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
Germany	2031724
Netherlands	153083
Belgium	752574
Sweden	411750	AMIDBILDANDE BENSOESYRADERIVAT TILL ANVENDNING SASOM MELLANPRODUKTER VID FRAMSTELLNING AV 3,5-DISUBSTITUERADE 2,4,6-TRIJODBENSAMIDER
Denmark	130709
Sweden	392100	TRIJODBENSOYLAMINER TILL ANVENDNING SASOM RONTGENKONTRASTMEDEL ELLER FOR SEPARATION AV BIOLOGISKA MATERIAL

Market Dynamics and Financial Trajectory for AMIPAQUE

Last updated: July 31, 2025

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Introduction

AMIPAQUE, the trade name for ioxitalamate, is a contrast agent primarily used in diagnostic imaging procedures such as computed tomography (CT) scans. Its unique pharmacological profile, safety profile, and clinical efficacy have positioned it as a notable player within the radiology contrast agent segment. This analysis assesses the market landscape, drivers, barriers, and the financial outlook for AMIPAQUE within this competitive environment.

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Market Overview

Global Contrast Agent Market Landscape

The global radiology contrast agents market is witnessing exponential growth, driven by increasing prevalence of chronic diseases requiring advanced imaging, technological innovations, and expanding healthcare infrastructure. According to industry reports, the contrast agents market was valued at approximately USD 4.4 billion in 2021, with a projected compound annual growth rate (CAGR) of around 4% through 2028 [1].

Positioning of AMIPAQUE

AMIPAQUE holds a segment in the iodinated contrast agent sector, often distinguished for its high image quality and favorable safety profile. Although not as dominant as key players like GE Healthcare’s Omnipaque or Bayer’s Ultravist, AMIPAQUE’s niche positioning caters to specific clinical settings, especially where nephrotoxicity mitigation or ultra-high resolution imaging is prioritized.

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Market Drivers

Growing Demand for Advanced Imaging Modalities

The proliferation of diagnostic imaging, especially CT scans, fuels the demand for contrast agents. As medical imaging becomes integral to early diagnosis and treatment of diseases such as cancer, cardiovascular disorders, and neurological conditions, contrast agents like AMIPAQUE are essential.

Expanding Healthcare Infrastructure and Accessibility

Emerging economies investing in healthcare infrastructure are increasing access to imaging solutions. Government initiatives, investments, and healthcare digitization improve utilization rates for contrast agents.

Technological Innovations and Safer Contrast Formulations

Advancements in contrast agent formulations, such as reduced osmolality and improved safety profiles, make agents like AMIPAQUE attractive for high-risk patient populations, including those with renal impairment or allergies.

Regulatory Approvals and Clinical Evidence

Regulatory approvals leveraging robust clinical data favor market acceptance. AMIPAQUE's safety and efficacy evidence support its adoption in diverse clinical settings, meeting stringent health authority standards across regions.

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Market Barriers and Challenges

High Competition and Branding Dominance

The contrast agent market is highly consolidated, with major players commanding significant market share through aggressive marketing, extensive distribution networks, and established clinical trust.

Pricing Pressures and Reimbursement Dynamics

Pricing strategies are sensitive, with payers demanding cost-effective solutions. Reimbursement policies influence the adoption rate and profitability margins for pharmaceutical companies offering contrast agents like AMIPAQUE.

Concerns Over Adverse Reactions

Despite safety profiles, iodinated contrast agents carry risks such as contrast-induced nephropathy (CIN). Heightened awareness and risk mitigation protocols could limit usage, particularly in vulnerable populations.

Regulatory Hurdles

Region-specific regulatory requirements and delays in approvals can impede market penetration and future product launches.

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Financial Trajectory and Commercial Outlook

Current Revenue Streams

Given its niche positioning, AMIPAQUE’s revenue is primarily driven by high-volume imaging centers and hospitals catering to specialties like oncological imaging and cardiovascular diagnostics. Its revenue contribution is relatively modest compared to global giants but is solid within its targeted markets.

Growth Projections

Over the short term (up to 2025), moderate growth is anticipated, aligned with overall contrast agent market growth, assuming steady healthcare expansion and technological adoption. In emerging markets, the growth rate may accelerate owing to infrastructure investments and increasing disease burden [2].

Strategic Investment and Market Expansion

Pharmaceutical companies may pursue strategic collaborations, licensing deals, or manufacturing optimizations to expand AMIPAQUE’s geographic reach. Enhanced positioning in underserved markets like Latin America, Southeast Asia, and Africa could significantly impact financial performance.

Impact of Regulatory and Clinical Developments

Enhanced safety profiles, new clinical applications, or regulatory approvals for specific indications could catalyze revenue growth. Conversely, adverse regulatory decisions or setbacks may diminish financial prospects.

Innovation and Pipeline Developments

Investment in formulation improvements—such as lower osmolality or alternative delivery methods—could extend AMIPAQUE’s market life and improve profitability by differentiating from competitors.

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Future Outlook and Strategic Considerations

The trajectory of AMIPAQUE hinges on multiple factors:

• Market Penetration: Focused efforts in expanding clinical adoption and hospital partnerships will be critical.
• Regulatory Landscape: Navigating diverse regulatory environments efficiently enhances international sales prospects.
• Innovation Initiatives: Developing next-generation contrast agents with superior safety and efficacy profiles will be a competitive advantage.
• Pricing Strategies: Balancing affordability with profitability amidst reimbursement pressures is essential.

In the broader context, the contrast agents segment is projected to grow steadily, buoyed by global healthcare investments and diagnostic imaging advancements. AMIPAQUE’s prospects are favorable if positioned strategically within this expanding landscape.

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Key Takeaways

• Market growth prospects are favorable, driven by the increasing global demand for advanced diagnostic imaging and technological innovations.
• Competition remains fierce, necessitating strategic differentiation, particularly around safety and efficacy features.
• Healthcare infrastructure development in emerging markets offers significant growth opportunities for AMIPAQUE’s commercial expansion.
• Regulatory navigation and clinical evidence will be pivotal in shaping AMIPAQUE’s future market access and reimbursement landscape.
• Innovation in formulation or delivery can extend its market lifecycle and improve profitability.

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FAQs

1. What distinguishes AMIPAQUE from other iodinated contrast agents?
   AMIPAQUE is noted for its safety profile, specifically in reducing the risk of contrast-induced nephropathy, making it suitable for high-risk patients.

2. How does the regulatory environment impact AMIPAQUE’s marketability?
   Regulatory approvals in key regions, based on robust clinical data, are essential for market entry. Regulatory delays can hamper sales growth and global expansion.

3. What are the primary clinical applications of AMIPAQUE?
   Its main applications include contrast-enhanced CT scans for cardiovascular, oncological, and neurological imaging where high image clarity and patient safety are priorities.

4. Which markets offer the most growth potential for AMIPAQUE?
   Emerging markets in Asia, Latin America, and Africa, where healthcare infrastructure investments are increasing, present significant growth opportunities.

5. How can AMIPAQUE maintain competitiveness amid dominant players?
   Through strategic innovation, clinic-centric marketing, cost-effective supply chains, and expanding indications — particularly emphasizing safety and patient outcomes.

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References

[1] IndustryARC, "Global Contrast Agents Market Analysis & Trends," 2022.
[2] MarketWatch, "Diagnostic Imaging Market Forecast," 2023.