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
M.D. Anderson Cancer Center	N/A
National Cancer Institute (NCI)	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	4,001,323

International Patents for ISOVUE-200

See the table below for patents covering ISOVUE-200 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

Market Dynamics and Financial Trajectory for ISOVUE-200 (Iosulide-200)

Last updated: July 29, 2025

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Introduction

ISOVUE-200, an injectable contrast agent containing iopamidol, has maintained a significant position within the diagnostic imaging sector since its introduction. Widely employed in angiography, computed tomography (CT), and myelography, ISOVUE-200’s market landscape has experienced notable shifts driven by technological advances, regulatory changes, and competitive dynamics. This analysis synthesizes current market conditions, regulatory trends, and financial forecasts to inform stakeholders’ strategic decisions.

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Market Overview

Product Profile and Indications

ISOVUE-200 is a non-ionic, water-soluble contrast medium primarily used for diagnostic imaging procedures that require vascular visualization. Its safety profile, rapid clearance, and high image quality have positioned it as a preferred choice in radiology suites globally. Its core indications include:

• Cerebral and vascular angiography
• CT scans for abdominal, thoracic, and pelvic imaging
• Myelography procedures

The drug’s formulation, offering a 200 mg iodine/mL concentration, balances sufficient radiopacity with minimized adverse effects, driving broad clinical adoption.

Global Market Size and Segmentation

According to market research reports, the global contrast media market was valued at approximately USD 4 billion in 2022, with expected compounded annual growth rates (CAGR) of 5-7% over the next five years [1]. Within this, iodinated contrast agents like ISOVUE-200 account for a substantial segment; their demand hinges on rising diagnostic imaging procedures, especially in emerging markets.

Regional Dynamics

• North America: Dominates due to high healthcare infrastructure, advanced radiology practices, and widespread adoption of CT and angiography. The U.S. accounts for over 60% of the global contrast media market.

• Europe: Represents a mature but steady market, with regulatory stabilities and widespread use of contrast agents.

• Asia-Pacific: Poised for rapid growth owing to increasing healthcare expenditure, urbanization, and expanding diagnostic imaging services. Countries like China and India are projected to exhibit the highest CAGR, driven partly by government initiatives to improve healthcare access.

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Market Drivers

Technological Advancements

Innovations in imaging technology have enhanced diagnostic precision, prompting increased use of iodinated contrast agents. The development of low-osmolar and iso-osmolar agents has improved safety profiles, further bolstering market demand.

Rising Incidence of Chronic Diseases

Increased prevalence of cardiovascular diseases, cancer, and neurological disorders necessitates advanced diagnostic imaging, elevating demand for contrast agents like ISOVUE-200.

Healthcare Infrastructure Expansion

The expansion of healthcare facilities, especially in emerging economies, contributes to higher utilization of contrast-enhanced imaging procedures, fostering market growth.

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Market Challenges and Regulatory Landscape

Safety Concerns and Adverse Events

Though generally safe, iodinated contrast agents may induce adverse reactions such as allergic responses, nephrotoxicity, and thyroid dysfunction. Heightened safety awareness and improved screening protocols are critical considerations influencing usage patterns.

Regulatory Approvals and Revisions

Regulatory bodies, including the FDA and EMA, periodically review contrast media safety profiles, influencing market access. Label updates and risk minimization programs impact demand.

Price and Reimbursement Dynamics

Pricing pressures from healthcare payers and insurance policies directly impact profit margins. Cost-effectiveness becomes pivotal, especially amidst increasing competition.

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Competitive Landscape

Major Players

• Bracco Imaging: Manufacturer of ISOVUE-200, with a broad global distribution network.
• GE Healthcare, Bayer, and Bracco: Compete with diverse contrast media offerings, including gadolinium and microbubble agents.

Strategic Initiatives

• Product Diversification: Development of new contrast formulations with improved safety profiles.
• Market Expansion: Focused efforts on emerging markets with tailored pricing strategies.
• Clinical Validation: Conducting studies to establish superiority or non-inferiority over competitors.

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Financial Trajectory and Forecasts

Historical Performance

While precise revenue figures globally are proprietary, ISOVUE's parent company, Bracco Imaging, has reported steady sales growth aligned with the expansion of diagnostic imaging procedures. In 2022, North American sales comprised the majority, with emerging markets contributing to incremental growth.

Projected Growth

• Short-term (2023-2025): Expected moderate growth (~3-5% CAGR), driven by increased imaging procedures and pipeline innovations.
• Medium-term (2025-2030): Accelerated growth potential (~6-8% CAGR) in Asia-Pacific due to healthcare infrastructure upgrades and expanding insurance coverage.
• Influencing Factors: Regulatory approvals for new formulations, strategic market entries, and technological integrations.

Revenue Diversification and Cost Dynamics

Revenue streams are projected to diversify, with increased contributions from new indications and formulations. Cost management strategies, including supply chain optimization amid raw material price fluctuations, will influence profit margins.

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Impact of Novel Technologies and Competition

Recent advancements in MRI and PET imaging, along with the rise of non-contrast imaging techniques, could dampen demand for iodinated contrast agents. However, their specific utility in vascular and acute imaging ensures sustained relevance for drugs like ISOVUE-200.

Competitive innovations, including microbubble-based contrast agents and gadolinium derivatives, threaten to encroach upon iodinated contrast markets, especially if safety profiles improve further.

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Strategic Outlook

• Innovation Focus: Developing next-generation contrast agents with improved safety and diagnostic accuracy.
• Market Penetration: Expanding into underserved regions through customized pricing and collaborative healthcare initiatives.
• Regulatory Engagement: Active participation in clinical trials and post-marketing surveillance to reinforce safety perceptions.

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Key Takeaways

• The global contrast media market is robust, driven by rising diagnostic procedures amid technological progress and the growing burden of chronic diseases.

• ISOVUE-200's market position benefits from its safety profile and proven efficacy, yet faces competition from novel imaging modalities and contrast agents.

• Emerging markets present significant growth opportunities, potentially doubling revenue streams over the next decade, contingent upon regulatory harmonization and healthcare infrastructure development.

• Price sensitivity and safety concerns require ongoing strategic emphasis on product innovation, clinical validation, and cost management.

• Continuous monitoring of regulatory updates, technological innovations, and competitive moves will be critical to maintaining and expanding ISOVUE-200's market share.

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FAQs

Q1: How does ISOVUE-200 compare to other contrast agents in terms of safety?

A1: ISOVUE-200, utilizing iso-osmolar, non-ionic iopamidol, has a favorable safety profile, with low incidences of allergic reactions and nephrotoxicity compared to older ionic contrast media. Its safety advantages support widespread clinical use.

Q2: What are the primary factors influencing ISOVUE-200’s market growth?

A2: Key drivers include the increasing volume of diagnostic imaging, technological advancements, healthcare infrastructure expansion—especially in Asia-Pacific—and ongoing clinical validation supporting safety and efficacy.

Q3: What competitive threats does ISOVUE-200 face?

A3: Competition from alternative contrast agents, magnetic resonance imaging (MRI) techniques with no contrast requirement, and emerging microbubble or gadolinium-based media pose potential threats, particularly if safety or cost advantages favor these alternatives.

Q4: How might regulatory changes impact ISOVUE-200?

A4: Regulatory agencies’ safety reviews, labeling updates, or restrictions on iodinated contrast agents could impact market access, usage patterns, and pricing strategies.

Q5: What strategic actions should stakeholders consider for future success?

A5: Focus on product innovation, expanding into emerging markets with tailored approaches, engaging in clinical research to validate safety and efficacy, and optimizing supply chain and pricing models are crucial.

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References

[1] Market Research Future, Contrast Media Market Research Report, 2022.