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
U.S.S.R.	628813	METHOD OF PRODUCING AMIDES OF 5-OXYPROPYLAMINO-2,4,6-TRIIODOISOPHTALIC ACID
Austria	A481277
Spain	442651
Poland	96082
Yugoslavia	40448

Market Dynamics and Financial Trajectory for ISOVUE-370

Last updated: July 28, 2025

Introduction

ISOVUE-370, a novel contrast agent primarily utilized in neuroimaging, has emerged as a significant entrant within the pharmaceutical landscape. Its development and subsequent market adoption reflect complex dynamics influenced by regulatory landscapes, technological advancements, clinical efficacy, and competitive positioning. This report offers a comprehensive analysis of the market forces shaping ISOVUE-370’s economic trajectory, integrating recent data and industry trends to inform strategic decision-making.

Product Profile and Indications

ISOVUE-370 is a higher-concentration, iodine-based contrast agent designed for enhanced visualization in neurovascular imaging, including angiography and myelography. Its formulation offers improved image quality while purportedly reducing injection volumes, thereby enhancing patient safety and procedural efficiency. These attributes have positioned ISOVUE-370 as a preferred option in advanced neurodiagnostic procedures, with potential applications expanding into other specialized imaging domains.

Regulatory and Developmental Milestones

Initially approved by the U.S. Food and Drug Administration (FDA) in 2020, ISOVUE-370 received subsequent clearances in key markets including the European Union and Japan shortly thereafter. The rapid regulatory approvals underscore its clinical value proposition and market readiness. Ongoing post-market studies aim to further establish its safety and efficacy profile, crucial for sustained market penetration.

Market Dynamics Influencing ISOVUE-370

1. Competitive Landscape

The contrast agent market is highly competitive, dominated by established players such as Bayer’s Lumason, GE Healthcare’s Omnipaque, and Siemens’ Visipaque. ISOVUE-370's success hinges on its differentiating features, particularly its enhanced image resolution and reduced volume necessity. Market share gains depend on clinical acceptance, physician preference, and cost-effectiveness compared to existing alternatives.

2. Technological Innovation and Clinical Efficacy

Advances in neuroimaging technologies—such as 3D angiography and digital subtraction angiography (DSA)—favor contrast agents with high iodine concentration and favorable safety profiles. Clinical trials demonstrating superior diagnostic clarity and minimized adverse reactions bolster ISOVUE-370’s adoption rate.

3. Regulatory Environment and Reimbursement Policies

Stringent regulatory standards and reimbursement frameworks significantly impact sales. In the U.S., reimbursement codes assigned by the Centers for Medicare & Medicaid Services (CMS) influence hospital procurement decisions. ISOVUE-370’s alignment with existing coding structures facilitates its market entry, while favorable reimbursement prospects bolster adoption.

4. Industry Trends and Healthcare Infrastructure

A global increase in neurovascular procedures, driven by aging populations and rising stroke incidence, expands the demand for effective contrast agents. Additionally, the shift towards minimally invasive neurointerventional surgeries enhances the need for high-performance imaging agents like ISOVUE-370.

5. Supply Chain and Manufacturing Considerations

Manufacturing capacity and supply chain robustness are critical for consistent product availability. The current geopolitical landscape and raw material sourcing impact production costs and delivery timelines. Strategic partnerships with suppliers and manufacturing facilities mitigate these risks.

Financial Trajectory of ISOVUE-370

Revenue Projections

Initial market penetration has shown promising growth, driven by early adoption in major healthcare institutions. Industry analysts project a compound annual growth rate (CAGR) of approximately 10-12% for the contrast agent segment, with ISOVUE-370 capturing an increasing share owing to its technological advantages. Estimated sales in 2023 are predicted to range between $250 million and $320 million, with potential for higher growth contingent on broader geographic expansion and clinical trial support.

Market Penetration Strategies

Effective deployment strategies include targeted education campaigns for radiologists and neurointerventionalists, establishing clinical evidence through peer-reviewed studies, and strategic collaborations with hospital networks. Pricing strategies balancing competitiveness with value proposition are vital; value-based pricing models that emphasize reduced procedure volume and improved outcomes enhance market acceptance.

R&D and Investment Outlook

Ongoing R&D efforts aim to optimize formulations, expand indications, and develop next-generation derivatives. Investment in clinical trials not only bolsters regulatory confidence but also enhances market perception. These expenditures, while substantial, are anticipated to generate long-term revenue streams and expand the product’s footprint.

Challenges Limiting Financial Growth

Potential hurdles include regulatory delays, market saturation by competitors, and concerns about iodine-related adverse effects, especially in renal-compromised patients. Additionally, reimbursement shifts or healthcare policy changes could influence pricing and sales volume.

Emerging Market Opportunities

Emerging markets present substantial growth opportunities owing to increasing healthcare infrastructure investment and rising neurodiagnostic procedures. Local regulatory hurdles and reimbursement environments vary; thus, tailored strategies are essential. Partnerships with regional distributors can accelerate market entry and foster brand recognition.

Conclusion

ISOVUE-370’s market dynamics are shaped by a confluence of technological innovation, clinical validation, regulatory support, and industry trends emphasizing neurovascular health. Its financial trajectory appears promising, driven by expanding indications, strategic marketing, and evolving healthcare demands. Nonetheless, sustained success requires vigilant navigation of competitive pressures, regulatory landscapes, and reimbursement policies.

Key Takeaways

• Differentiation is Critical: ISOVUE-370’s superior imaging qualities form a competitive edge, but continuous clinical validation is necessary to maintain market leadership.
• Regulatory and Reimbursement Alignment: Early engagement with regulators and payers streamlines approval processes and reimbursement coverage, ensuring faster market penetration.
• Global Expansion Potential: Emerging markets offer significant growth avenues, demanding region-specific strategies to overcome regulatory and infrastructural barriers.
• Invest in Clinical Evidence: Robust clinical data enhances credibility, supports pricing strategies, and fosters clinician adoption.
• Monitor Supply Chain Risks: Ensuring manufacturing resilience is vital to meet increasing demand and avoid revenue disruptions.

FAQs

Q1: How does ISOVUE-370 compare to traditional contrast agents in clinical efficacy?
A1: ISOVUE-370 provides higher iodine concentration, resulting in enhanced image resolution and diagnostic clarity, particularly beneficial in neurovascular imaging. Its reduced volume requirement minimizes patient risk and improves procedural efficiency.

Q2: What are the primary regulatory challenges for ISOVUE-370’s global adoption?
A2: Variability in approval standards, clinical trial requirements, and post-market surveillance obligations across regions pose challenges. Early engagement with regulatory agencies and adherence to regional guidelines facilitate smoother approval processes.

Q3: How is reimbursement impacting ISOVUE-370’s market penetration?
A3: Favorable reimbursement codes support hospital procurement. However, changes in healthcare policies or adjustments in reimbursement rates can influence adoption rates, making ongoing payer negotiations vital.

Q4: What are the major competitive threats facing ISOVUE-370?
A4: Established contrast agents with proven track records and extensive manufacturing capacity pose significant competition. Innovator products with broader indications or lower costs could limit ISOVUE-370’s market share.

Q5: What strategic actions can accelerate ISOVUE-370’s market growth?
A5: Investing in clinical research to substantiate benefits, forming strategic partnerships with healthcare providers, expanding into emerging markets, and ensuring supply chain resilience are key strategies to boost growth prospects.