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Last Updated: December 12, 2025

DIATRIZOATE MEGLUMINE Drug Patent Profile


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Which patents cover Diatrizoate Meglumine, and what generic alternatives are available?

Diatrizoate Meglumine is a drug marketed by Bracco, Anda Repository, and Annora Pharma. and is included in three NDAs.

The generic ingredient in DIATRIZOATE MEGLUMINE is diatrizoate meglumine; diatrizoate sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.

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US Patents and Regulatory Information for DIATRIZOATE MEGLUMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco DIATRIZOATE MEGLUMINE diatrizoate meglumine INJECTABLE;INJECTION 010040-017 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Anda Repository DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM diatrizoate meglumine; diatrizoate sodium SOLUTION;ORAL, RECTAL 214201-001 Jun 27, 2022 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Annora Pharma DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM diatrizoate meglumine; diatrizoate sodium SOLUTION;ORAL, RECTAL 215049-001 Nov 17, 2023 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: Diatrizoate Meglumine

Introduction
Diatrizoate Meglumine, a radiopaque contrast agent primarily used in diagnostic imaging procedures, has established its presence within the medical imaging sector over decades. Its role in enhancing visualization of internal structures during radiography, fluoroscopy, and angiography positions it as an essential component in the diagnostic toolkit. This report examines the current market dynamics and financial prospects surrounding Diatrizoate Meglumine, scrutinizing factors influencing demand, competitive landscape, pricing strategies, regulatory environment, and future growth trajectories.

Market Overview

The global market for contrast agents, including Diatrizoate Meglumine, is experiencing steady growth driven by rising prevalence of chronic diseases requiring diagnostic imaging, technological advancements in medical imaging, and expanding healthcare infrastructure. According to [Market Research Future], the contrast media market is projected to reach USD 4.5 billion by 2028, with radiopaque contrast agents constituting a significant share. Diatrizoate Meglumine, as an ionic, water-soluble contrast agent, remains pivotal for emergency and outpatient diagnostics, especially in developed nations with robust healthcare systems.

Demand Drivers

Growing Diagnostic Imaging Procedures: An increasing volume of imaging procedures such as CT scans and angiographies directly amplifies demand for contrast agents. The American College of Radiology reports a rise in contrast-enhanced studies, propelling the need for radiopaque agents like Diatrizoate Meglumine.

Prevalence of Chronic and Acute Conditions: Chronic cardiovascular, neurological, and oncological conditions necessitate detailed imaging, spurring the use of iodinated contrast media. The global burden of cardiovascular diseases alone, expected to reach USD 1.1 trillion by 2030, correlates with heightened demand for competitively effective contrast agents.

Regulatory Approvals and Product Accessibility: Regulatory approval timelines and the availability of Diatrizoate Meglumine in key markets like North America, Europe, and parts of Asia bolster market stability. Manufacturers' compliance with FDA and EMA standards assures market access, maintaining steady demand.

Technological Advancements: Innovations enhancing the safety profile and image quality of contrast media, including lower osmolality formulations, have expanded clinical applications. Although Diatrizoate Meglumine is an older, high-osmolar agent, ongoing usage hinges on its cost-effectiveness and availability in emergent markets.

Market Challenges and Regulatory Landscape

Safety Concerns and Side Effects: Allergic reactions, nephrotoxicity, and contrast-induced nephropathy pose risks, prompting a shift towards low-osmolar and iso-osmolar agents. Regulatory agencies have imposed stricter safety regulations, necessitating manufacturers to incorporate risk mitigation strategies for Diatrizoate Meglumine.

Competitive Landscape: The market faces intense competition from low-osmolar and iso-osmolar contrast agents, such as Iopamidol and Iodixanol, which offer improved safety profiles. This competitive pressure suppresses pricing power for older agents like Diatrizoate Meglumine.

Supply Chain and Cost Considerations: Fluctuations in raw material prices, manufacturing costs, and distribution logistics influence profit margins. Market participants must optimize these elements amidst regulatory compliance costs.

Pricing and Revenue Trajectory

Despite its longstanding presence, Diatrizoate Meglumine's revenue trajectory is moderated by market preferences shifting towards safer alternatives. Nonetheless, in emerging markets and resource-constrained settings, it remains a cost-effective option, supporting consistent sales volumes.

Pricing strategies are influenced by factors such as formulation complexity, regulatory environment, and the presence of generics. In developed regions, premium pricing is limited due to the availability of safer alternatives, leading to a plateau or slight decline in pricing. Conversely, in developing markets where cost considerations prevail, Diatrizoate Meglumine maintains competitive pricing, fostering stable revenues.

Projection models estimate a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, driven by ongoing diagnostic needs and emerging market penetration. Growth is expected to be tempered by safety concerns and increasing adoption of newer agents.

Market Players and Competitive Strategies

Prominent manufacturers, including Bayer and Guerbet, dominate the market with mature product portfolios. Their strategies encompass expanding regional distribution, enhancing safety features, and pursuing regulatory approvals for new formulations. Generic manufacturers are also leveraging cost advantages, intensifying price competition.

Emerging players focus on developing novel contrast agents with improved safety, potentially disrupting incumbents. Companies investing in research and development (R&D) aim to address safety concerns associated with Diatrizoate Meglumine, positioning themselves optimally for future growth.

Regulatory Environment and Impact

Global regulatory authorities, notably the FDA, EMA, and MHLW, impose rigorous testing and safety standards. Post-marketing surveillance data influence ongoing market access; reports of adverse effects have prompted warnings and usage restrictions that impact sales. Nonetheless, adherence to regulations sustains market stability. Future regulatory trends favor low- or iso-osmolar agents, potentially constraining Diatrizoate Meglumine's market share.

Future Growth Trajectory

While the overall contrast media market is projected to expand modestly, the share attributable to Diatrizoate Meglumine may decline gradually due to safety concerns and clinician preferences. However, in specific regions—particularly Asia-Pacific, Latin America, and Africa—its cost-effectiveness sustains demand.

Technological innovation and regulatory compliance could open niche markets for improved formulations of Diatrizoate Meglumine with reduced adverse effects, extending its relevance. Moreover, growth in emergent markets and outpatient diagnostics offers a steady revenue stream.

Key Factors Influencing Market Trajectory

  • Adoption trends favoring low- or iso-osmolar contrast media.
  • Regulatory policies emphasizing patient safety.
  • Cost considerations and healthcare infrastructure development in emerging markets.
  • Innovations reducing adverse effects and expanding clinical utility.

Key Takeaways

  • Steady Demand in Emerging Markets: Cost-effective Diatrizoate Meglumine remains vital where healthcare budgets are constrained, ensuring consistent revenue streams.
  • Gradual Market Displacement: Safer, low-osmolar agents are gradually replacing Diatrizoate Meglumine in developed markets, capping growth.
  • Regulatory Scrutiny and Safety as Market Drivers: Stringent safety standards influence product development and market accessibility, impacting financial prospects.
  • Competitive Intensity and Pricing Pressures: Market players must innovate and optimize supply chains to maintain profitability amid intense competition from generics and newer agents.
  • Long-term Outlook: While revenues may plateau or decline in mature regions, emerging markets and technological improvements may sustain some growth potential.

Conclusion

Diatrizoate Meglumine remains a significant contrast agent within the global diagnostic imaging landscape, particularly in regions where cost considerations take precedence. Market dynamics are characterized by a gradual shift towards safer, more advanced contrast media; however, the availability, affordability, and existing clinical reliance ensure its ongoing relevance. Companies operating within this space must balance safety improvements, regulatory compliance, and cost strategies to optimize their financial trajectory amid evolving market preferences.

FAQs

  1. What are the primary clinical uses of Diatrizoate Meglumine?
    Diatrizoate Meglumine is used as a radiopaque contrast agent in diagnostic imaging procedures such as X-rays, fluoroscopy, and angiography to improve visualization of internal structures.

  2. How does the safety profile of Diatrizoate Meglumine compare to newer contrast agents?
    Older agents like Diatrizoate Meglumine are associated with higher osmolality, increasing risks of allergic reactions and contrast-induced nephropathy. Newer low- and iso-osmolar agents offer enhanced safety but at higher costs.

  3. What factors are likely to influence the future demand for Diatrizoate Meglumine?
    Demand will be driven by healthcare infrastructure development in emerging markets, cost considerations, safety concerns, and clinician preferences for newer agents.

  4. Are regulatory restrictions impacting the global market for Diatrizoate Meglumine?
    Yes. Stricter safety regulations and adverse event reports have led to usage restrictions in some regions, impacting sales and encouraging shifts to newer contrast agents.

  5. What strategies can manufacturers employ to extend the product life cycle of Diatrizoate Meglumine?
    Investing in formulation improvements to reduce adverse effects, expanding into emerging markets, and offering competitive pricing are key strategies to sustain market relevance.

Sources

[1] Market Research Future. "Contrast Media Market Forecast to 2028," 2021.

[2] American College of Radiology. "ACR Data on Imaging Procedures," 2022.

[3] Transparency Market Research. "Contrast Media Market Analysis," 2022.

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