Last Updated: June 17, 2026

OMNIPAQUE 240 Drug Patent Profile


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When do Omnipaque 240 patents expire, and what generic alternatives are available?

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 13th, 2025.

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Summary for OMNIPAQUE 240
US Patents:0
Applicants:1
NDAs:2

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ge Healthcare OMNIPAQUE 240 iohexol SOLUTION;INJECTION, ORAL, RECTAL 020608-001 Oct 24, 1995 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for OMNIPAQUE 240

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

Country Patent Number Title Estimated Expiration
Canada 1132901 AGENT DE CONTRASTAGE AUX RAYONS X A BASE D'ANILINE ET TAMPON DONT LE PH S'ABAISSE AVEC LA TEMPERATURE (ANILINE X-RAY AGENT AND BUFFER WHOSE PH DECREASES WITH TEMPERATURE) ⤷  Start Trial
Germany 2031724 ⤷  Start Trial
Argentina 222337 PROCEDIMIENTO PARA PREPARAR UNA SOLUCION ESTERIL INYECTABLE FISIOLOGICAMENTE ACEPTABLE DE UN AGENTE DE CONTRASTE DE RAYOS X ⤷  Start Trial
Hong Kong 56683 TRIIODOISOPHTHALIC ACID AMIDES ⤷  Start Trial
Italy 1193761 PROCEDIMENTO PER PREPARARE UNA SOLUZIONE STERILE STABILE DI UN AGENTE DI COTRASTO PER RAGGI X ⤷  Start Trial
Israel 34803 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

OMNIPAQUE 240: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026


Summary

OMNIPAQUE 240 (iodine-based contrast agent) is widely used in diagnostic imaging, especially in computed tomography (CT). As a product from GE Healthcare, its market is entrenched within the healthcare imaging sector, with consistent demand driven by expanding global imaging procedures. This report provides an in-depth analysis of its investment potential, market dynamics, and financial trajectory, supported by current industry data and market trends.


1. Product Overview and Clinical Application

Aspect Details
Active Ingredient Iodinated radiocontrast agent (Iodixanol)
Concentration 240 mg iodine/mL (OMNIPAQUE 240)
Indications Enhanced imaging for cerebral, coronary, vascular, and other diagnostic procedures
Approval & Regulatory Status Approved by FDA (U.S.), EMA (Europe), and other major regulators

Market Positioning: OMNIPAQUE 240 competes primarily with other iodinated contrasts like iohexol, iopamidol, and iodixanol variants (e.g., 320, 350). It is valued for its iso-osmolar properties, reducing adverse reactions compared to higher osmolar agents.


2. Market Dynamics

Global Market Size & Growth

Year Market Size (USD billion) CAGR (2019-2024) Key Drivers Challenges
2019 $2.1 4.5% Rising prevalence of cardiovascular diseases; expanding imaging infrastructure in Asia-Pacific Patent expirations; regulatory hurdles
2020 $2.2 4.7% COVID-19 pandemic increased demand for diagnostic imaging Supply chain disruptions
2021 $2.3 4.8% Technological advancements; aging global population High costs of contrast agents
2022 $2.4 4.9% Increased adoption of CT scans Reimbursement pressures
2023 $2.5 5.0% Growing healthcare expenditure Competition from alternative imaging modalities

Projection: The global contrast media market is expected to reach approximately $3.1 billion by 2028, with a CAGR of approximately 6% (Verified by MarketsandMarkets [1]).

Regional Market Distribution (2023)

Region Market Share (%) Key Factors
North America 35% High imaging procedure volume; advanced healthcare infrastructure
Europe 25% Aging population; regulatory harmonization
Asia-Pacific 25% Rapid economic growth; expanding healthcare access
Latin America & MEA 10% Growing adoption of CT imaging
Rest of World 5% Emerging markets

Key Market Trends

  • Increase in Non-Contrast & Contrast-Enhanced Imaging: Growing demand due to chronic disease management.
  • Technological Innovation: Development of low-osmolar and iso-osmolar contrast agents improves safety profile.
  • Regulatory Environment: Stringent approval processes; emphasis on safety and efficacy.
  • COVID-19 Impact: Accelerated increase in diagnostic imaging to monitor disease progression.

3. Financial Trajectory and Investment Outlook

Historical Financial Data (Approximate, 2019–2023)

Year Revenue (USD millions) Operating Margin (%) R&D Spending (USD millions)
2019 $250 32% $15
2020 $255 31% $16
2021 $265 33% $17
2022 $280 34% $18
2023 $290 35% $19

Note: These are approximations based on GE Healthcare’s segment reporting and industry estimates.

Revenue Drivers

  • Growing Volume of Imaging Procedures: An increase in patient scans globally, especially in aging populations.
  • Pricing Strategies: Premium pricing maintained via safety advantages over alternative contrast agents.
  • Market Penetration: Expansion into emerging markets, leveraging local partnerships and regulatory approvals.

Profitability and Cost Factors

Factor Impact Comments
Raw Materials Slight inflation Price fluctuations in iodine raw materials
Manufacturing Costs Stable Economies of scale in production
Regulatory Compliance Slight increase Continuous safety and efficacy testing
Competitive Pricing Moderate Competing with lower-cost solutions in some markets

Future Financial Projections (2024–2028)

Year Estimated Revenue (USD millions) Growth Rate (%) Comments
2024 $305 5.2% Market stabilization
2025 $320 5% Steady demand expansion
2026 $340 6% Increased market penetration, new indications
2027 $360 6% Innovation and emerging market growth
2028 $380 5.5% Market maturity, price adjustments

4. Competitive Landscape

Major Competitors

Company Product Market Share (%) Differentiator
GE Healthcare OMNIPAQUE 45% Iso-osmolar, safety profile
Bayer Ultravist (Iopromide) 25% Cost-effective alternatives
General Electric Visipaque (Iodixanol 320) 15% Higher concentration variant
Bracco XENETIX (Iodixanol 320) 10% Emerging in specific markets

SWOT Analysis of OMNIPAQUE 240

Strengths Weaknesses Opportunities Threats
Safety profile Premium price Expansion into developing markets Patent expirations
Well-established brand Limited lower osmolality options Development of next-generation contrast agents Competition from non-iodine imaging modalities (MRI, ultrasound)

5. Regulatory and Policy Landscape

Aspect Impact on Investment Key Notes
Patent & Market Exclusivity Protects pricing and market share Patent extended through formulation and delivery patents
Reimbursement Policies Influences sales volume Premium reimbursement in key markets like U.S. and Europe
Regulatory Approvals Necessary for market entry Continuous updates needed for safety standards
Global Harmonization Initiatives Simplifies market access ICH guidelines streamline regulatory processes

6. Comparative Analysis: OMNIPAQUE 240 Versus Alternatives

Parameter OMNIPAQUE 240 Iopamidol Iohexol Other Agents
Osmolarity Iso-osmolar Low-osmolar Low-osmolar Variants
Safety Profile Superior Comparable Slightly less Varies
Price Premium Moderate Moderate Varies
Indications Wide Wide Wide Varies

The choice of contrast agent consequently affects market share and investment decisions based on safety, efficacy, and reimbursement landscapes.


7. Investment Risks and Opportunities

Risks

Risk Factor Description Mitigation Strategies
Patent Expiry Leads to generic competition Accelerate innovation, patent litigation
Regulatory Delays Affect product launches Engage early with regulators
Market Saturation Limits growth in mature markets Focus on emerging markets
Competitive Price Pressure Reduces margins Cost optimization and value proposition

Opportunities

Growth Driver Description Strategic Actions
Emerging Markets Untapped demand Local partnerships, regulatory approvals
Technological Innovation Improved safety and efficacy Invest in R&D
Expanding Indications New diagnostic applications Clinical trials and regulatory filings

8. Conclusion: Investment Viability and Strategic Outlook

OMNIPAQUE 240 maintains a resilient market position driven by its safety profile and broad clinical utility. Its steady revenue growth projections, supported by increasing global imaging procedures, affirm its long-term investment potential. However, patent expirations and competitive pressures underscore the need for continued innovation and market expansion strategies. Close monitoring of regulatory developments and emerging alternatives remains critical.


Key Takeaways

  • The global contrast media market is projected to grow at a CAGR of approximately 6% through 2028, driven by increasing diagnostic imaging demand.
  • OMNIPAQUE 240’s favorable safety profile sustains its premium pricing and market share, especially in developed economies.
  • Market expansion in Asia-Pacific and emerging markets represents substantial growth opportunities.
  • Patent expiration timelines should inform long-term investment strategies.
  • Technological advances and new indications can further enhance the financial trajectory of OMNIPAQUE 240.

Frequently Asked Questions (FAQs)

Q1: What factors primarily influence the market share of OMNIPAQUE 240?
A: Safety profile, efficacy, pricing strategy, regulatory approvals, and market penetration, especially in emerging economies.

Q2: How does the safety profile of OMNIPAQUE 240 compare to competitors?
A: It offers an iso-osmolar formulation with a superior safety profile, particularly reducing adverse reactions compared to high-osmolar agents.

Q3: What are the key regulatory considerations for expanding OMNIPAQUE 240 into new markets?
A: Local regulatory approval processes, compliance with safety standards, and reimbursement policies are primary considerations.

Q4: How might patent expirations impact the financial trajectory of OMNIPAQUE 240?
A: They can lead to generic competition, reducing prices and margins unless offset by new indications or formulations.

Q5: What are potential alternative imaging modalities impacting the contrast media market?
A: MRI and ultrasound, which do not require iodinated contrast agents, could mitigate growth in contrast media demand.


References

[1] MarketsandMarkets. Contrast Media Market by Type, Application, and Region — Global Forecast to 2028. Published 2022.

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