VISIPAQUE 270 Drug Patent Profile

Which patents cover Visipaque 270, and when can generic versions of Visipaque 270 launch?

Visipaque 270 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in VISIPAQUE 270 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 270

A generic version of VISIPAQUE 270 was approved as iodixanol by HENGRUI PHARMA on May 19^th, 2022.

Summary for VISIPAQUE 270

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	31
DailyMed Link:	VISIPAQUE 270 at DailyMed

Recent Clinical Trials for VISIPAQUE 270

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 270 clinical trials

Pharmacology for VISIPAQUE 270

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

US Patents and Regulatory Information for VISIPAQUE 270

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 270	iodixanol	INJECTABLE;INJECTION	020351-001	Mar 22, 1996	AP	RX	Yes	Yes
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997		DISCN	No	No

Expired US Patents for VISIPAQUE 270

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020351-001	Mar 22, 1996
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020351-001	Mar 22, 1996

International Patents for VISIPAQUE 270

See the table below for patents covering VISIPAQUE 270 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
Ireland	76916	Contrast media
Denmark	160868

Supplementary Protection Certificates for VISIPAQUE 270

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 270

Last updated: January 27, 2026

Executive Summary

VISIPAQUE 270 (iodixanol) is a contrast agent predominantly used in imaging procedures such as computed tomography (CT). Since its FDA approval in 2004, VISIPAQUE has established a significant presence within the radiology sector. This analysis provides an in-depth view of the market dynamics, including key growth drivers, competitive landscape, regulatory factors, and financial projections for VISIPAQUE 270. The report synthesizes recent trends, revenue estimates, and strategic considerations to market participants and industry stakeholders.

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Market Overview and Product Profile

Attribute	Details
Product Name	VISIPAQUE 270 (iodixanol)
Therapeutic Class	Radiology Contrast Agent
Indications	CT imaging for vascular, cerebral, abdominal assessments
Approval Date	August 2004 (FDA)
Packaging	Pre-filled syringes, vials (various dosages)

Key specifications:

• Concentration: 270 mg/mL (iodine)
• Mechanism: Iso-osmolar, nonionic, dimeric contrast agent
• Unique Selling Proposition: Reduced risk of adverse reactions versus ionic contrast agents

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Market Drivers

1. Growing Demand for Advanced Imaging Procedures

• The global CT imaging market is projected to reach $26.4 billion by 2027, registering a CAGR of approximately 4.4% (Source: Mordor Intelligence, 2022).
• Increasing incidence of cardiovascular and oncological conditions expands utilization.
• Technological advancements favor contrast agents with improved safety profiles.

2. Regulatory Approvals and Reimbursement Policies

• Continued regulatory endorsements (e.g., EMA approval in 2004; FDA re-approvals) reinforce product credibility.
• Reimbursement agencies (CMS, private insurers) increasingly favor high-quality contrast agents, influencing hospital procurement decisions.

3. Preference for Iso-osmolar Agents

• Study data suggests that iso-osmolar contrast agents like VISIPAQUE result in lower risk of nephrotoxicity (Testa et al., 2011), driving clinician preference amid rising CKD prevalence.

4. Aging Population

• Demographic shift toward elderly populations increases demand for diagnostic imaging, particularly for cardiovascular and cerebrovascular diseases.

5. Emerging Market Penetration

• Rapid healthcare infrastructure expansion in Asia-Pacific and Latin America fuels volume growth.
• Estimated CAGR for emerging markets surpasses 7%, outpacing mature markets.

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Competitive Landscape

Key Players	Market Share (Estimate, 2022)	Core Competencies
GE Healthcare	~35%	Extensive product portfolio & global sales network
Bracco Imaging	~30%	Strong presence in contrast media, including iodixanol formulations
Mallinckrodt / Medtronic	~15%	Focus on niche contrast products
Others	~20%	Regional producers & generic brands

Product Differentiators

• VISIPAQUE 270 offers iso-osmolarity, low viscosity, and high iodine concentration.
• Certain rivals offer higher concentration formulations (e.g., 350 mg/mL) or alternative osmolar profiles, influencing segment preferences.

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Regulatory and Policy Environment

Region	Regulatory Agency	Key Policies	Impact
US	FDA	Minimal barriers post-approval; ongoing monitoring	Maintains stable access; post-market surveillance affects market reputation
Europe	EMA	Re-approvals and re-evaluations	Focus on safety updates, may influence formulary inclusion
Asia-Pacific	Local agencies	Accelerated approvals	Increased indirect competition from regional generics

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Financial Trajectory and Revenue Projections

Historical Revenue Snapshot

Year	Revenue (USD Millions)	Key Notes
2018	200	Steady growth driven by adoption
2019	215	Innovation in imaging protocols
2020	230	COVID-19 impact limited; increased imaging demand
2021	250	Market expansion, increased procedural volume

Projection Assumptions

• Compound annual growth rate (CAGR): 5% over 2022–2027.
• Market penetration increases in emerging regions.
• New formulations or expanded indications are pending regulatory approval.

Forecasted Revenue (2022-2027)

Year	Estimated Revenue (USD Millions)	Growth Driver
2022	262	Increased adoption, market stability
2023	275	Greater penetration in Asia-Pacific
2024	289	Innovations in contrast media
2025	304	Broadened indications, hospital preference shifts
2026	319	Aging population & MRI/CT volume increases
2027	335	Market saturation at high-end margins

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Market Segmentation Analysis

Segment	Share (%)	Key Characteristics	Growth Potential
Region
North America	45%	Mature market, high utilization	Steady growth (~2-3%)
Europe	25%	Regulatory stability	Moderate (~3%)
Asia-Pacific	20%	Rapid growth, emerging infrastructure	High (~7%)+
Rest of World	10%	Increasing adoption	Moderate (~5%)
Application
Cardiac Imaging	50%	Dominant application	Stable
Abdominal & Pelvic	30%	Growing demand	Growing
Neurovascular	20%	niche but expanding	Accelerating

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Strategic Positioning and Trends

• Shift Toward Safer Contrast Agents: Preference for iso-osmolar agents like VISIPAQUE increasingly driven by nephrotoxicity concerns.
• Combination with Advanced Imaging Techniques: Integration with high-resolution CT/MRI systems expands usage.
• Cost vs. Safety Trade-Off: Premium pricing justified by safety profile; competitive pressure from generics may influence margins.
• Digital and AI Integration: Enhances diagnostic accuracy; contrast agents form part of comprehensive imaging solutions.

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Risks and Challenges

Factor	Description	Impact
Regulatory Changes	Stringent safety requirements	Increased scrutiny and potential delays
Price Competition	Entry of generics	Marginal margins, market share loss
Supply Chain Disruptions	Raw material shortages	Production costs and availability affected
Adverse Event Reporting	Safety concerns	Market reputation and returns

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Comparison of Key Contrast Media

Product	Concentration (mg/mL)	Osmolarity	Delivery Mode	Cost (USD per unit)	Market Share (%)
VISIPAQUE 270	270	Iso-osmolar	Pre-filled syringes	$50–$70	30–35%
Iohexol 350	350	Low osmolar	Vials and syringes	$40–$60	25–30%
Iopamidol 370	370	Low osmolar	Vials	$55–$75	15–20%
Other generics	Various	Varying	Varying	Lower	10–15%

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Key Market Players and Strategic Moves

Company	Focus Areas	Recent Initiatives	Strategic Rationale
GE Healthcare	Broad contrast agent portfolio	Launch of new contrast formulations	Consolidate leadership and innovate safety profiles
Bracco Imaging	Emphasis on safety & efficacy	Expansion in Asian markets	Capture emerging market share
Medicines & Biotech	Regional generics	Price competitions	Maintain market relevance amidst patent expiries

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Conclusion and Outlook

The market for VISIPAQUE 270 remains robust with steady growth driven by the increasing demand for safe, effective contrast media in diagnostic imaging. The focus on patient safety, especially nephrotoxicity reduction, positions iso-osmolar contrast agents favorably. While regulatory complexities and pricing pressures present challenges, strategic investments in emerging markets and innovation sustain positive financial trajectories.

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Key Takeaways

• Growth sustained by demographic shifts and technological advances in imaging modalities.
• Market expansion in Asia-Pacific is a major opportunity, leveraging improved healthcare infrastructure.
• Safety profile of VISIPAQUE supports continued adoption over ionic and lower-concentration alternatives.
• Competitive pressures from generics necessitate continuous innovation and differentiated positioning.
• Financial forecasts predict a CAGR of approximately 5% from 2022 to 2027, with revenues potentially reaching $335 million.

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FAQs

1. How does VISIPAQUE 270 compare to other contrast agents in terms of safety?
VISIPAQUE, as an iso-osmolar contrast agent, exhibits a lower risk of nephrotoxicity and adverse reactions compared to ionic or low-osmolar contrast agents, making it suitable for patients with renal impairment.

2. What are the key regulatory hurdles for expanding VISIPAQUE's indications?
Regulatory agencies require comprehensive safety and efficacy data, particularly for new indications or formulations. Post-market surveillance and adherence to regional standards are critical.

3. How does the emergence of generics impact the market for VISIPAQUE?
Generic competitors can exert pricing pressure, reducing margins. However, brand differentiation through safety profiles and clinical endorsement helps sustain market share.

4. Which regions are expected to drive the highest growth for VISIPAQUE?
Emerging markets such as Asia-Pacific and Latin America offer the highest growth potential due to infrastructure development and increasing healthcare expenditure.

5. What future innovations could influence VISIPAQUE's market share?
Advancements in imaging technology and the development of contrast agents with enhanced safety, efficacy, or dual imaging capabilities could impact market dynamics.

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References

1. Mordor Intelligence. (2022). Global CT Imaging Market Size, Trends & Forecasts.
2. Testa, A. C., et al. (2011). Safety comparison of iso-osmolar versus low-osmolar contrast media. Radiology, 260(1), 197-204.
3. FDA. (2004). U.S. Food and Drug Administration approval documents for VISIPAQUE 270.
4. EMA. (2022). Summary of Product Characteristics for iodixanol formulations.
5. Industry Reports. (2022). Contrast Media Market Analysis and Future Trends.

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Note: This comprehensive analysis aims to support strategic decisions related to market positioning, expansion, and R&D for stakeholders involved with VISIPAQUE 270 and similar contrast media.