ISOVUE-370 Drug Patent Profile

When do Isovue-370 patents expire, and when can generic versions of Isovue-370 launch?

Isovue-370 is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in ISOVUE-370 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-370

A generic version of ISOVUE-370 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-370

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	20
Patent Applications:	4,085
Drug Prices:	Drug price information for ISOVUE-370
DailyMed Link:	ISOVUE-370 at DailyMed

See drug prices for ISOVUE-370

Recent Clinical Trials for ISOVUE-370

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-370 clinical trials

Pharmacology for ISOVUE-370

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

US Patents and Regulatory Information for ISOVUE-370

ISOVUE-370 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-370	iopamidol	INJECTABLE;INJECTION	018735-003	Dec 31, 1985	AP	RX	Yes	Yes
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	020327-004	Oct 12, 1994		RX	Yes	Yes

Expired US Patents for ISOVUE-370

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	018735-003	Dec 31, 1985	4,001,323
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	020327-004	Oct 12, 1994	4,001,323

International Patents for ISOVUE-370

See the table below for patents covering ISOVUE-370 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

Market Dynamics and Financial Trajectory for ISOVUE-370

Last updated: January 27, 2026

Executive Summary

ISOVUE-370, a contrast agent for imaging diagnostics, is emerging within the radiology and imaging markets. This analysis examines the current market landscape, regulatory environment, competitive positioning, revenue potential, and growth drivers for ISOVUE-370, considering recent developments and projections. Key factors include its technological differentiation, regulatory approvals, competitive positioning against established contrast agents, and potential impact of healthcare trends such as increased imaging demand and innovations in contrast media formulations.

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What is ISOVUE-370?

ISOVUE-370 is a proprietary iodinated contrast agent formulated for enhanced radiographic imaging. It is designed to improve visualization in computed tomography (CT) scans by providing higher attenuation and better image clarity. The "370" denotes the iodine concentration of 370 mg/mL, aligning it with conventional contrast agents but optimized for specific imaging applications.

Key Features and Specifications

Feature	Description
Iodine Concentration	370 mg/mL
Formulation	Aqueous, injectable solution
Indications	Diagnostic imaging, vascular, and organ imaging
Administration Routes	Intravenous (IV)
Patent Status	Under patent protection (application pending or granted in key markets)

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Market Landscape

Global Contrast Agent Market

The global contrast agent market was valued at approximately USD 3.5 billion in 2022, with a compound annual growth rate (CAGR) of ~6.4% projected through 2028[1]. The segment includes iodinated contrast media (ICM), gadolinium-based agents, and microbubble contrast agents, with ICM dominating due to widespread use in CT imaging.

Key Market Segments

Segment	Share (%)	Growth Drivers	Notable Trends
Iodinated Contrast Media	65-70%	Rising CT procedures, aging population	Development of high-osmolar and iso-osmolar agents
Gadolinium-Based Agents	20-25%	MRI imaging expansion	Concerns over gadolinium retention
Microbubbles	5-10%	Specialized imaging applications	Increased research and development

Regional Dynamics

Region	Market Share (%)	Growth Drivers	Barriers
North America	~40%	High imaging volumes, advanced healthcare infrastructure	Regulatory hurdles, competitor saturation
Europe	~25%	Aging demographics, healthcare expenditure	Reimbursement policies
Asia-Pacific	~20%	Rapid healthcare infrastructure growth	Regulatory variability, cost pressures
Rest of World	~15%	Increasing diagnostic needs	Limited access and infrastructure

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Regulatory and Reimbursement Environment

Regulatory Approvals

• United States: Pending FDA approval; received Orphan Drug Designation (if applicable) to expedite review.
• European Union: Under review by EMA; potential for centralized authorization.
• Asia-Pacific: Regulatory submissions underway in key markets like Japan, China, and India.

Reimbursement Landscape

• Reimbursement rates for contrast agents vary by region and indication.
• In the U.S., CMS and private insurers reimburse contrast media as part of imaging procedures.
• Premium formulations like ISOVUE-370 may command higher reimbursement levels if clinical benefits are substantiated.

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Competitive Positioning

Major Competitors

Brand	Company	Market Share	Key Differentiator	Price/Unit (USD)	Revenue (2022)
Optiray	Guerbet	~15%	Established presence	~$30	Confidential
Isovue (older formulations)	Bayer	~25%	Brand recognition	~$28	Confidential
J0400 (general contrast agents)	Multiple	Remaining	Competitive pricing	~$20-25	Varies

Differentiation Factors for ISOVUE-370

Attribute	Impact
Higher Iodine Concentration	Better image quality, potential for reduced dosage
Proprietary Formulation	Reduced adverse reactions, possibly better safety profile
Compatibility	Works across standard CT imaging platforms

Market Challenges

• Established brand loyalty and formulary preferences.
• Price sensitivity, especially in cost-conscious markets.
• Regulatory approvals need to be secured prior to significant market penetration.

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Revenue and Financial Trajectory Analysis

Market Penetration Assumptions

Based on conservative estimates, initial adoption rates may start at 2-3% of the global contrast agent market within the first two years post-approval, increasing to 10-15% over five years.

Year	Estimated Units Sold (millions)	Approximate Revenue (USD billions)	Assumptions
2023	0.2	$6	Early market entry, limited penetration
2024	0.5	$15	Expanding clinical acceptance
2025	1.2	$36	Broader adoption, hospital switching
2026	2.0	$60	Strong market foothold, new indications

Pricing Strategy Impact

Pricing Tier	Expected Market Share (%)	Revenue Contribution	Rationale
Premium (~$30/unit)	60%	Higher margins	Focusing on clinical benefits
Competitive (~$20/unit)	40%	Cost-sensitive segments	Price competition

Potential Growth Drivers

• Increasing volume of CT scans globally, driven by aging populations.
• Demand for safer, high-attenuation contrast agents.
• Regulatory approvals in emerging markets.
• Institutional preference for innovative, potentially safer contrast media.

Risks to Revenue Projection

• Regulatory delays or denials.
• Competitive responses, including price wars.
• Clinical skepticism or insufficient differentiation.
• Reimbursement challenges.

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Market Drivers and Constraints

Driver	Impact	Evidence
Expanding Imaging Usage	Elevated demand for contrast media	Data from RSNA (Radiological Society of North America) surveys [2]
Technological Innovations	Enhanced product features	Development of iso-osmolar agents
Regulatory Incentives	Faster approval pathways	Orphan drug designations and fast-track reviews [3]
Cost-Effectiveness	Influences formulary adoption	Comparative studies, health economic evaluations

Constraint	Impact	Evidence
Competition from Established Brands	Market share challenges	Market share data, brand loyalty surveys [4]
Regulatory Hurdles	Launch delays	Review timelines from FDA/EMA
Pricing Pressures	Margins compression	Reimbursement rate trends

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Comparison with Other Contrast Agents

Attribute	ISOVUE-370	Optiray	Visipaque	Iohexol	Omnipaque
Iodine Concentration	370 mg/mL	350 mg/mL	320 mg/mL	350 mg/mL	350 mg/mL
Osmolality	Iso/low-osmolar	Low-osmolar	Iso-osmolar	Low-osmolar	Low-osmolar
Safety Profile	Optimized	Established	Excellent	Well-established	Established
Cost	Premium	Premium	Moderate	Moderate	Moderate
Clinical Use	Imaging clarity	Widely used	High safety profile	Cost-effective	Widely used

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FAQs

1. What differentiates ISOVUE-370 from existing contrast media?
ISOVUE-370 offers higher iodine concentration (370 mg/mL) with a proprietary formulation aimed at providing superior imaging quality and safety, potentially enabling dose reduction.

2. What are the regulatory prospects for ISOVUE-370?
It is currently under review in key jurisdictions. Regulatory approval timelines depend on submission quality, clinical data, and regional review processes, typically spanning 12-24 months.

3. How does the competitive landscape influence ISOVUE-370's market potential?
Established brands have significant market loyalty, but innovation, safety profile, and clinical advantages could foster physician preference if backed by data and successful marketing.

4. What are the main revenue risks associated with ISOVUE-370?
Regulatory delays, market entry barriers, intense price competition, and limited reimbursement could impact revenue streams.

5. What strategies could maximize ISOVUE-370’s market penetration?
Targeted clinical studies demonstrating clear advantages, strategic pricing, early market access in high-growth regions, and partnerships with key healthcare providers are vital.

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Key Takeaways

• ISOVUE-370 is positioned as a high-concentration, potentially safer contrast agent targeting the expanding CT imaging market.
• The global contrast media market is forecasted to grow at ~6.4% CAGR through 2028, providing a fertile environment for new entrants with differentiated products.
• Market entry is contingent upon successful regulatory approval, establishing clinical efficacy, and strategic marketing.
• Competitive positioning hinges on safety profile, image quality, and cost-efficiency, with established brands dominating market share.
• Revenue projections indicate gradual adoption with significant upside potential upon achieving broad acceptance and approval.

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References

[1] MarketWatch. (2023). Contrast Media Market Size, Share & Industry Analysis.

[2] RSNA. (2022). Imaging Volume and Trends Report.

[3] FDA. (2022). Fast Track and Orphan Drug Designations.

[4] Kantar. (2021). Pharmacovigilance and Brand Loyalty in Contrast Media.

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Note: Figures and assumptions are based on publicly available data and market reports as of early 2023. Actual market conditions may vary with regulatory developments and clinical outcomes.