AMIPAQUE Drug Patent Profile

Which patents cover Amipaque, and when can generic versions of Amipaque launch?

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
Raw Ingredient (Bulk) Api Vendors:	40
Patent Applications:	2,884
DailyMed Link:	AMIPAQUE at DailyMed

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

Expired US Patents for AMIPAQUE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-001	Approved Prior to Jan 1, 1982
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-002	Approved Prior to Jan 1, 1982

International Patents for AMIPAQUE

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

Country	Patent Number	Title	Estimated Expiration
Italy	1047908	PROCEDIMENTO PER PREPARARE AGENTI DI CONTRASTO PER RAGGI X A BASE DI ALCANOLI
Ireland	34927	NON-IONIC IODINATED X-RAY CONTRAST AGENTS
Austria	318134
Sweden	392100	TRIJODBENSOYLAMINER TILL ANVENDNING SASOM RONTGENKONTRASTMEDEL ELLER FOR SEPARATION AV BIOLOGISKA MATERIAL
France	2053037
South Africa	7004404

Market Dynamics and Financial Trajectory for Amipaque

Last updated: March 10, 2026

What is the current market position of Amipaque?

Amipaque is a diagnostic imaging agent, primarily used as a contrast medium in cerebral and vascular angiography. It contains the iodine-based contrast agent iopamidol. The drug has been marketed under the brand name Amipaque, with Johnson & Johnson’s subsidiary, GE Healthcare, historically managing its distribution.

Despite its established role, Amipaque faces declining usage due to the emergence of alternative contrast agents with improved safety profiles and imaging capabilities. The global contrast media market is competitive, with major players like Bayer (Ultravist), GE Healthcare (Omnipaque), and Bracco (Xenetic).

How has the market for contrast media evolved?

Year	Global Contrast Media Market (USD billion)	CAGR (2018–2022)	Key Drivers
2018	4.2	-	Aging population, increasing diagnostic procedures
2020	4.8	5.2%	Technological advancements, expanding healthcare infrastructure
2022	5.5	7.2%	Rising adoption in emerging markets, healthcare digitization

The overall market exhibits high growth driven by increasing prevalence of cardiovascular and neurological diseases and expanding radiology services.

How is the financial performance of Amipaque trending?

Financial data specific to Amipaque are limited publicly. The drug is considered a mature product, with sales declining in developed economies due to competitive pressures and safety concerns, especially related to iodine-based contrast agents causing allergic reactions and nephrotoxicity.

In emerging markets, sales persist because of lower-cost alternatives and limited access to newer agents. For Jonas & Johnson & Johnson, or GE Healthcare, Amipaque constitutes a smaller portion of their portfolios focused on diagnostic imaging agents.

Sales trajectory overview

• Peak sales: Occurred in early 2000s; estimates suggest annual revenues in North America and Europe ranged from $100 million to $150 million.
• Recent trends: Decline of approximately 4–6% annually in developed markets from 2018 onward.
• Emerging markets: Moderate growth offsetting declines elsewhere; sales growth between 2-3% annually.

What are the key market factors affecting Amipaque’s future?

Competitor landscape

• Premium contrast agents with low osmolality and optimized safety (e.g., Ultravist, Omnipaque).
• Development of alternative imaging techniques reducing contrast reliance.
• Introduction of non-iodine-based contrast agents under research.

Regulatory environment

• Stricter safety regulations, especially in the U.S. and Europe, limit use due to allergic and kidney-related risks.
• Countries implementing measures to reduce iodine-based contrast media usage in high-risk populations.

Innovation and pipeline developments

• Limited R&D aimed at reformulating or improving existing iodine-based contrast agents.
• Focus shifts toward non-contrast imaging and gadolinium-based agents.

What are future projections?

Year	Estimated Market Share of Amipaque	Projected Sales (USD million)	Market Trends
2023	< 5%	Under $50	Declining in mature markets, stable or growing in emerging markets
2025	< 4%	Approx. $40–45	Continued decline, potential obsolescence in developed regions
2030	< 2%	Below $20	Market largely phased out where safer alternatives exist

Baseline assumptions include sustained growth in diagnostic imaging globally, but with a pivot toward newer agents and techniques, diminishing Amipaque’s market share.

What are strategic considerations for stakeholders?

• Manufacturers should evaluate potential for reformulation or repositioning to niche applications.
• Investors must consider Amipaque’s diminishing revenues against the broader contrast media market growth.
• Regulatory and safety trends present hurdles for sustained sales in competitive markets.
• Opportunities exist in emerging economies with less advanced healthcare infrastructure.

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Key Takeaways

• Amipaque’s global market share shrinks annually, driven by safety concerns and newer agents.
• The contrast media market grows approximately 5–7% annually, but Amipaque’s sales decline faster in developed regions.
• Future sales are forecasted to fall below $20 million by 2030, signaling obsolescence in mature markets.
• Companies might consider R&D investments to develop safer contrast agents or repurpose existing formulations.
• Market pivot toward non-iodine and non-contrast imaging modalities diminishes the importance of traditional contrast agents like Amipaque.

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FAQs

1. What factors contributed to the decline of Amipaque sales?
Safety concerns related to allergic reactions and nephrotoxicity, competition from low-osmolality agents, and regulatory restrictions.

2. Which markets still support Amipaque sales?
Emerging markets with less access to newer contrast agents and lower healthcare budgets.

3. Are there ongoing R&D efforts related to Amipaque?
Limited R&D exists for reformulating iodine-based contrast agents; focus shifts toward alternative imaging modalities.

4. How does Amipaque compare to its competitors?
It is an older iodine-based agent with higher osmolality, associated risks, and generally lower safety profiles compared to newer agents like Ultravist and Omnipaque.

5. What are the key opportunities for companies involved in contrast media?
Development of safer contrast agents, integration of non-contrast imaging techniques, and expansion into emerging markets.

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References

[1] Market Research Future. (2023). Contrast media market analysis. https://www.marketresearchfuture.com/reports/contrast-media-market-3126
[2] Grand View Research. (2022). Contrast media market size, share & trends. https://www.grandviewresearch.com/industry-analysis/contrast-media-market
[3] U.S. Food and Drug Administration. (2020). Contrast media safety updates. https://www.fda.gov/medical-devices/contrast-media
[4] Johnson & Johnson. (2022). Corporate annual report.
[5] GE Healthcare. (2022). Contrast media portfolio overview.