DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE - Generic Drug Details

What are the generic drug sources for diatrizoate meglumine; iodipamide meglumine and what is the scope of patent protection?

Diatrizoate meglumine; iodipamide meglumine is the generic ingredient in one branded drug marketed by Bracco and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE at DailyMed

US Patents and Regulatory Information for DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	SINOGRAFIN	diatrizoate meglumine; iodipamide meglumine	SOLUTION;INTRAUTERINE	011324-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Market Dynamics and Financial Trajectory for Diatrizoate Meglumine and Iodipamide Meglumine

Last updated: August 3, 2025

Introduction

The pharmaceutical landscape for diagnostic contrast agents, notably diatrizoate meglumine and iodipamide meglumine, is characterized by evolving market dynamics driven by technological advancements, regulatory shifts, and expanding healthcare needs. Both compounds are iodinated radiopaque agents used primarily in imaging procedures such as X-rays, fluoroscopy, and angiography. Their market performance hinges on factors including clinical efficacy, safety profiles, regulatory approvals, and competition from emerging contrast media. This analysis explores current market trajectories and forecasted financial potential for these drugs within the diagnostic imaging sector.

Market Overview and Key Driver Factors

Global Demand for Contrast Agents

The global demand for contrast media is projected to grow at a compounded annual growth rate (CAGR) of approximately 5.2% between 2023 and 2030, driven by increasing prevalence of chronic diseases, rising adoption of minimally invasive imaging procedures, and technological improvements in radiology equipment [1]. Contrast agents such as diatrizoate meglumine and iodipamide meglumine, classified as ionic and nonionic iodinated compounds respectively, constitute a significant segment within this market.

Reimbursement and Adoption Trends

Healthcare reimbursement policies heavily influence market dynamics. Favorable reimbursement frameworks in developed regions—particularly North America and Europe—have bolstered utilization rates of contrast media. Conversely, cost-control measures and stringent safety regulations have prompted manufacturers to innovate and improve safety, affecting product adoption and pricing strategies.

Technological Innovations and Competition

The proliferation of nonionic, low-osmolar contrast agents (LOCAs) has intensified competition, impacting the market share of traditional ionic compounds like diatrizoate meglumine. Meanwhile, efforts to develop safer, more efficient agents continue, causing a gradual shift in prescription patterns. The emergence of gadolinium-based agents and carbon dioxide as alternative contrast media also influences demand dynamics.

Regulatory Environment

Regulatory agencies such as the FDA and EMA strictly oversee safety and efficacy standards. Recent concerns regarding contrast-induced nephropathy (CIN) and allergic reactions have prompted tighter regulations and post-market surveillance. Companies investing in safety profiling and compliant manufacturing processes position themselves favorably, influencing market growth and product valuation.

Market Dynamics for Diatrizoate Meglumine

Product Positioning and Market Share

Diatrizoate meglumine, an ionic high-osmolar contrast agent, historically dominated the market due to extensive clinical use. However, its market share has declined with the advent of LOCAs, attributed to safety concerns and adverse effect profiles like fluid shifts and osmotic load-related complications [2].

Financial Trajectory and Outlook

Despite reduced growth, diatrizoate meglumine maintains niche applications, especially in developing regions where cost considerations favor older, inexpensive contrast agents. Manufacturers' revenues are expected to stabilize or decline marginally, but with potential pockets of demand in emergent markets where regulatory barriers are less stringent.

Pricing and Revenue Considerations

Pricing pressures are intensifying, driven by competitive offerings and increased scrutiny on healthcare expenditure. Diatrizoate meglumine's low cost offers some resilience, yet profit margins are compressed. Strategic markets include India, China, and Latin America, where healthcare infrastructure expansion sustains volume sales.

Market Dynamics for Iodipamide Meglumine

Therapeutic and Market Position

Iodipamide meglumine, a nonionic, low-osmolar contrast agent, benefits from an improved safety profile and broader application in coronary angiography and CT imaging [3]. However, it faces stiff competition from newer agents with enhanced imaging qualities and fewer adverse reactions.

Financial Prospects and Challenges

Market growth for iodipamide meglumine is modest. The shift toward nonionic agents limits its expansion, although it remains relevant in settings prioritizing established, cost-effective contrast media. Revenues are projected to plateau, with some decline anticipated as newer agents surpass it technically and commercially.

Pricing Strategy and Market Penetration

Compared to diatrizoate meglumine, iodipamide meglumine commands a premium due to safety advantages. Nonetheless, market penetration is constrained by the availability of alternative compounds and the conservative preferences of some healthcare providers. Key growth opportunities are mainly in regions with less access to cutting-edge technology.

Emerging Trends and Future Market Trajectory

The future of contrast media, including diatrizoate meglumine and iodipamide meglumine, will be shaped by:

• Innovative Agents: Development of iso-osmolar, nonionic, and more biocompatible contrast media.
• Personalized Medicine: Tailoring contrast media based on patient-specific risk profiles.
• Regulatory Stringency: Enhancing safety standards and post-market surveillance.
• Digital Healthcare: Integration with AI-driven imaging techniques to optimize contrast media efficacy.
• Environmental Concerns: Addressing biosafety and disposal issues impacting manufacturing and usage.

The compounded effect of these factors suggests a moderate decline in traditional ionic contrast agents’ market share, with sustained, albeit niche, revenues from established compounds like diatrizoate meglumine and iodipamide meglumine, especially in cost-sensitive markets.

Financial Outlook and Investment Considerations

While innovation continues to diminish reliance on ionic agents like diatrizoate meglumine, opportunistic markets retain significance for manufacturers with cost-effective, compliant legacy products. The value proposition revolves around balancing safety, efficacy, and cost, with emerging markets looking for affordable contrast solutions amidst healthcare expansion.

In the near term, companies holding patents, or with strategic partnerships to commercialize compatible formulations, will maximize revenue streams. Long-term, a pivot toward safer, nonionic contrast media may constrain the profitability of traditional agents, necessitating diversification and R&D investments.

Key Takeaways

• Market Shift to Safer Agents: Safety concerns have shifted preference toward low-osmolar, nonionic contrast agents, reducing the market share of ionic products like diatrizoate meglumine and iodipamide meglumine.
• Regional Variations: Developing markets continue to favor legacy agents due to cost advantage, providing stable revenue streams, while developed regions favor newer, safer technologies.
• Pricing and Cost-Effectiveness: Despite safety advantages, premium pricing for nonionic agents constrains growth, making cost-effective ionic agents relevant in budget-conscious settings.
• Regulatory and Safety Trends: Increasing safety regulations and awareness will influence product formulations, manufacturing standards, and market entry strategies.
• Innovative Therapeutics and Imaging Technologies: Advances in imaging modalities and contrast media formulations could redefine market compositions, pressuring traditional compounds.

Conclusion

The financial trajectory of diatrizoate meglumine and iodipamide meglumine is characterized by a gradual shift from widespread use to niche applications. Their continued relevance depends on regional economic factors, regulatory landscapes, and technological innovations. Market players optimizing safety profiles, cost-efficiency, and compliance will sustain profitability, while adaptation to emerging technologies will be critical for long-term competitiveness.

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FAQs

1. What factors most influence the decline of ionic contrast agents like diatrizoate meglumine?
   Safety concerns, regulatory restrictions, and technological advancements favor nonionic, low-osmolar agents, reducing ionic contrast media's market share.

2. In which regions do diatrizoate meglumine and iodipamide meglumine retain significant market presence?
   Primarily in developing countries due to their affordability and existing infrastructure, despite the global trend toward newer agents.

3. How do safety profiles impact the financial outlook of contrast media?
   Better safety profiles enhance market acceptance, justify premium pricing, and reduce liability risks, thereby positively influencing revenues.

4. Are there emerging competitors threatening established contrast agents?
   Yes, non-traditional agents like gadolinium-based compounds and CO₂ are gaining traction in specific imaging applications.

5. What strategic moves can pharmaceutical companies make to optimize revenues from these contrast agents?
   Focusing on cost-effective manufacturing, expanding into emerging markets, ensuring compliance with safety standards, and investing in R&D to develop safer formulations.

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Sources

[1] Market Research Future, "Contrast Media Market," 2022.
[2] FDA Medical Devices Safety Communications, "Contrast Media and Kidney Risks," 2019.
[3] European Society of Radiology, "Contrast Media Safety," 2021.