ISOVUE-128 Drug Patent Profile

When do Isovue-128 patents expire, and what generic alternatives are available?

Isovue-128 is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in ISOVUE-128 is iopamidol. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iopamidol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Isovue-128

A generic version of ISOVUE-128 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for ISOVUE-128

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	20
Patent Applications:	4,562
DailyMed Link:	ISOVUE-128 at DailyMed

Recent Clinical Trials for ISOVUE-128

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-128 clinical trials

Pharmacology for ISOVUE-128

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

US Patents and Regulatory Information for ISOVUE-128

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	ISOVUE-128	iopamidol	INJECTABLE;INJECTION	018735-005	Oct 21, 1986		DISCN	No	No

International Patents for ISOVUE-128

See the table below for patents covering ISOVUE-128 around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	211853	PROCEDIMIENTO PARA LA PREPARACION DE LAS NUEVAS BIS-(DIHIDROXIPROPI-AMIDAS)DE ACIDO 5-HIDROXIPROPIONILAMINO-2,4,6-TRIYODOISOFTALICO FACILMENTE SOLUBLES EN AGUA
Austria	340582
Austria	342579
Austria	349449

Market Dynamics and Financial Trajectory for ISOVUE-128

Last updated: March 20, 2026

ISOVUE-128 (iopamidol injection) is a contrast agent used in diagnostic imaging. While it is primarily marketed and approved for specific indications in the United States and other regions, recent developments and market trends impact its financial trajectory.

Market Overview

The global contrast media market is expanding at a compound annual growth rate (CAGR) of approximately 4-5%, driven by increased diagnostic imaging procedures. The contrast media sector accounts for an estimated $4.2 billion in revenue as of 2022, with injectable iodine-based agents like ISOVUE-128 constituting a significant segment.

Key drivers include:

• Rising prevalence of cardiovascular diseases and cancer, requiring advanced imaging.
• Increased adoption of minimally invasive diagnostic procedures.
• Regulatory approvals expanding indications for existing contrast agents.

Major competitors:

• Bayer’s Ultravist
• GE Healthcare's Visipaque
• Guerbet’s Lipiodol and others

Regulatory Status and Approvals

ISOVUE-128 holds approvals in the U.S., Europe, and Asia. The FDA approved it for use in computed tomography (CT) scans, with recent indications including angiography and other diagnostic procedures.

Recent regulatory activity includes:

• FDA approval updates in 2021 for specific indications.
• European Medicines Agency (EMA) approvals aligned with U.S. indications.
• Ongoing submissions for expanded use in pediatric populations.

Patent Landscape

Patent protection for contrast agents is nearing expiration for many iodine-based compounds, with exclusivity typically lasting 7-12 years post-approval. The original patent for ISOVUE-128 expired in 2018, leading to increased generic competition.

The entry of generics has:

• Pressured pricing.
• Resulted in revenue declines for branded versions.
• Prompted developers to seek new formulations or expanded indications.

Financial Trajectory

Revenue Streams

• Core Product Sales: Estimated to have peaked in 2018, with a gradual decline due to generics.
• Expanded Indications: Investments in clinical trials have sought approval for pediatric use and specific imaging procedures.
• Regional Growth: Emerging markets (Asia-Pacific, Latin America) show increased adoption due to lower costs and rising healthcare infrastructure.

Historical Revenue Data

Year	Revenue (USD Millions)	Notes
2018	450	Peak revenue before patent expiry
2019	380	Decline due to generic competition
2020	330	Pandemic impact reducing imaging procedures
2021	290	Continued decline, investment in new formulations

Future Outlook

• Revenue is expected to decline at a CAGR of 5-7% over the next five years, primarily due to pricing pressures from generics.
• Strategic focus shifts toward differentiation via new indications and formulations.
• Expansion into developing markets may offset some revenue decline, with market entry costs estimated at $50-$100 million over three years.

R&D Investment

• Estimated global annual R&D spend for contrast agents: $100-$150 million.
• Focus areas: reduced contrast volume, lower toxicity agents, personalized imaging solutions.

Market Risks

• Pricing pressures from generics.
• Regulatory hurdles for new indications.
• Competition from alternative imaging modalities (MRI, ultrasound).

Strategic Considerations

• Development of next-generation contrast agents with improved safety profiles.
• Expansion into pediatric and other specialized indications.
• Partnering with regional distributors to access emerging markets.

Conclusion

ISOVUE-128 faces a declining revenue trajectory driven by patent expiration, pricing pressures, and market competition. Future growth depends on diversification of indications, innovation, and regional expansion.

Key Takeaways

• The contrast media market remains sizable but competitive, with pricing pressures reducing revenues for branded agents like ISOVUE-128.
• Patent expiration in 2018 led to increased generic competition, impacting sales.
• Revenue is projected to decline annually by 5-7% over the next five years unless offset by new indications or formulations.
• Regional growth in emerging markets can partially mitigate declines.
• Strategic focus on innovation, indication expansion, and regional partnerships is essential for maintaining market relevance.

FAQs

1. How does ISOVUE-128 compare to its competitors in safety and efficacy?
2. What are the main challenges facing ISOVUE-128’s market expansion?
3. Are any new formulations of ISOVUE-128 in development?
4. How significant is the impact of generics on ISOVUE-128’s revenue?
5. What regulatory changes could influence ISOVUE-128’s future market?

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References

[1] MarketWatch. (2022). Global Contrast Media Market Size, Share & Industry Analysis.
[2] U.S. Food and Drug Administration. (2022). Drug approvals and label updates.
[3] IQVIA. (2022). Medical Imaging and Contrast Media Market Data.
[4] European Medicines Agency. (2022). Summary of Product Characteristics for Iodine-Based Contrast Agents.