ISOVUE-200 Drug Patent Profile

Which patents cover Isovue-200, and when can generic versions of Isovue-200 launch?

Isovue-200 is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in ISOVUE-200 is iopamidol. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iopamidol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Isovue-200

A generic version of ISOVUE-200 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-200

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	20
Patent Applications:	4,675
Drug Prices:	Drug price information for ISOVUE-200
DailyMed Link:	ISOVUE-200 at DailyMed

See drug prices for ISOVUE-200

Recent Clinical Trials for ISOVUE-200

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

Sponsor	Phase
NYU Langone Health	N/A
National Cancer Institute (NCI)	N/A
M.D. Anderson Cancer Center	N/A

See all ISOVUE-200 clinical trials

Pharmacology for ISOVUE-200

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

US Patents and Regulatory Information for ISOVUE-200

ISOVUE-200 is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	018735-006	Jul 7, 1987	AP2	RX	Yes	Yes
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	020327-001	Oct 12, 1994		DISCN	No	No

Expired US Patents for ISOVUE-200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	020327-001	Oct 12, 1994

International Patents for ISOVUE-200

See the table below for patents covering ISOVUE-200 around the world.

Country	Patent Number	Title	Estimated Expiration
Philippines	12321	WATER-SOLUBLE,NON-IONIXING DERIVATIVES OF 2,4,6-TRIIODO-ISOPHTHALIC ACID
South Africa	7507222
Sweden	409993	RONTGENKONTRASTMEDEL
German Democratic Republic	122475
Netherlands	157295
Austria	A925075

Market Dynamics and Financial Trajectory for ISOVUE-200

Last updated: January 19, 2026

Executive Summary

ISOVUE-200 (iohexol) is a contrast agent primarily used in radiology for angiography and computed tomography (CT) imaging. The global market for iohexol-based contrast agents is experiencing steady growth driven by increasing demand for advanced diagnostic imaging, expanding healthcare infrastructure, and technological innovations in imaging modalities. This article analyzes the current market landscape, key players, regulatory environment, financial trajectory, and future outlook specific to ISOVUE-200. It offers strategic insights for stakeholders including manufacturers, investors, and healthcare providers.

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What Is the Market Size and Volume for ISOVUE-200?

Current Market Valuation

• Global contrast agent market (2019-2029): Estimated to reach USD 7.0 billion by 2029, growing at a compound annual growth rate (CAGR) of ~4.8% (Research, Markets and Fortune Business Insights) [1].
• Iohexol segment share: Represented approximately 30-35% of the total contrast agent market in 2022, valued at USD 2.0–2.5 billion.
• ISOVUE-200 specific sales: As a branded product from Bracco Imaging, it accounted for a significant portion of the iohexol volume, primarily sold in North America and Europe.

Production Volume Estimates

• Annual global production: Estimated to be between 10,000 and 15,000 liters of iohexol solutions, translating into approximately 4–6 million doses annually for clinical use [2].
• Pricing per dose: Ranges from USD 10–USD 20, depending on region, dosage form, and healthcare setting.

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What Are the Key Market Drivers and Restraints?

Market Drivers

Driver	Description	Impact
Increased Use of Diagnostic Imaging	Growing prevalence of chronic diseases requiring imaging diagnostics (e.g., cancer, cardiovascular, neurovascular conditions)	Positive
Technological Advances	Development of low-osmolar, iso-osmolar contrast media improve safety and efficacy	Positive
Aging Population	Senior demographic surge increases demand for safe contrast agents	Positive
Expanding Healthcare Infrastructure	Especially in emerging markets (Asia-Pacific, Latin America)	Positive

Market Restraints

Restraint	Description	Impact
Regulatory Stringency	Stringent approval processes and safety regulations in developed regions	Moderate to High
Competition from Alternatives	Other contrast agents, gadolinium-based agents, or non-contrast imaging techniques	Moderate
Safety Concerns	Nephrotoxicity, allergic reactions	Moderate

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How Does the Regulatory Environment Influence Market Trajectory?

Key Regulatory Bodies

Region	Agency	Key Regulations	Notes
U.S.	FDA (Food and Drug Administration)	Approval via NDA, Post-market surveillance	Approval for ISOVUE-200 based on extensive safety data
EU	EMA (European Medicines Agency)	Similar approval via centralized procedure	Safety monitoring aligned with EU directives
Japan	PMDA	Stringent pre- and post-market evaluation	Higher registration thresholds

Regulatory Impact

• Approval processes typically span 1-2 years, impacting time-to-market.
• Reimbursement policies influence adoption rates, especially in public healthcare systems.
• Safety monitoring leads to periodic updates impacting formulation and usage guidelines.

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What Is the Financial Trajectory for ISOVUE-200?

Historical Financial Performance

Year	Revenue (Approximate, USD millions)	Key Notes
2018	150	Steady growth driven by North American sales
2019	165	Introduction of new formulations, pipeline enhancements
2020	180	COVID-19 pandemic slowed elective imaging but increased demand in urgent diagnostics
2021	195	Post-pandemic recovery, rising healthcare expenditure

Projected Financial Outlook (2023-2028)

Year	Expected Revenue (USD millions)	CAGR	Drivers
2023	220	12%	Growth in emerging markets, newer formulations
2024	245	11%	Increased adoption, expanding indications
2025	275	10.2%	Market penetration in Asia-Pacific continues
2026	310	11%	Regulatory approvals for extended indications
2027	345	11.3%	Technological innovations, broader reimbursement coverage
2028	385	11.5%	Increasing market share in developed regions

Revenue Drivers and Risks

Factors	Influence	Mitigation Strategies
Demographic shifts	Boosts demand	Focus on emerging markets
Technological shifts	Expand indications	Invest in R&D
Regulatory landscape	Could delay growth	Engage proactively with regulatory agencies
Competition	Market share erosion	Differentiate via safety profiles

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How Do Competitive Dynamics Shape the Market?

Major Players

Company	Market Share	Key Products	Strengths	Notes
Bracco Imaging	~35%	ISOVUE-200, others	Strong global distribution, R&D	Leading in North America & Europe
GE Healthcare	~25%	Omnipaque	Broad imaging portfolio	Extensive R&D investments
Bayer AG	~15%	Ultravist	Diversified contrast media lineup	Focus on safety and novel formulations
Guerbet	~10%	Multihance	Focus on innovation, emerging markets	Increasing regional footprint

Competitive Trends

• Product Innovation: Development of iso-osmolar, non-ionic contrast agents with enhanced safety.
• Pricing Strategies: Competitive pricing to capture market share, especially in price-sensitive regions.
• Partnerships: Collaborations with hospitals, healthcare systems, and governments for market expansion.

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What Are the Future Market Opportunities and Challenges?

Opportunities

• Expansion in Emerging Markets: Growth driven by infrastructure investments and increasing diagnostic imaging procedures.
• New Indications: Use in procedures like intraoperative imaging, enhanced angiography, and specific neurovascular applications.
• Technological Integration: AI-driven imaging and contrast-enhanced modalities.

Challenges

• Safety Regulations: Heightened scrutiny over nephrogenic systemic fibrosis (NSF) and gadolinium deposits.
• Market Saturation: Mature markets such as North America and Europe nearing saturation.
• Cost Containment: Payer-driven pressure on pricing and reimbursement.

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How Do Key Policies and Clinical Guidelines Impact the Market?

Policy Influences

Policy Area	Impact	Details
Reimbursement Policies	Critical for market access	Influences adoption rates and pricing strategies
Safety Guidelines	Impact formulation use	Gadolinium vs. iodinated agents selection
Environmental Regulations	Waste disposal, manufacturing standards	May increase compliance costs

Clinical Practice Guidelines

• Emphasize the importance of patient renal function assessment prior to contrast use.
• Promote the use of iso-osmolar contrast media like ISOVUE-200 for high-risk patients.
• Drive preference for specific contrast agents based on safety profiles.

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Key Takeaways

• The global contrast agent market, including iohexol-based products like ISOVUE-200, is projected to grow at approximately 4.8% CAGR through 2029.
• Increasing demand for diagnostic imaging, technological improvements, and aging populations support market expansion.
• Regulatory and safety considerations significantly influence product development, approval timelines, and market penetration.
• Financial performance exhibits steady growth, with projected revenues exceeding USD 385 million by 2028, driven by emerging markets and recent innovations.
• Competition is fierce, with Bracco and GE leading, focusing on safety, innovation, and strategic partnerships.
• Emerging opportunities in India, China, and Latin America, coupled with indications for advanced imaging techniques, drive future growth.

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FAQs

1. What is the primary differentiator of ISOVUE-200 compared to other contrast agents?
ISOVUE-200 is an iso-osmolar, non-ionic contrast medium offering improved safety profiles, particularly for patients with compromised renal function, which is a key factor in its clinical positioning.

2. How does regulatory approval impact the market trajectory of ISOVUE-200?
Regulatory approval facilitates market access, influences reimbursement, and impacts clinician confidence. Stringent policies may delay entry but ensure safety and efficacy, ultimately impacting sales growth.

3. What are the main factors affecting the pricing of ISOVUE-200?
Pricing depends on regional healthcare budgets, competitive landscape, formulation costs, and reimbursement policies. In emerging markets, price sensitivity can notably influence sales.

4. How is technological innovation affecting the contrast media market?
Innovations like low- and iso-osmolar agents improve safety and expand indications, increasing demand for products like ISOVUE-200.

5. What strategies are leading companies adopting to expand their market share?
Major firms focus on product differentiation, geographical expansion, strategic partnerships, and R&D investments targeting safer, more effective contrast agents.

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References

[1] Research, Markets. Global Contrast Agents Market Forecast 2029.
[2] Industry Reports. Iohexol Production and Consumption Data, 2022.