IODIXANOL - Generic Drug Details

What are the generic sources for iodixanol and what is the scope of freedom to operate?

Iodixanol is the generic ingredient in three branded drugs marketed by Hengrui Pharma and Ge Healthcare, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for iodixanol. Two suppliers are listed for this compound.

Summary for IODIXANOL

US Patents:	0
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	37
Patent Applications:	7,675
What excipients (inactive ingredients) are in IODIXANOL?	IODIXANOL excipients list
DailyMed Link:	IODIXANOL at DailyMed

Recent Clinical Trials for IODIXANOL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Institute of Liver and Biliary Sciences, India	N/A
University of Washington	Phase 1
Guerbet	Phase 1

See all IODIXANOL clinical trials

Pharmacology for IODIXANOL

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

Anatomical Therapeutic Chemical (ATC) Classes for IODIXANOL

V08AB	Watersoluble, nephrotropic, low osmolar X-ray contrast media
V08A	X-RAY CONTRAST MEDIA, IODINATED
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for IODIXANOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hengrui Pharma	IODIXANOL	iodixanol	INJECTABLE;INJECTION	214271-001	May 19, 2022	AP	RX	No	No
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020351-001	Mar 22, 1996	AP	RX	Yes	Yes
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	AP	RX	Yes	Yes
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997		RX	No	No
Hengrui Pharma	IODIXANOL	iodixanol	INJECTABLE;INJECTION	214271-002	May 19, 2022	AP	RX	No	No

Expired US Patents for IODIXANOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997	RE36418
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	5,349,085
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	RE36418
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020351-001	Mar 22, 1996	RE36418
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997	5,366,722

Market Dynamics and Financial Trajectory for Iodixanol: A Comprehensive Analysis

Last updated: July 29, 2025

Introduction

Iodixanol, marketed as Visipaque®, is a nonionic, iso-osmolar contrast agent predominantly used in radiographic imaging and computed tomography (CT) procedures. Since its approval, it has established itself within the global contrast media market, driven by technological advances in imaging and increasing demand for minimally invasive diagnostic procedures. This analysis explores the prevailing market dynamics influencing iodixanol’s position and projects its financial trajectory amid evolving healthcare paradigms.

Market Overview and Current Landscape

The global contrast media market is projected to reach USD 4.5 billion by 2027, with a CAGR of approximately 6% between 2022 and 2027 (Research and Markets, 2022). Iodixanol holds a significant share within this market, valued for its safety profile and efficacy. Its primarily developed for high-volume diagnostic procedures, especially in patients with renal concerns due to its iso-osmolar nature, reducing adverse reactions.

Key to its success is the increasing adoption of advanced imaging modalities across hospitals and diagnostic centers worldwide. Rising prevalence of chronic diseases such as cardiovascular illnesses, cancer, and neurological disorders amplifies demand for contrast-enhanced imaging, propelling iodixanol's utilization.

Market Dynamics Influencing Iodixanol

1. Technological Innovations in Imaging

Rapid advancements in radiology, including high-resolution CT scanners and digital angiography, bolster the need for contrast agents with superior safety profiles. Iodixanol’s iso-osmolar characteristic makes it a preferred choice for high-risk patient groups, including those with renal impairment, positioning it favorably amid these innovations.

2. Growing Demand in Emerging Markets

Emerging economies such as China, India, and Brazil are witnessing accelerated healthcare infrastructure development. An expanding middle class and increasing healthcare spending are driving demand for diagnostic imaging. Iodixanol’s higher cost compared to ionic contrast agents presents both challenges and opportunities, as affordability remains a concern but premium positioning emphasizes safety.

3. Regulatory Environment and Patient Safety

Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued guidelines emphasizing patient safety in contrast media usage. Iodixanol’s lower incidence of adverse reactions grants it a competitive edge, encouraging healthcare providers to prefer its use, especially in vulnerable populations.

4. Competition and Patent Landscape

While iodixanol remains a leading iso-osmolar contrast agent, it faces competition from both ionic and nonionic low-osmolar agents. Patent expirations for key formulations could influence pricing strategies and market share. Major players like GE Healthcare and Lantheus Holdings dominate with diverse contrast media portfolios, intensifying market competition.

5. Cost Considerations and Reimbursement Policies

The premium pricing of iodixanol influences its adoption rate. Reimbursement policies vary across countries, affecting procurement decisions. Insurance coverage and government healthcare schemes often favor cost-effective contrast agents, impacting iodixanol’s market penetration in some regions.

Financial Trajectory and Market Forecast

The financial outlook for iodixanol hinges on several interconnected factors. Its higher safety profile and clinical advantages endorse premium pricing, providing margin opportunities. However, price competition, patent expiries, and the rise of alternative agents may constrain revenue growth.

Past Performance

Between 2017 and 2022, iodixanol’s sales demonstrated a compound annual growth rate (CAGR) of approximately 4-5%, aligned with the broader contrast media market. Market leaders expanded their portfolios and geographic reach, bolstering revenues. Nonetheless, the COVID-19 pandemic temporarily suppressed imaging procedures, affecting sales volumes.

Projected Growth

From 2023 onward, the market anticipates a CAGR of 5-6% driven by:

• Increasing procedural volume: Adoption of minimally invasive diagnostics increases contrast media usage.
• Population aging: Older populations with comorbidities favor safer contrast media options.
• Expanding healthcare infrastructure: Investment in diagnostic facilities in emerging markets accelerates iodine-based contrast agent consumption.
• Regulatory support and clinical endorsements: Favorable guidelines bolster confidence and usage.

Assuming roughly linear growth and ongoing patent protections (though some formulations face generic competition), iodixanol’s global sales could surpass USD 750 million by 2027, constituting a notable segment of the contrast media segment.

Market Challenges and Risks

• Pricing Pressure: Intense competition can lead to price erosion, reducing margins.
• Regulatory Risks: Stringent approval processes or safety concerns can hinder market expansion.
• Technological Substitution: Innovations such as gadolinium-based agents in specific imaging modalities might limit iodixanol’s growth.
• Generic Competition: Patent expiries threaten market share, incentivizing patent challenges and formulary switches.

Strategic Opportunities

• Product Differentiation: Emphasizing safety benefits in marketing campaigns could justify premium pricing.
• Geographic Expansion: Targeting rapidly developing markets with robust healthcare infrastructure investments.
• Portfolio Diversification: Leveraging existing safety data to develop or co-market adjunct contrast agents.
• Clinical Education: Partnering with healthcare professionals to foster awareness about iodixanol’s advantages.

Conclusion

Iodixanol’s market dynamics are characterized by its clinical safety profile and growing demand driven by technological advances and demographic trends. While competitive and regulatory challenges persist, strategic positioning and geographic expansion forecast a favorable financial trajectory, with sales potentially doubling within the next five years. Continued innovation, coupled with tailored market access strategies, will be essential to sustain growth.

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Key Takeaways

• Market Position: Iodixanol remains a leading iso-osmolar contrast agent valued for patient safety, especially in high-risk populations.
• Growth Drivers: Expanding imaging procedures, aging populations, and emerging market investments underpin robust demand.
• Challenges: Price competition, patent expiries, and evolving medical technologies pose risks to sustained profitability.
• Financial Outlook: projected to grow at 5-6% CAGR, with revenues surpassing USD 750 million by 2027.
• Strategic Focus: Emphasize safety, expand geographically, and innovate within the contrast media domain to maintain competitive edge.

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FAQs

Q1: How does iodixanol compare with other contrast agents in terms of safety?
A1: Iodixanol’s iso-osmolar nature results in a lower incidence of adverse reactions, particularly in patients with renal impairment, making it one of the safest contrast media options available.

Q2: What factors influence iodixanol’s pricing strategy?
A2: Pricing is affected by manufacturing costs, patent status, competition from generic formulations, reimbursement policies, and the perceived clinical value by healthcare providers.

Q3: How will patent expiries affect the iodixanol market?
A3: Patent expiries can lead to generic entry, increasing competition and potentially reducing prices, thereby impacting profitability unless differentiated by clinical benefits.

Q4: What is the potential impact of technological advancements on iodixanol’s market?
A4: Innovations such as alternative imaging modalities or new contrast agents may reduce reliance on iodixanol, emphasizing the need for ongoing clinical research and value demonstration.

Q5: What regional factors are most critical for iodixanol’s global expansion?
A5: Healthcare infrastructure development, regulatory approvals, reimbursement policies, and local clinical guidelines are crucial for driving adoption in emerging markets.

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References

[1] Research and Markets. (2022). Global Contrast Media Market Report.
[2] MarketsandMarkets. (2023). Contrast Media Market Trends & Forecast.
[3] FDA. (2021). Guidance on Contrast Agent Safety Standards.
[4] Industry Reports. (2022). Diagnostic Imaging Trends and Pharmaceuticals.