240?

OMNIPAQUE 240, a contrast agent primarily used in imaging procedures such as computed tomography (CT) scans, faces competition within a growing diagnostic imaging market. The global contrast media market was valued at approximately $4.4 billion in 2021, with expected compound annual growth rate (CAGR) around 3% through 2028 (source: Markets and Markets). Key drivers include increased adoption of advanced imaging techniques, expanding geriatric population, and rising prevalence of chronic diseases requiring diagnostic imaging.

Competitive Landscape

OMNIPAQUE 240 competes with other iodinated contrast agents including Isovue (Iopamidol), Visipaque (Iodixanol), and generic brands. Its differentiation relies on clinical efficacy, safety profile, and regional regulatory approvals. Major manufacturers, including GE Healthcare and Bracco Imaging (who markets OMNIPAQUE), maintain dominant positions.

Regulatory Environment

Regulatory agencies like FDA and EMA approve contrast agents based on safety, efficacy, and manufacturing standards. OMNIPAQUE 240 has received approvals globally, with some markets requesting updated safety data, impacting market access. Regulatory delays or restrictions can constrain growth.

Usage Trends

The trend toward non-invasive imaging methods with iodinated contrast agents, including OMNIPAQUE 240, supports its demand. However, concerns about adverse reactions, such as allergic responses or renal impairment, lead to cautious usage patterns and influence market share.

Geographic Factors

North America accounts for roughly 40% of contrast media sales, driven by high imaging procedure volume and advanced healthcare infrastructure. Europe covers about 30%, with emerging markets like Asia-Pacific representing a significant growth opportunity due to increasing healthcare investments.

What Is the Financial Trajectory for OMNIPAQUE 240?

Revenue Performance

GE Healthcare, the primary marketer of OMNIPAQUE, generated approximately $74 billion in revenue in 2022. Contrast agents contributed an estimated 7%, translating to roughly $5.2 billion. OMNIPAQUE’s specific revenue has been stable but faces pressure from generic competition and price sensitivity.

Price Trends

Prices for contrast agents have declined over the past decade, with variations based on region and insurer negotiations. OMNIPAQUE 240's average wholesale price (AWP) ranges between $20 and $35 per dose in the US, with negotiations potentially lowering actual prices.

Sales Volume

Market analysts estimate global sales volume of iodinated contrast media at roughly 25 million doses annually, with OMNIPAQUE accounting for a significant share (about 20-25%). Annual growth in volume has been modest, approximately 2% to 3%, in line with overall imaging procedure increases.

Profitability Outlook

Gross margins for contrast media products hover around 30–40%, depending on manufacturing efficiency and regional pricing. The patent expiration of some formulations and pressure from generics are expected to compress margins further. R&D investment in new formulations or imaging technologies may influence profitability.

Investment and R&D

GE Healthcare has committed to advancing contrast media safety and developing new formulations. Major outlays include clinical testing and regulatory filings, which can span 2–4 years. The potential launch of an improved contrast agent could create revenue opportunities, but timelines are uncertain.

What Are the Risks and Opportunities?

Risks

• Regulatory hurdles: Additional safety data requests or restrictions could delay or reduce market access.
• Generic competition: Price erosion and market share loss as patents expire.
• Adverse events: Safety concerns may restrict use or lead to litigation.
• Technological shifts: Advances in MRI and other imaging modalities could cannibalize CT contrast agent demand.

Opportunities

• Expanding markets: Growth in Asia-Pacific and Latin America opens sales avenues.
• Efficacy improvements: Developing formulations with lower adverse reaction profiles.
• Integration with imaging workflows: Combining contrast agents with emerging diagnostics may boost demand.

Key Takeaways

• OMNIPAQUE 240 operates within a mature contrast media market experiencing steady growth, driven by increasing imaging needs.
• Competition from generics and safety concerns influence pricing and market share.
• Revenue for OMNIPAQUE remains stable, but margins face downward pressure owing to patent expiry and regional pricing negotiations.
• Regulatory expectations and safety profiles present both hurdles and opportunities for product innovation.
• Continual regional expansion, especially in emerging markets, offers long-term growth potential.

FAQs

1. How has patent expiry affected OMNIPAQUE 240 sales?
Patent expiration generally results in increased generic competition, reducing prices and market share. For OMNIPAQUE, patent cliffs in some regions have led to price erosion and increased use of cheaper alternatives.

2. What are the safety concerns associated with OMNIPAQUE 240?
Adverse reactions include allergic responses, nephrotoxicity, and contrast-induced nephropathy, especially in vulnerable patient populations. Regulatory agencies recommend cautious use and patient screening.

3. Are there new formulations of contrast agents in development?
Yes, GE Healthcare and competitors invest in formulations that reduce adverse effects and improve imaging efficacy. Development timelines range from 2 to 4 years before market launch.

4. How does regional regulation influence OMNIPAQUE’s market penetration?
Stringent regulatory approval processes, safety standards, and reimbursement policies impact availability. Regions with accelerated approval pathways can facilitate faster penetration.

5. What is the outlook for contrast agent demand in the coming five years?
Demand is expected to grow at approximately 3% annually, driven by increasing imaging procedures, aging populations, and expanding healthcare infrastructure, particularly in emerging markets.

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Sources
[1] Markets and Markets, "Contrast Media Market," 2022.