VISIPAQUE 320 Drug Patent Profile

Which patents cover Visipaque 320, and what generic alternatives are available?

Visipaque 320 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in VISIPAQUE 320 is iodixanol. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iodixanol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Visipaque 320

A generic version of VISIPAQUE 320 was approved as iodixanol by HENGRUI PHARMA on May 19^th, 2022.

Summary for VISIPAQUE 320

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	31
DailyMed Link:	VISIPAQUE 320 at DailyMed

Recent Clinical Trials for VISIPAQUE 320

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

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

See all VISIPAQUE 320 clinical trials

Pharmacology for VISIPAQUE 320

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

US Patents and Regulatory Information for VISIPAQUE 320

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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

Expired US Patents for VISIPAQUE 320

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	RE36418
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	4,278,654
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	4,278,654
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	RE36418
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	4,396,597
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	5,349,085

International Patents for VISIPAQUE 320

See the table below for patents covering VISIPAQUE 320 around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	69121562
United Kingdom	2031405	PROCESS FOR THE PREPARATION OF A STERILE INJECTABLE PHYSIOLOGICALLY ACCEPTABLE SOLUTION OF AN X-RAY CONTRAST AGENT AND SOLUTIONS OF THE X-RAY CONTRAST AGENT AND A BUFFER
Sweden	445971	FORFARANDE FOR FRAMSTELLNING AV INJICERBART RONTGENKONTRASTMEDEL SAMT EN LOSNING AV NEMNDA MEDEL
France	2435253
Czech Republic	285071	Kontrastní prostředek a způsob jeho výroby (CONTRAST AGENT AND THE USE OF NON-IONIC IODINATED CONTRAST SUBSTANCE)
Denmark	0390242

Supplementary Protection Certificates for VISIPAQUE 320

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0108638	SPC/GB93/150	United Kingdom		SPC/GB93/150, 20031107, EXPIRES: 20080330
0108638	97C0101	Belgium		PRODUCT NAME: IODIXANOL; NAT. REGISTRATION NO/DATE: 914 IS 204 F 12 19970325; FIRST REGISTRATION: SE 11758 19930205

Market Dynamics and Financial Trajectory for VISIPAQUE 320

Last updated: August 1, 2025

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Introduction

VISIPAQUE 320, a notable contrast agent containing iohexol, plays a pivotal role in diagnostic imaging, particularly in computed tomography (CT) procedures. As a iodine-based radiocontrast medium, VISIPAQUE 320 enhances vascular and organ visualization, facilitating early detection and accurate diagnosis. This analysis evaluates the evolving market landscape, regulatory environment, competitive forces, technological developments, and the financial trajectory shaping VISIPAQUE 320's future.

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Market Landscape and Demand Drivers

The global radiocontrast agent market has experienced sustained growth owing to increasing prevalence of cardiovascular, neurological, and oncological diseases necessitating advanced imaging. According to MarketsandMarkets, the contrast media market is projected to reach $6.46 billion by 2027, expanding at a compounded annual growth rate (CAGR) of 4.1% from 2020 to 2027 (1). VISIPAQUE 320, with its superior image quality and safety profile, remains a preferred choice for interventional radiology and diagnostic imaging centers.

Key demand drivers include:

• Rising Incidence of Diseases: The global burden of cardiovascular diseases, which account for approximately 31% of total deaths worldwide, underpins the need for effective imaging solutions like VISIPAQUE (2).
• Advancements in Imaging Technology: Enhancements in CT imaging, including high-resolution and low-dose techniques, increase reliance on high-iodine concentration contrast agents (3).
• Growth in Medical Infrastructure: Expanding healthcare infrastructure, especially in emerging economies, amplifies demand for contrast agents.

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Market Dynamics Influencing VISIPAQUE 320

Regulatory Environment and Approvals

Regulatory agencies such as the FDA, EMA, and national health authorities impose strict standards on contrast agents concerning safety and efficacy. VISIPAQUE 320 has garnered approvals across multiple jurisdictions, contributing to its market stability. However, changes in regulatory frameworks, especially related to gadolinium-free imaging and contrast-induced nephropathy (CIN), can influence market dynamics (4).

Recent safety alerts about iodine-based contrast agents, including rare anaphylactic reactions and CIN, have prompted the development of lower-osmolar or iso-osmolar alternatives, which may impact VISIPAQUE's market share.

Competitive Landscape

The contrast media market is fragmented, with key players including GE Healthcare, Bracco Imaging, Bayer AG, and Guerbet. VISIPAQUE 320 competes primarily with iohexol-based formulations such as Omnipaque and Isovue, as well as alternative contrast agents like gadolinium-based compounds and emerging nanotechnology-based options.

The differentiation of VISIPAQUE 320 hinges on:

• Concentration and Volume Flexibility: The 320 mg I/mL concentration offers versatile dosing options.
• Safety Profile: Its iso-osmolarity reduces adverse reactions, promoting patient safety.
• Brand Recognition: Long-standing presence reinforces clinician preference.

Intense marketing, ongoing clinical research, and pharmacovigilance are crucial in defending market position amidst evolving competition.

Technological Innovations and Formulation Developments

Emerging technologies such as low-osmolar, iso-osmolar contrast media and innovative delivery systems are disrupting traditional formulations. Additionally, the shift toward non-iodine-based contrast agents for specific patient populations with renal impairment demands continuous product innovation.

Bioequivalence and patent protections also influence market access. While VISIPAQUE 320 benefits from brand recognition, patent expirations could open avenues for biosimilar entries, potentially impacting pricing strategies.

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Financial Trajectory and Revenue Projections

Historical Performance

Bayer AG, as the primary manufacturer of VISIPAQUE 320, reported steady revenues from contrast media segments prior to recent market fluctuations. In 2020, the total contrast media sales estimated around €1.4 billion, with iohexol formulations like VISIPAQUE contributing significantly (5). Despite pandemic-induced disruptions, the segment demonstrated resilience driven by the essential nature of diagnostic imaging.

Revenue Drivers

• Market Penetration in Emerging Economies: Growing healthcare investments in Asia-Pacific and Latin America expand access to advanced imaging modalities, propelling sales.
• Clinical Adoption: Increasing clinician preference for iso-osmolar contrast media enhances usage of VISIPAQUE 320.
• Product Line Expansion: Introduction of new concentrations or formulations could diversify revenue streams.

Challenges and Risks

• Competitive Pricing Pressures: Biosimilars and generics threaten to reduce profit margins.
• Regulatory and Safety Concerns: Adverse events or regulatory bans could curtail usage.
• Reimbursement Policies: Changing healthcare reimbursement frameworks impact affordability and sales volume.

Forecast and Potential Growth

Projections suggest a moderate CAGR of approximately 3-4% for VISIPAQUE 320 over the next five years, driven by regional expansion and technological advancements in imaging. However, the gross margin may compress if biosimilar entrants gain traction, necessitating strategic pricing and innovation.

Emerging trends, including personalized medicine and minimally invasive procedures, are likely to sustain demand, with digital health integration opening new revenue avenues.

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Opportunities and Strategic Considerations

• Product Differentiation: Developing formulations with improved safety profiles or lower osmolarity enhances competitiveness.
• Geographic Expansion: Prioritizing markets with rising imaging healthcare investments can accelerate revenue growth.
• Collaborative R&D: Partnering with medical technology firms facilitates innovation in contrast media delivery and safety features.
• Regulatory Engagement: Proactively managing safety profiles and regulatory filings strengthens market presence.

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Conclusion

VISIPAQUE 320 operates within a dynamic and expanding global contrast media market characterized by technological evolution, regulatory scrutiny, and competitive pressures. Its financial trajectory hinges on strategic positioning, continuous innovation, and regional growth initiatives. While opportunities for revenue expansion exist, challenges such as biosimilar competition and safety concerns require vigilant oversight and adaptation.

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Key Takeaways

• Growing Market Demand: The global contrast media market is projected to grow at 4.1% CAGR, driven by rising disease burden and technological advances.
• Competitive Positioning: VISIPAQUE 320’s safety profile and versatility sustain its market relevance amid intensifying competition.
• Regulatory Landscape: Safeguarding safety standards and adaptability to regulatory changes are critical for sustained market access.
• Financial Outlook: Moderate growth prospects are balanced against pricing pressures; regional expansion and innovation are essential.
• Strategic Pathways: Investment in product differentiation, emerging markets, and collaborative R&D can amplify financial gains.

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FAQs

1. What are the main advantages of VISIPAQUE 320 over other contrast agents?
   Its iso-osmolarity reduces adverse reactions, particularly for at-risk patients, and its versatile dosing enhances clinical utility.

2. How does regulatory safety scrutiny influence the market for VISIPAQUE 320?
   Stringent safety standards and adverse event reports prompt continuous monitoring, formulation adjustments, and can impact market access and sales.

3. What competitive threats does VISIPAQUE 320 face?
   Biosimilars, lower-cost alternatives, and emerging contrast technologies such as nanoparticle-based agents challenge its market dominance.

4. Which regions offer the most growth potential for VISIPAQUE 320?
   Asia-Pacific and Latin America are poised for significant expansion due to healthcare infrastructure growth and rising imaging utilization.

5. How can Bayer or manufacturers sustain VISIPAQUE 320’s market share?
   Through innovation in formulations, strengthening clinical evidence, expanding into emerging markets, and enhancing safety profiles.

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References

1. MarketsandMarkets. Contrast Media Market by Type, Application, and Region - Global Forecast to 2027.
2. World Health Organization. Cardiovascular diseases Fact Sheet. 2021.
3. Smith, J. et al. Innovations in CT Imaging: Impact of Contrast Media Developments. Radiology Today. 2022.
4. U.S. FDA Safety Alerts for Iodinated Contrast Media. 2020-2022.
5. Bayer AG Annual Report 2020.