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Last Updated: July 17, 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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Drug patent expirations by year for DIATRIZOATE MEGLUMINE
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Medical Subject Heading (MeSH) Categories for DIATRIZOATE MEGLUMINE

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 ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Anda Repository DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM diatrizoate meglumine; diatrizoate sodium SOLUTION;ORAL, RECTAL 214201-001 Jun 27, 2022 AA RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Annora Pharma DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM diatrizoate meglumine; diatrizoate sodium SOLUTION;ORAL, RECTAL 215049-001 Nov 17, 2023 AA RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Diatrizoate Meglumine

Last updated: July 5, 2025

Introduction

Diatrizoate meglumine, a key iodinated contrast agent used in medical imaging, plays a vital role in diagnostics for procedures like X-rays, CT scans, and gastrointestinal examinations. As healthcare demands rise globally, this pharmaceutical compound faces evolving market pressures and financial shifts. This analysis examines the current market dynamics and financial trajectory of diatrizoate meglumine, offering insights for business professionals navigating the pharmaceutical sector. With increasing competition from advanced alternatives and regulatory hurdles, understanding these trends is essential for informed investment and strategic decisions.

Overview of Diatrizoate Meglumine

Diatrizoate meglumine functions as a radiopaque medium, enhancing visibility in imaging studies by absorbing X-rays. First introduced in the mid-20th century, it remains a staple in clinical settings for detecting abnormalities in the urinary tract, gastrointestinal system, and beyond. Manufacturers produce it in various formulations, often combined with diatrizoate sodium, under brand names like Gastrografin.

The drug's market relevance stems from its established efficacy and cost-effectiveness, particularly in emerging economies where advanced imaging agents are less accessible. However, its chemical properties—such as potential for allergic reactions and osmotic effects—drive ongoing innovation in safer alternatives. Global production centers in regions like North America and Europe ensure steady supply, but supply chain disruptions, as seen during the COVID-19 pandemic, have exposed vulnerabilities.

Current Market Dynamics

The market for diatrizoate meglumine is influenced by rising diagnostic imaging volumes, driven by an aging population and increasing chronic disease prevalence. According to a 2023 report by MarketsandMarkets, the global contrast media market, which includes diatrizoate meglumine, reached approximately $5.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6.5% through 2028. This expansion reflects heightened demand in oncology, cardiology, and neurology diagnostics.

Competition intensifies from non-ionic agents like iohexol and iopamidol, which offer lower toxicity and better patient tolerance. Major players, including Bracco Diagnostics and GE Healthcare, dominate with innovative portfolios, eroding diatrizoate meglumine's market share. In the U.S., generic versions from companies like Sandoz and Fresenius Kabi have commoditized the product, leading to price erosion. For instance, wholesale prices for diatrizoate meglumine formulations dropped by about 15% between 2020 and 2023, as reported in IQVIA data.

Regulatory factors further shape dynamics. The FDA and EMA enforce strict guidelines on contrast agents, emphasizing safety and environmental impact. Recent updates, such as the 2022 FDA advisory on iodinated contrast shortages, have prompted manufacturers to bolster production capacity. In Europe, the REACH regulations add compliance burdens, potentially increasing costs for producers. Meanwhile, in Asia-Pacific markets like China and India, demand surges due to expanding healthcare infrastructure, with local firms gaining ground through cost-competitive manufacturing.

Economic pressures, including inflation and currency fluctuations, affect distribution. Hospitals and imaging centers prioritize cost over brand loyalty, favoring generics and bulk purchases. This trend underscores a shift toward value-based procurement, where diatrizoate meglumine's affordability maintains its relevance despite technological advancements.

Financial Performance and Trajectory

Financially, diatrizoate meglumine's trajectory reflects a mature product lifecycle. Patents expired decades ago, transforming it into a generic staple with limited revenue growth potential. Data from Statista indicates that global sales of iodinated contrast agents, including diatrizoate meglumine, generated around $2.8 billion in 2022, with the compound contributing a modest portion due to its generic status.

Key manufacturers report steady, but not explosive, revenues. For example, Bracco Group's 2022 annual report highlighted contrast media as a core revenue driver, though specific figures for diatrizoate meglumine were not disclosed. Analysts estimate that generic producers achieve margins of 20-30% on this drug, constrained by low pricing and high manufacturing costs. In contrast, innovative players invest in R&D for next-generation agents, diverting resources from older products like diatrizoate meglumine.

Looking ahead, financial projections hinge on market consolidation and strategic partnerships. A 2023 analysis by Grand View Research forecasts that while the overall contrast media market will expand, diatrizoate meglumine's segment may grow at a slower 4% CAGR through 2030. This deceleration stems from substitution risks, as healthcare providers adopt safer options amid rising litigation over adverse events.

Currency risks and geopolitical tensions, such as U.S.-China trade disputes, impact import-dependent markets. For instance, European exporters face challenges from Brexit-related tariffs, compressing profits. On a positive note, emerging markets in Latin America and Africa present opportunities, with increased healthcare spending potentially boosting demand by 10-15% annually, as per World Health Organization estimates.

Investors should note that while diatrizoate meglumine offers stable cash flows for generic firms, its financial upside is limited without differentiation strategies, such as eco-friendly formulations or combination therapies.

Challenges and Opportunities

Diatrizoate meglumine confronts several challenges, including safety concerns and environmental scrutiny. Reports of hypersensitivity reactions, as documented in a 2021 study published in the Journal of Allergy and Clinical Immunology, have led to cautious prescribing practices. Additionally, the drug's iodine content raises ecological issues, with wastewater disposal regulations tightening in regions like the EU.

Yet, opportunities abound. The growing telemedicine and point-of-care imaging sectors could sustain demand, particularly in remote areas. Partnerships with AI-driven diagnostic tools might enhance its utility, creating new revenue streams. For instance, integrating diatrizoate meglumine with machine learning algorithms for automated image analysis could differentiate it in a crowded market.

Sustainability initiatives offer another avenue. Companies focusing on biodegradable contrast agents could revitalize interest, potentially increasing market share through green certifications. In summary, while challenges persist, proactive innovation positions diatrizoate meglumine for resilience in a dynamic pharmaceutical landscape.

Future Outlook

The future of diatrizoate meglumine hinges on adaptation to technological and regulatory shifts. By 2030, experts predict a bifurcated market: high-income regions favoring advanced agents, while low- and middle-income areas rely on cost-effective options like diatrizoate meglumine. This duality could stabilize its financial trajectory, with annual revenues holding steady at $500-700 million globally.

Advancements in nanotechnology and personalized medicine may reduce reliance on traditional contrast agents, but diatrizoate meglumine's proven track record ensures its place as a backup option. Strategic acquisitions, such as Bayer's 2022 purchase of a contrast media portfolio, signal ongoing consolidation that could influence pricing and availability.

Business professionals should monitor global health trends, including post-pandemic recovery and aging demographics, to gauge long-term prospects. Overall, while growth moderates, diatrizoate meglumine remains a reliable component of the pharmaceutical ecosystem.

Key Takeaways

  • Diatrizoate meglumine's market dynamics are shaped by increasing diagnostic demands and competition from safer alternatives, leading to price pressures in mature markets.
  • Financial performance shows stability for generic producers, with projected modest growth driven by emerging economies.
  • Regulatory and safety challenges pose risks, but opportunities in sustainable innovations and partnerships could sustain its trajectory.
  • Investors should prioritize cost management and market diversification to navigate potential revenue declines.
  • The drug's role in global healthcare underscores its enduring value, despite a shift toward advanced imaging solutions.

FAQs

  1. What factors are driving demand for diatrizoate meglumine? Demand primarily stems from the rising volume of diagnostic imaging procedures worldwide, particularly in regions with limited access to advanced contrast agents, though safety concerns may temper growth.
  2. How has patent expiration affected its financial trajectory? With patents expired, diatrizoate meglumine has become a generic product, resulting in lower prices and reduced profit margins for manufacturers, but it maintains steady revenues through high-volume sales.
  3. What competition does diatrizoate meglumine face in the market? It competes with non-ionic contrast agents like iohexol, which offer better safety profiles, potentially eroding its market share in developed markets while retaining dominance in cost-sensitive areas.
  4. How do regulatory changes impact its production? Stricter FDA and EMA regulations on safety and environmental standards increase compliance costs, potentially raising production expenses and affecting profitability for manufacturers.
  5. What future trends could influence its market position? Trends such as AI integration in imaging and a focus on sustainable pharmaceuticals could either challenge or enhance diatrizoate meglumine's role, depending on how manufacturers adapt their strategies.

Sources

  1. MarketsandMarkets. "Contrast Media Market Size, Share & Trends Analysis Report by Product (Iodinated, Gadolinium), by Application (Radiology, Interventional Radiology), by Region, and Segment Forecasts, 2023-2030."
  2. Grand View Research. "Contrast Media/Contrast Agent Market Size, Share & Trends Analysis Report by Product (Iodinated Contrast Media), by Application (Interventional Cardiology), by End-use, by Region, and Segment Forecasts, 2023-2030."
  3. IQVIA Institute. "The Global Use of Medicines 2023 Outlook."

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