ISOVUE-250 Drug Patent Profile

When do Isovue-250 patents expire, and what generic alternatives are available?

Isovue-250 is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in ISOVUE-250 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-250

A generic version of ISOVUE-250 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-250

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-250
DailyMed Link:	ISOVUE-250 at DailyMed

See drug prices for ISOVUE-250

Recent Clinical Trials for ISOVUE-250

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

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

See all ISOVUE-250 clinical trials

Pharmacology for ISOVUE-250

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

US Patents and Regulatory Information for ISOVUE-250

ISOVUE-250 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-250	iopamidol	INJECTABLE;INJECTION	018735-007	Jul 6, 1992	AP	RX	Yes	Yes
Bracco	ISOVUE-250	iopamidol	INJECTABLE;INJECTION	020327-002	Oct 12, 1994		DISCN	Yes	No

Expired US Patents for ISOVUE-250

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-250	iopamidol	INJECTABLE;INJECTION	018735-007	Jul 6, 1992	4,001,323
Bracco	ISOVUE-250	iopamidol	INJECTABLE;INJECTION	020327-002	Oct 12, 1994	4,001,323

International Patents for ISOVUE-250

See the table below for patents covering ISOVUE-250 around the world.

Country	Patent Number	Title	Estimated Expiration
Bulgaria	26512
Yugoslavia	41540
Switzerland	608189
France	2293919

Market Dynamics and Financial Trajectory for ISOVUE-250

Last updated: July 30, 2025

Introduction

ISOVUE-250, a contrast agent primarily used in diagnostic imaging procedures, especially computed tomography (CT), has carved out a niche within the radiology and diagnostic imaging market. As a branded formulation of iodinated contrast media, ISOVUE-250 plays a vital role in enhancing the visualization of blood vessels, tissues, and organ structures, facilitating accurate diagnosis. This article explores the market dynamics shaping ISOVUE-250's commercial trajectory and analyzes its financial outlook amid evolving healthcare landscapes.

Market Landscape of Iodinated Contrast Agents

Global Diagnostic Imaging Sector

The global diagnostic imaging market steadily expands, driven by technological advancements and rising disease prevalence, particularly in oncology, cardiology, and infectious diseases. The need for enhanced imaging clarity fuels demand for contrast agents like ISOVUE-250. According to market research, the global imaging contrast media market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.6%, reaching USD 5.5 billion by 2028 (Grand View Research, 2022).

Competitive Landscape

ISOVUE-250 faces competition from both branded and generic iodinated contrast agents. Key competitors include Visipaque (iodixanol), Omnipaque (iohexol), and others. The differentiation hinges on factors such as safety profiles, viscosity, osmolality, and compatibility with specific imaging modalities. Viscosities and osmolarities influence patient tolerance, which can sway hospital and radiology center preferences.

Regulatory Environment

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have established strict guidelines on contrast media safety profiles, especially concerning adverse reactions like nephrotoxicity and allergic responses. ISOVUE-250, with an established safety record, benefits from regulatory approval status, but competition with newer, potentially safer agents continues to influence its market share.

Market Drivers for ISOVUE-250

Growing Imaging Procedures

The increasing number of imaging procedures globally, spurred by aging populations and rising chronic disease burdens, escalates demand for contrast media. For instance, the U.S. alone conducts over 50 million CT scans annually, many requiring iodinated contrast agents (CMS, 2021).

Safety Profile and Patient Tolerance

ISOVUE-250 is recognized for its relatively low incidence of adverse effects, making it suitable for use across diverse patient populations, including those with compromised renal function. Its use in specialized populations sustains its market relevance.

Technological Innovations

Advances in CT technology, such as high-definition scanning and contrast-enhanced imaging capabilities, increase the need for reliable contrast agents. ISOVUE-250's consistent performance aligns with these technological shifts, sustaining demand.

Cost-Effectiveness and Reimbursement Policies

Pricing strategies and reimbursement policies significantly influence usage. As healthcare systems worldwide aim to optimize costs, generic competition and price negotiations can impact ISOVUE-250’s market share. However, its brand recognition and proven efficacy sustain its premium positioning.

Challenges and Market Restraints

Emergence of Alternative Agents

The advent of alternative contrast agents, including gadolinium-based agents for MRI, presents competition outside traditional iodinated media. Additionally, innovation in contrast-free imaging modalities slightly diminishes reliance on contrast agents.

Safety Concerns and Adverse Reactions

Despite its safety profile, concerns about contrast-induced nephropathy (CIN) and allergic reactions prompt cautious use in high-risk populations. Newer agents claiming enhanced safety may erode ISOVUE-250’s market share.

Regulatory Challenges and Patent Expirations

Patent expirations and the rise of generics can weaken the brand’s market control. While ISOVUE-250 remains a branded product, competitors may offer more cost-effective options.

Financial Trajectory Analysis

Historical Financial Performance

While specific financial data for ISOVUE-250 is proprietary, insights can be inferred from the performance of the parent companies, notably Bracco Imaging, which markets ISOVUE-250. Historically, contrast media sales constitute a stable revenue segment owing to the consistent volume of imaging procedures worldwide (Bracco Annual Reports, 2021).

Revenue Projections

Given the steady growth in imaging diagnostics, ISOVUE-250’s revenue is expected to grow modestly at a CAGR of around 3-4% over the next five years, assuming stable market conditions. Factors such as increased outpatient imaging, expansion into emerging markets, and technological integration will influence this trajectory.

Impact of Price Competition

Price reductions resulting from generic competition could compress margins. To mitigate this, Bracco and other stakeholders may emphasize product differentiation, enhanced safety features, and expanding indications.

Market Expansion Opportunities

Emerging markets in Asia-Pacific and Latin America present favorable growth prospects due to increasing healthcare infrastructure investments. The rising penetration of CT imaging in developing economies could augment ISOVUE-250 sales volumes.

Potential Disruptions

Disruptive innovations, such as contrast-free imaging techniques—like ultrasound elastography or advanced MRI protocols—pose long-term threats to contrast agent demand. Moreover, regulatory pressures against iodinated contrast agents related to safety concerns might alter market dynamics.

Strategic Outlook

To sustain and grow its financial performance, ISOVUE-250's portfolio strategy should focus on:

• Investing in clinical research to demonstrate superior safety and efficacy profiles.
• Expanding into emerging markets, leveraging local partnerships and healthcare reforms.
• Differentiating via formulation improvements, such as lower viscosity options or reduced osmolality products.
• Developing adjunct diagnostic solutions aligned with imaging advances.

Conclusion

ISOVUE-250’s market and financial outlook remains cautiously optimistic, contingent upon the ongoing necessity for high-quality contrast media, technological advancements in diagnostic imaging, and healthcare policy developments. While facing competition and safety considerations, its reputation for safety and efficacy sustains its relevance. Strategic engagement with emerging markets and innovation will be critical to maintaining growth trajectories.

---

Key Takeaways

• The global demand for contrast media, including ISOVUE-250, is driven by increasing imaging procedure volumes worldwide.
• Competitive dynamics hinge on safety profiles, cost, and technological compatibility, with generics exerting pricing pressures.
• Market growth is expected to be modest, around 3–4% annually, influenced by technological evolution, safety concerns, and regional healthcare investments.
• Future growth opportunities lie in emerging markets and product differentiation through improved formulations.
• Long-term sustainability requires innovation, regulatory navigation, and strategic expansion into growing healthcare markets.

---

FAQs

1. How does ISOVUE-250 differentiate itself from other iodinated contrast agents?
ISOVUE-250 is recognized for its favorable safety profile, lower viscosity, and compatibility across a broad range of imaging procedures, providing clinicians with reliable imaging enhancement and minimized adverse reactions.

2. What are the main factors influencing ISOVUE-250's market share?
Market share depends on competing products, safety and efficacy profiles, pricing strategies, regulatory approvals, and adoption rates driven by technological advancements in imaging.

3. Are there safety concerns that could impact ISOVUE-250's demand?
Yes, concerns like contrast-induced nephropathy (CIN) and allergic reactions influence clinician preferences. Improvements in safety data and formulations can mitigate these concerns.

4. How viable is expanding ISOVUE-250 into emerging markets?
Highly viable, as these regions experience increasing healthcare investments and rising demand for diagnostic imaging, creating growth opportunities.

5. Will innovations in contrast-free imaging reduce demand for contrast agents like ISOVUE-250?
Potentially, as alternative imaging modalities develop. However, currently, contrast media remains an integral component of diagnostic imaging, ensuring continued relevance.

---

Sources

[1] Grand View Research, "Contrast Media Market Size, Share & Trends Analysis Report," 2022.
[2] Centers for Medicare & Medicaid Services (CMS), "Medical Imaging Utilization Data," 2021.
[3] Bracco Annual Reports, 2021.