AMIPAQUE Drug Patent Profile

Which patents cover Amipaque, and what generic alternatives are available?

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

The generic ingredient in AMIPAQUE is metrizamide. There is one drug master file entry for this compound. Additional details are available on the metrizamide profile page.

Summary for AMIPAQUE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for AMIPAQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-003	Sep 12, 1983		DISCN	No	No
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-004	Sep 12, 1983		DISCN	No	No
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-002	Approved Prior to Jan 1, 1982		DISCN	No	No

International Patents for AMIPAQUE

See the table below for patents covering AMIPAQUE around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	34927	NON-IONIC IODINATED X-RAY CONTRAST AGENTS
Japan	S5147702
Finland	53066
France	2053037
Canada	935153	2,4,6-TRIIODOBENZOYL AMINES USED AS X-RAY CONTRAST AGENTS

AMIPAQUE Market Analysis and Financial Projection

Last updated: February 10, 2026

What Is AMIPAQUE and Its Market Position?

AMIPAQUE is the brand name for an iodinated contrast agent primarily used in X-ray imaging procedures. Its active component, iohexol, is administered intravenously to enhance visibility of blood vessels, organs, and tissues during diagnostic imaging. It is a widely used contrast medium in medical imaging, with approvals spanning multiple jurisdictions, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The global market for contrast agents, including iohexol, is projected to grow steadily, driven by increasing demand for advanced imaging diagnostics and rising incidence of cardiovascular and oncological conditions. In 2022, the total contrast media market was valued at approximately USD 5.5 billion, with iodinated contrast media accounting for about 65% of this figure.

What Are the Key Revenue and Sales Trends for AMIPAQUE?

As a branded product, AMIPAQUE has maintained a strong market share in hospitals and imaging centers, especially in Europe and parts of Asia. The global sales of iohexol products were estimated at USD 900 million in 2022. Growth drivers include:

• Increasing prevalence of chronic diseases demanding diagnostic imaging.
• Technological advancements in imaging modalities.
• Expanding use in developing economies due to improved healthcare access.

Market competition intensifies with other iodinated contrast agents such as iohexol's competitors (Omnipaque, Visipaque). Price sensitivity and healthcare reimbursement policies influence sales volumes.

What Are the Dynamics of Patent Protection and Regulatory Status?

AMIPAQUE’s active ingredient, iohexol, has faced patent expirations globally over the past decade. Generic versions entered markets in regions like Europe and Asia from 2014 onwards. Original formulations for AMIPAQUE, depending on jurisdiction, may have patent protection until approximately 2024–2026.

Regulatory hurdles in some markets restrict new entrants or generic versions unless they demonstrate bioequivalence and safety. The regulatory environment impacts investment by influencing potential market exclusivity or increased competition.

How Does Cost Structure Impact Investment Decisions?

Manufacturing costs for contrast media revolve around:

• High-purity chemical synthesis of iohexol.
• Quality assurance and compliance with Good Manufacturing Practice (GMP).
• Distribution logistics for cold chain and sterile packaging.

R&D expenses for innovative formulations or delivery methods typically low given the generic status—unless new delivery systems or formulations are under development. The overall profit margins have been stable but face pressure from generic competition lowering prices.

What Are Future Opportunities and Risks?

Opportunities:

• Launch of new delivery platforms, e.g., pre-filled syringes with increased ease of use.
• Geographic expansion into emerging markets.
• Development of imaging agents with lower osmolality or improved safety profiles.

Risks:

• Entry of generic competitors post-expiry minimizes exclusivity benefits.
• Stringent regulatory changes, notably in safety standards.
• Price erosion driven by increased competition.

What Is the Investment Outlook Based on Fundamentals?

Given AMIPAQUE’s position in a mature but steadily growing market, the immediate investment appeal hinges on:

• Patent status and potential for exclusive sales, which are nearing expiration.
• Market trends favoring expansion into underserved regions.
• Stability of demand owing to the essential nature of contrast agents in diagnostics.

Investors should account for generic competition risk, regulatory landscape, and market penetration potential when evaluating a specific company’s offerings of AMIPAQUE or its equivalents.

What Are Critical Data Points for Valuation?

Metric	2022 Estimate	Commentary
Market size foriodinated contrast media	USD 3.6 billion	2022
Iohexol market share	Approx. USD 900 million	Steady growth
Patent expiration window	2024–2026	Near term
Manufacturing costs	Variable, margin-dependent	Cost efficiencies influence profitability

Key Takeaways

• AMIPAQUE is a leading iodinated contrast agent with a significant market share.
• Patent expiration in the next 1–2 years may lead to increased generic competition.
• The contrast media market remains robust, but margins face pressure from commoditization.
• Opportunities exist in expanding geographic reach and improving formulations.
• Regulatory changes and pricing policies are primary risks.

FAQs

1. What determines the competitiveness of AMIPAQUE after patent expiry?
Generic rivals with bioequivalent formulations can enter the market, often at lower prices, eroding AMIPAQUE’s market share and margins. Brand loyalty and provider preferences influence retention.

2. How critical are regulatory approvals for ongoing sales?
They are essential; regulatory agencies enforce safety standards and approvals are needed for new formulations or indication extensions. Delays or restrictions can impact revenue streams.

3. What are key factors influencing pricing strategies?
Market competition, regulatory environment, manufacturing costs, and reimbursement policies decide price dynamics. Price erosion post-patent expiry is common.

4. Are there emerging markets worth targeting for expansion?
Yes. Countries in Asia-Pacific and Latin America exhibit increasing demand for diagnostic imaging, making them attractive targets for market growth.

5. How do safety concerns with contrast media affect the market?
Safety issues, such as contrast-induced nephropathy, lead to regulatory scrutiny and demand for safer agents, prompting innovations with lower osmolality and improved safety profiles.

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Sources

1. MarketsandMarkets. Contrast Media Market, 2022.
2. FDA and EMA regulatory publications on contrast agents.
3. IQVIA data on contrast media sales, 2022.
4. Global Data Healthcare Reports, 2022.
5. Company filings and patent databases.