OMNIPAQUE 12 Drug Patent Profile

When do Omnipaque 12 patents expire, and what generic alternatives are available?

Omnipaque 12 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 12 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 12

A generic version of OMNIPAQUE 12 was approved as iohexol by AMNEAL on November 13^th, 2025.

Summary for OMNIPAQUE 12

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for OMNIPAQUE 12

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 12	iohexol	SOLUTION;ORAL	018956-009	Apr 17, 2018		RX	Yes	Yes

International Patents for OMNIPAQUE 12

See the table below for patents covering OMNIPAQUE 12 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
Switzerland	544551	Neue Röntgenkontrastmittel
Germany	2031724
Denmark	130709

Investment Scenario and Fundamentals Analysis for OMNIPAQUE 12

Last updated: March 8, 2026

What is OMNIPAQUE 12?

OMNIPAQUE 12 (ioxitalamate meglumine and iohexol) is a contrast agent used for diagnostic imaging, specifically in computed tomography (CT) scans. It is an iodinated contrast medium designed to enhance the visibility of blood vessels, tissues, and organs during imaging procedures.

Market Overview and Demand Drivers

Size and Growth

The global iodinated contrast media market was valued at approximately $4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.8% between 2023 and 2030. The increasing adoption of CT imaging, driven by:

• Rising prevalence of cardiovascular diseases
• Expanding geriatric population
• Technological advancements in imaging

contribute to market expansion.

Key End-Uses

• Diagnostic radiology
• Interventional procedures
• Oncology imaging

Regional Market Distribution

North America holds about 45% of the market, driven by high healthcare expenditure and widespread adoption. Europe accounts for approximately 25%, with increased adoption in emerging markets such as Asia-Pacific, which shows signs of rapid growth.

Competitive Landscape

Major competitors include:

• GE Healthcare (Omnipaque)
• Bracco Group (Xenetic)
• Guerbet (Reserve)

Market leaders such as GE control over 60% of the global contrast media market, with Omnipaque (iohexol) being a flagship product.

Product Specifics: OMNIPAQUE 12

Technical Characteristics

• Concentration: 300 mg I/mL (standard 350 mg I/mL, but 12 indicates a lower concentration formulation)
• Volume: Typically supplied in 50 mL, 100 mL vials
• Pharmacokinetics: Rapid distribution and elimination, mostly renal excretion
• Safety Profile: Well-established, with manageable adverse effects

Regulatory Status

Approved by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulators for CT imaging procedures.

Investment Fundamentals

Revenue and Pricing

OMNIPAQUE is sold via direct sales and distribution channels. Pricing varies regionally, with average list prices around $50-$70 per 50 mL vial. Volume-based discounts apply to hospitals and imaging providers.

Revenue Figures

• 2022 Revenue: Estimated $700 million globally
• Market Share: Approximately 35% of the iodinated contrast media segment

Cost Structure

Manufacturing costs include iodine raw materials, stabilization compounds, and quality controls, averaging approximately 20-25% of sales prices.

Profitability

Gross margins for contrast agents like OMNIPAQUE hover around 70%, reflecting high gross profitability typical in pharmaceuticals with stable demand.

Patents and Intellectual Property

Existing patents for iohexol formulations have lapsed in several regions, opening opportunities for generic entrants. Brand loyalty remains high due to clinical familiarity and regulatory approval.

R&D and Pipeline

No recent reports indicating significant pipeline developments specifically for OMNIPAQUE. Industry trends favor generic proliferation and biosimilar entry.

Investment Risks

• Patent expiration and generic competition erode market share
• Regulatory shifts impacting approvals and labeling
• Safety concerns, if new adverse effects emerge, could dampen demand
• Market saturation in developed regions

Strategic Considerations

• Growing demand in emerging markets offers expansion prospects
• Potential for formulary shifts favoring lower-cost generics
• Technology advances in alternative imaging modalities may reduce reliance on contrast agents

Financial and Market Outlook

Most revenue streams are stable, with mature growth in established markets. Future growth hinges on geographic expansion and clinical adoption in emerging markets.

Key Takeaways

• OMNIPAQUE 12 operates in a mature market with high gross margins.
• The global contrast media segment is projected to grow at nearly 5% CAGR through 2030.
• Patent expirations and generics pose significant competitive risks.
• Expansion opportunities exist in emerging markets, driven by rising healthcare investments.
• Regulatory and safety considerations influence long-term demand trajectories.

FAQs

1. How does OMNIPAQUE 12 compare to other contrast agents?
It has a comparable safety and efficacy profile to competitors like Isovue and Telebrix but benefits from brand recognition and regulatory approval as a trusted CT contrast medium.

2. What are the key factors affecting the pricing of OMNIPAQUE 12?
Pricing depends on regional healthcare policies, volume discounts, competitive generic entries, and formulary placements.

3. Is there potential for new formulations or delivery methods?
Current focus remains on maintaining formulation stability. Laboratories explore lower volumes and concentrations, which could affect traditional dosing practices.

4. How vulnerable is OMNIPAQUE to regulatory changes?
Vulnerabilities include safety concerns, labeling requirements, and approval policies, especially concerning iodine-related adverse events.

5. What are the main growth avenues for investors?
Emerging markets expansion and potential acquisition opportunities focusing on contrast media portfolios present growth avenues.

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References:
[1] MarketsandMarkets. (2023). Contrast media market forecast. Retrieved from https://www.marketsandmarkets.com/
[2] MedTech Innovation Report. (2022). Global contrast agent industry analysis [Report].
[3] U.S. Food and Drug Administration. (2022). OMNIPAQUE approval documents.
[4] European Medicines Agency. (2022). EMA regulatory dossier for iohexol.