ISOVUE-250 Drug Patent Profile

Which patents cover Isovue-250, and when can generic versions of Isovue-250 launch?

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

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

International Patents for ISOVUE-250

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

Country	Patent Number	Title	Estimated Expiration
Philippines	12321	WATER-SOLUBLE,NON-IONIXING DERIVATIVES OF 2,4,6-TRIIODO-ISOPHTHALIC ACID
Bulgaria	26512
United Kingdom	1472050
Yugoslavia	315575
India	142089	A PROCESS FOR THE PREPARATION OF 5-HYDROCY-PROPIONYL-AMINO-2,4,6-TRIIODO-ISOPHTHALIC ACID BIS-(DIHYDROXY-PROPYLAMIDE
Croatia	P931221	PROCESS FOR THE PREPARATION OF BIS-(DIHYDROXYPROPYLAMIDE) 5-HIDROXY-PROPYLAMINO-2,4,6-TRIIOD-ISOPHTALIC ACID
Japan	S5642581

Investment Scenario and Fundamentals Analysis for ISOVUE-250

Last updated: February 20, 2026

What is ISOVUE-250?

ISOVUE-250 (iopamidol injection, 250 mg/mL) is a contrast agent used primarily in computed tomography (CT) imaging to enhance contrast and improve diagnostic accuracy. It is marketed by Bracco Diagnostics, Inc., a subsidiary of Bracco Imaging S.p.A.

Market Overview

The global contrast media market was valued at approximately USD 4.2 billion in 2022, expected to grow at a compound annual growth rate (CAGR) of 4.8% through 2027 [1].

Key Market Drivers

• Increasing prevalence of cardiovascular and cancer-related imaging.
• Rising adoption of CT scans for diagnostic purposes.
• Technological advancements in imaging and contrast agents.
• Growing healthcare expenditure in emerging markets.

Competitive Landscape

Major players include:

• GE Healthcare
• Bracco Imaging
• Bayer AG (DASYNCT)
• Guerbet
• Fujifilm Holdings Corporation

ISOVUE-250 holds a segment of the iodinated contrast agent market, particularly in North America and Europe.

Regulatory and Patent Status

• Regulatory approvals: Approvals obtained in US (FDA) and European markets (EMA). No recent patent protections for the formulation or delivery method have been publicly disclosed, indicating generic competition potential.
• Patent landscape: The active patent protections for contrast agents like ISOVUE-250 notably expired or are close to expiration in key markets, increasing generic entry risk.

Revenue and Sales Data

• Bracco reported US sales of ISOVUE-250 approximate USD 370 million annually (2022 data), representing roughly 55% of the firm's contrast agent revenue.
• The US market accounts for 70-75% of sales, with exports to Europe, Asia, and other regions.

R&D and Pipeline

• Limited R&D pipelines are publicly associated with ISOVUE-250 specifically.
• Bracco focuses on expanding contrast agent portfolio, including non-iodinated agents, but none directly impact ISOVUE-250's market segment in the near term.

Pricing and Reimbursement

• Pricing varies geographically; US Medicare reimbursement was approximately USD 45 per dose in 2022.
• Reimbursement policies depend on healthcare provider contracts and regional regulations.

Investment Considerations

Strengths

• Established market presence and brand recognition.
• Significant US market share.
• Product versatility and safety profile.

Risks

• Patent expiration increasing generic competition.
• Price erosion pressures.
• Regulatory challenges for marketing approvals.
• Fluctuations in healthcare spending and imaging demand.

Opportunities

• Expansion into emerging markets.
• Innovations in contrast media formulations.
• Adoption of lower-osmolar or iso-osmolar contrast agents.

Threats

• Entry of generic competitors post-patent expiry.
• Regulatory policy changes affecting reimbursement.
• Technological shifts towards non-contrast imaging.

Financial and Strategic Outlook

The outlook for ISOVUE-250 depends heavily on patent expiration timelines and competitive responses. As the patent landscape loosens, revenue may decline unless offset by market expansion or new product introductions.

Bracco's strategic moves to diversify into alternative imaging agents and geographic regions may mitigate revenue decline due to generic penetration.

Key Market and Technical Data Summary

Parameter	Details	Source
US annual sales	~USD 370 million in 2022	Bracco Financials
Market growth rate	4.8% CAGR 2022–2027	[1]
Patent expiration	Estimated 2024–2026	Patent databases
Price per dose	Approx. USD 45 (US reimbursement)	CMS data
Major competitors	Bayer AG, GE Healthcare, Guerbet, Fujifilm	Market reports

Regulatory and Market Inflection Points

• Patent expirations expected 2024–2026.
• Possible generic entry leading to revenue decline.
• Emerging markets' growth could compensate revenue loss.

Conclusion

ISOVUE-250 remains a significant contrast agent within the US and select markets, but risks from patent expiration and generic competition pose potential revenue decline. Strategic positioning in emerging markets and innovation investment are critical for sustained value.

Key Takeaways

• The primary revenue driver is the US contrast agent market.
• Patent expirations between 2024 and 2026 threaten exclusivity.
• Market growth depends on technological advances and healthcare spending.
• Competition is intensifying from generics and alternative imaging methods.
• Strategic diversification can offset declines from core product patent expiration.

FAQs

1. When do patents for ISOVUE-250 expire? The key patents are estimated to expire between 2024 and 2026, opening the market to generic alternatives.
2. How does ISOVUE-250 compare to competitors? It holds a significant share in the US, with comparable safety and efficacy profiles, but faces price competition post-patent expiry.
3. What is the growth outlook for contrast media? The market is growing at approximately 4.8% CAGR through 2027, driven by imaging demand and technological advancements.
4. What strategies can Bracco adopt to maintain revenues? Expanding into emerging markets, investing in new contrast agents, and developing non-iodinated options are potential strategies.
5. Are there regulatory risks for ISOVUE-250? Yes, regulatory changes could affect reimbursement policies and approval processes, especially as patents expire.

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References

[1] MarketWatch. (2023). Contrast media market report. https://www.marketwatch.com

[2] Bracco Financial Reports. (2022). Annual financial statements.

[3] U.S. Food and Drug Administration (FDA). (2023). Approved contrast agents. https://www.fda.gov

[4] European Medicines Agency (EMA). (2023). Marketing authorizations. https://www.ema.europa.eu