ISOVUE-300 Drug Patent Profile

Which patents cover Isovue-300, and what generic alternatives are available?

Isovue-300 is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in ISOVUE-300 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-300

A generic version of ISOVUE-300 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-300

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
DailyMed Link:	ISOVUE-300 at DailyMed

Recent Clinical Trials for ISOVUE-300

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-300 clinical trials

Pharmacology for ISOVUE-300

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

US Patents and Regulatory Information for ISOVUE-300

ISOVUE-300 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-300	iopamidol	INJECTABLE;INJECTION	018735-002	Dec 31, 1985	AP	RX	Yes	Yes
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	020327-003	Oct 12, 1994		RX	Yes	Yes

Expired US Patents for ISOVUE-300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	018735-002	Dec 31, 1985
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	020327-003	Oct 12, 1994

International Patents for ISOVUE-300

See the table below for patents covering ISOVUE-300 around the world.

Country	Patent Number	Title	Estimated Expiration
U.S.S.R.	628813	METHOD OF PRODUCING AMIDES OF 5-OXYPROPYLAMINO-2,4,6-TRIIODOISOPHTALIC ACID
Austria	A481277
Spain	442651
Poland	96082

Market Dynamics and Financial Trajectory for ISOVUE-300

Last updated: July 30, 2025

Introduction

ISOVUE-300 (iopamidol) is a non-ionic, water-soluble iodinated contrast agent primarily used in X-ray imaging procedures, such as computed tomography (CT) scans. Since its advent, ISOVUE-300 has become integral to diagnostic radiology, driven by its efficacy, safety profile, and versatility. This analysis evaluates current market dynamics and forecasts the financial trajectory of ISOVUE-300 amid evolving healthcare landscapes, technological advancements, and regulatory considerations.

Market Overview and Current Position

The global iodinated contrast media market, where ISOVUE-300 operates, was valued at approximately USD 2.6 billion in 2022, with a compound annual growth rate (CAGR) projected around 4-5% through 2030 [1]. This growth is fueled by increasing prevalence of chronic diseases, improved diagnostic imaging protocols, and expanding access to advanced healthcare in emerging markets.

As a non-ionic contrast agent, ISOVUE-300 benefits from superior safety, reduced adverse reactions, and enhanced image resolution compared to older ionic formulations. These attributes sustain its demand across diagnostic centers and hospitals, especially in developed economies with high procedural volumes.

Market Drivers Influencing ISOVUE-300's Trajectory

1. Rising Diagnostic Imaging Demand

Global increases in cardiovascular, oncological, and neurological investigations elevate demand for high-quality contrast agents. CT imaging, an area where ISOVUE-300 is extensively utilized, is experiencing rapid uptake due to its non-invasive approach and detailed imaging capabilities. The expanding clinical applications directly correlate with increased contrast agent procurement.

2. Advancements in Imaging Technologies

Progress in imaging modalities, including multidetector CT and dual-energy CT, demand high-contrast media with exceptional safety profiles [2]. ISOVUE-300's non-ionic formulation benefits from this trend, ensuring its role in advanced diagnostic workflows.

3. Regulatory Environment and Safety Profile

Regulatory agencies, such as the U.S. Food and Drug Administration (FDA), scrutinize contrast agents for safety concerns like nephrotoxicity and allergic reactions. ISOVUE-300's favorable safety profile has favored continued market approval, although regulatory hurdles in certain regions may influence market penetration.

4. Healthcare Expenditure and Accessibility

Increased healthcare spending, especially in emerging markets, improves access to diagnostic imaging. Government initiatives, medical tourism, and private healthcare expansion propel contrast media sales. However, price sensitivity and reimbursement policies significantly impact procurement decisions.

5. Competition from Emerging Alternatives

While ISOVUE-300 remains a preferred agent, emerging contrast agents with lower costs or tailored properties, such as blood pool or molecularly targeted agents, pose competitive threats [3].

Market Challenges

1. Competition and Patent Landscape

While ISOVUE-300 benefits from established presence, patent expirations and biosimilar entries could reduce pricing power and global market share in the coming years.

2. Concerns Over Nephrotoxicity

Despite its safety, contrast-induced nephropathy remains a concern, especially in vulnerable populations. Regulatory advisories and clinical practices focus on risk mitigation, possibly affecting usage rates.

3. Environmental Impact and Waste Management

Disposal and environmental effects of iodinated contrast media are under scrutiny, leading to stricter regulations that may increase operating costs and influence procurement preferences.

Financial Trajectory and Forecasts

Historical Performance

As a mature product, ISOVUE-300's revenues have exhibited steady growth, aligned with the broader contrast media market. In 2022, mid-single-digit revenue growth was observed, supported by increased imaging procedures globally and parent company strategies to expand distribution.

Future Outlook

Forecasts suggest that ISOVUE-300 will maintain a CAGR of approximately 3-4% from 2023 to 2030, driven by the continual rise in diagnostic imaging and incremental market expansion. Factors that could amplify growth include:

• Expanding emerging markets: Rapid healthcare infrastructure development in Asia-Pacific and Latin America offers new sales avenues.
• Technological integrations: Compatibility with cutting-edge imaging systems enhances clinical appeal.
• Strategic alliances: Collaborations with hospitals and radiology providers could solidify market penetration.

Conversely, pricing pressures, the introduction of biosimilar contrast agents, and regulatory complexity could temper growth prospects.

Revenue and Profitability Prospects

Given global market trends, ISOVUE-300's revenue remains relatively stable, with profitability margins supported by established manufacturing processes and brand recognition. As patent protections diminish or expire, manufacturers may adopt value-based strategies, including volume sales or bundled service offerings, to sustain financial performance.

Regulatory and Market Expansion Strategies

To capitalize on emerging opportunities, stakeholders should focus on:

• Regulatory compliance: Navigating regional approval processes to expand market access.
• Education campaigns: Highlighting safety benefits over competing agents.
• Cost optimization: Reducing manufacturing costs through process innovations.
• Market diversification: Targeting non-traditional diagnostic applications and underpenetrated geographic regions.

Conclusion

ISOVUE-300 stands at the intersection of established safety, technological compatibility, and expanding global imaging needs. Its market dynamics are favorable, with consistent growth projections anchored by increasing diagnostic procedures and technological innovations. Nonetheless, competitive pressures, regulatory landscapes, and environmental concerns necessitate strategic agility to sustain its financial trajectory.

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Key Takeaways

• Steady Market Growth: The global contrast media market is projected to grow at 4-5% CAGR, underpinning ISOVUE-300's continued demand.
• Technological Alignment: Compatibility with advanced imaging modalities sustains its clinical relevance.
• Emerging Markets: Rapid healthcare infrastructure expansion in emerging economies presents significant growth opportunities.
• Regulatory and Safety Factors: Ongoing safety assessments and regulatory compliance are critical to market stability.
• Competitive Landscape: Biosimilars and alternative agents pose future challenges; strategic differentiation remains vital.

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FAQs

1. What makes ISOVUE-300 a preferred contrast agent for diagnostic imaging?
Its non-ionic, water-soluble formulation offers superior safety, reduced allergic reactions, and high image quality, making it preferred in diverse radiology settings.

2. How will patent expirations impact ISOVUE-300’s market?
Patent expirations could lead to increased competition from generic or biosimilar alternatives, potentially lowering prices and market share unless differentiated by safety, performance, or cost-efficiency.

3. What regions present the most promising growth prospects for ISOVUE-300?
Emerging markets in Asia-Pacific, Latin America, and Africa, driven by healthcare expansion and increasing procedural volumes, are poised for substantial growth.

4. Are there significant regulatory challenges facing ISOVUE-300?
Yes. Regulatory bodies emphasize safety, particularly nephrotoxicity and allergic reactions. Compliance with regional standards and environmental regulations also influences market access.

5. How might technological innovation influence ISOVUE-300’s future?
Advancements in dual-energy CT and molecular imaging could demand even higher-quality contrast media, encouraging formulation improvements or targeted contrast agents, potentially affecting ISOVUE-300’s competitive position.

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References

[1] Market Research Future. "Contrast Media Market Size, Share & Industry Analysis." 2022.
[2] Radiological Society of North America. "Advances in Imaging Technologies." 2021.
[3] Pharmacovigilance journal. "Emerging Contrast Agent Technologies and Market Competition." 2022.