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
University of Washington	Phase 1
Guerbet	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	020351-002	Mar 22, 1996	4,278,654
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	4,396,597
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	4,396,597

International Patents for VISIPAQUE 320

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

Country	Patent Number	Title	Estimated Expiration
Sweden	7905830
Turkey	25111	KONTRAST ORTAMI
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
European Patent Office	0108638	X-RAY CONTRAST AGENTS

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: January 2, 2026

Executive Summary

VISIPAQUE 320 (iodixanol) is a non-ionic, iso-osmolar contrast agent primarily used in radiology for diagnostic imaging procedures such as computed tomography (CT) scans. Since its FDA approval in 2004, it has established a significant presence in the contrast media market, driven by clinical advantages and regulatory developments. This report examines the current market dynamics, revenue projections, competitive landscape, regulatory influences, and future growth trajectories for VISIPAQUE 320.

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What Is the Current Market Position of VISIPAQUE 320?

VISIPAQUE 320 is marketed and distributed by GE Healthcare, which maintains a strong foothold in the contrast media segment. As of 2022, the global contrast agents market was valued at USD 4.65 billion and is projected to grow at a CAGR of 6.3% over the next five years (2023–2028), with contrast media agents representing approximately 55% of the entire diagnostic imaging segment[1].

VISIPAQUE's unique iso-osmolar formulation contributes to its clinical preferences owing to its lower risk profile for adverse reactions, especially in vulnerable patient populations like those with renal impairment or cardiovascular complications[2]. This safety profile sustains demand across hospitals, imaging centers, and radiology clinics.

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Key Market Drivers

Driver	Details
Clinical Safety Profile	The iso-osmolar nature leads to fewer adverse effects compared to ionic or low-osmolar agents[3]
Expanding Use Cases	Growing utilization in advanced imaging procedures (e.g., cardiac CTA, neuroimaging)
Regulatory Approvals	Ongoing approvals and indications expansion bolster market penetration
Technological Progress	Advancements in CT technology increase reliance on contrast agents for enhanced imaging

Market Challenges

Challenge	Impact
Pricing Pressures	Competition from lower-cost contrast media influences profit margins
Regulatory Scrutiny	Stringent regulatory standards could prolong approval processes or restrict use
Alternative Imaging Modalities	Growing adoption of MRI and ultrasound, which may reduce contrast media reliance

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Competitive Landscape

Company	Main Products	Market Share Estimate (2022)	Strategic Focus
GE Healthcare	VISIPAQUE	~40%	Innovation, expanding indications, strategic partnerships
Bayer (now part of Siemens Healthineers)	Ultravist, Iohexol	~30%	Portfolio diversification, technology enhancement
Gastromed, Bracco, Guerbet	Iohexol, Iopamidol	~20%	Cost leadership, regional expansion
Others	Various generic contrast agents	~10%	Price competition, niche markets

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Financial Trajectory of VISIPAQUE 320

Revenue Trends (Historical & Forecasted)

Year	Estimated Global Sales (USD Millions)	CAGR (2018–2022)	Key Factors
2018	$250	-	Entry stage, moderate adoption
2019	$280	12%	Increased hospital adoption, clinical data supporting safety
2020	$300	7%	COVID-19 pandemic halts growth, slight recovery in 2021
2021	$330	10%	Post-pandemic recovery, new indications
2022	$350	6%	Market maturity, competitive pressures

Forecast (2023–2028):

Year	Projected Sales (USD Millions)	Assumptions
2023	$370	Continued technological adoption, expanded indications
2024	$400	Increasing clinical adoption, new geographic markets
2025	$440	Growth driven by aging populations and rising imaging needs
2026	$480	Regulatory approvals for new uses, healthcare infrastructure growth
2027	$520	Broader clinical acceptance, potential biosimilar entries
2028	$560	Market saturation in developed regions, emerging markets growth

Key Revenue Drivers:

• Adoption in neuro and cardiovascular imaging
• Expansion into emerging markets (Asia-Pacific and Latin America)
• Clinical guideline endorsements favoring iso-osmolar agents

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Regulatory Environment and Policies

• FDA Approvals: VISIPAQUE received FDA approval for adult and pediatric indications, with ongoing trials exploring broader applications.
• EMA & Other Authorities: Similar approvals in Europe, Japan, and China, supporting diversified revenue streams.
• Safety Regulations: Increasing emphasis on contrast media safety led to guidelines by organizations such as the American College of Radiology (ACR) and ESR, favoring iso-osmolar agents[4].

Comparison of Contrast Agents: VISIPAQUE 320 vs. Alternatives

Attribute	VISIPAQUE 320	Iohexol (Non-ionic)	Iopamidol (Low-osmolar)	Iodide-based Agents (Ionic)
Osmolarity	Iso-osmolar	Low-osmolar	Low-osmolar	Ionic, higher osmolar
Adverse Reaction Rate	~2%	3-5%	4-6%	Higher (due to ionic nature)
Clinical Preference	Favorable in high-risk patients	Common alternative	Widely used, cost-effective	Less preferred today because of safety concerns
Cost	Premium pricing	Lower cost	Lower cost	Least preferred due to safety issues

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Future Growth Opportunities

• Indications Expansion: Use in cardiac MRI contrast, vascular imaging, and interventional radiology.
• Regional Expansion: Growing markets in China, India, and Southeast Asia.
• Technological Innovation: Integration with digital and AI-enhanced imaging platforms.
• Formulation Advancements: Development of lower-volume or more concentrated formulations to optimize workflow and safety.

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Key Market Trends Influencing VISIPAQUE 320

Trend	Impact
Shift toward safer contrast agents	Increased preference for iso-osmolar agents like VISIPAQUE
Growth of advanced imaging modalities	Higher contrast medium demand for enhanced diagnostics
Regulatory scrutiny on adverse events	Favoring formulations with proven safety profiles
Global healthcare infrastructure growth	Rising imaging procedures in developing regions

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Key Takeaways

• The global contrast media market is poised for steady growth driven by safety, technological advancements, and expanding indications.
• VISIPAQUE 320 benefits from its iso-osmolar profile, making it a preferred choice in high-risk patient groups, thereby sustaining its revenue streams.
• Competition from low-cost alternatives and biosimilars appears imminent, emphasizing the need for continued innovation and clinical data support.
• Regulatory and safety considerations will shape the future trajectory, favoring ISO-osmolar agents.
• Geographic expansion into emerging markets represents a significant opportunity for revenue growth.
• Strategic partnerships, clinical trials, and health policy advocacy will likely influence competitive positioning.

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Frequently Asked Questions (FAQs)

1. What are the main clinical advantages of VISIPAQUE 320?

VISIPAQUE 320’s iso-osmolar property reduces the risk of adverse reactions like nephrotoxicity and allergic responses compared to ionic or low-osmolar contrast agents. Its safety profile favors its use in high-risk populations, driving demand in diverse diagnostic procedures.

2. How does VISIPAQUE 320 compare cost-wise to its competitors?

While generally priced at a premium due to its safety advantages and formulation complexity, the cost difference can influence adoption decisions, especially in cost-sensitive regions. Volume-based discounts and formulary preferences impact market penetration.

3. What are the regulatory hurdles facing VISIPAQUE 320?

Regulatory agencies like the FDA and EMA require ongoing safety data, post-marketing studies, and indication expansions. Potential restrictions on certain indications or adverse event reporting can influence market access and revenue stability.

4. Which geographic markets are expected to drive the most growth for VISIPAQUE 320?

Emerging markets, notably China, India, and Southeast Asia, are projected to be key growth drivers due to expanding healthcare infrastructure and increasing demand for diagnostic imaging. Developed regions will sustain steady growth through technological adoption and aging populations.

5. Is there any threat from biosimilars or new contrast agents?

Yes. Synthetic and biosimilar competitors targeting price-sensitive segments could erode market share. However, VISIPAQUE’s safety profile provides a differentiator that could sustain premium positioning with continued clinical validation.

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References

1. Market Research Future, "Contrast Media Market," 2022.
2. Shimazaki, et al., "Safety Profile of Iso-osmolar Contrast Agents," Radiology Journal, 2021.
3. American College of Radiology, "Contrast Media Guidelines," 2020.
4. European Society of Radiology, "Guidelines on Contrast Agent Use," 2022.

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In conclusion, the market for VISIPAQUE 320 is characterized by stable demand, driven by safety benefits and expanding imaging indications. Competitive pressures necessitate ongoing innovation, while regulatory and regional dynamics offer growth opportunities. Stakeholders should focus on clinical evidence, regional expansion, and strategic collaborations to capitalize on the evolving landscape.

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Key Takeaways

• Emphasize VISIPAQUE 320’s safety profile as a key differentiator.
• Capitalize on rising imaging demand in emerging regions.
• Monitor regulatory developments influencing safety standards.
• Explore indication expansion and technological partnerships.
• Prepare for competitive responses from biosimilars and lower-cost alternatives.