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Last Updated: March 27, 2026

Diatrizoate meglumine; diatrizoate sodium - Generic Drug Details


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

Diatrizoate meglumine; diatrizoate sodium is the generic ingredient in eighteen branded drugs marketed by Bayer Hlthcare, Intl Medication, Ge Healthcare, Mallinckrodt, Liebel-flarsheim, Bracco, Anda Repository, and Annora Pharma, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for diatrizoate meglumine; diatrizoate sodium
US Patents:0
Tradenames:18
Applicants:8
NDAs:15
Finished Product Suppliers / Packagers: 4
DailyMed Link:diatrizoate meglumine; diatrizoate sodium at DailyMed
Pharmacology for diatrizoate meglumine; diatrizoate sodium

US Patents and Regulatory Information for diatrizoate meglumine; diatrizoate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt MD-60 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 087074-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare GASTROVIST diatrizoate meglumine; diatrizoate sodium SOLUTION;ORAL, RECTAL 087728-001 Sep 23, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Anda Repository DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM diatrizoate meglumine; diatrizoate sodium SOLUTION;ORAL, RECTAL 214201-001 Jun 27, 2022 AA RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Liebel-flarsheim MD-GASTROVIEW diatrizoate meglumine; diatrizoate sodium SOLUTION;ORAL, RECTAL 087388-001 Approved Prior to Jan 1, 1982 AA RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco RENOVIST diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 010040-020 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ge Healthcare HYPAQUE-76 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 086505-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco RENOGRAFIN-76 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 010040-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 and Diatrizoate Sodium

Last updated: February 15, 2026

Overview

Diatrizoate meglumine and diatrizoate sodium are ionic radiocontrast agents used primarily in radiographic imaging procedures such as angiography, myelography, and urography. These compounds facilitate visualization of internal structures by enhancing the contrast in imaging. Their market faces shifts driven by technological advancements, regulatory changes, and competitive landscape adjustments.

Market Size and Growth

The global radiocontrast agent market was valued at approximately USD 2.8 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 5.2% from 2023 to 2030, reaching roughly USD 4.1 billion by 2030 [1].

Within this market, iodinated contrast agents—specifically monomers like diatrizoate compounds—dominate with an estimated 35–40% market share. Their usage remains prevalent in nations with established imaging infrastructure.

Market Drivers

  • Aging Population: An increase in age-related conditions requiring diagnostic imaging, including cardiovascular and neurological disorders, sustains demand.

  • Technological Advances: Improvements in imaging procedures drive the need for enhanced contrast agents. Although non-ionic agents increase patient safety, ionic agents like diatrizoate compounds still see use in specific cases.

  • Healthcare Infrastructure Expansion: Emerging economies investing in medical imaging equipment contribute to regional market growth.

Market Restraints

  • Safety Profile and Side Effects: Ionic contrast agents have higher incidences of adverse reactions such as nephrotoxicity and allergic responses compared to non-ionic alternatives, which restricts their use [2].

  • Regulatory Actions: Stringent safety standards in the US, EU, and Japan limit their applications, especially in vulnerable populations.

  • Emerging Alternatives: Gadolinium-based agents for MRI and non-contrast imaging techniques replace traditional iodinated agents in certain indications.

Competitive Landscape

Major players include Guerbet, Bayer, GE Healthcare, and Bracco Imaging. Bayer's iopamidol and GE's iohexol are often preferred over diatrizoate agents due to better safety profiles.

Market share for diatrizoate-based products has decreased over the past decade. Still, they retain a niche, especially in resource-limited settings and specific procedural applications.

Pricing and Revenue Forecasts

  • Pricing Dynamics: Prices for diatrizoate meglumine and sodium products are influenced by generic competition, regulatory compliance costs, and regional purchasing power.

  • Revenue Trends: Bayer's diatrizoate meglumine-based products historically generated USD 150–200 million annually globally. These figures are projected to decline at a CAGR of 2–3% due to reduced usage, with some regions maintaining steady sales due to supply chain constraints.

Regulatory and Policy Outlook

  • Stricter labeling requirements and contraindication updates are becoming commonplace. For example, the FDA issued warnings in 2021 about the nephrotoxic potential of ionic contrast agents, leading to cautious prescribing practices [3].

  • Many countries demand post-market surveillance data, impacting the cost structure and time-to-market for new formulations.

Research and Development Trends

  • Efforts focus on reducing toxicity, improving stability, and expanding indications.

  • Some companies explore hybrid agents that combine ionic and non-ionic components or incorporate new imaging modalities.

Implications for Investors and R&D

  • Market share shifts toward non-ionic agents threaten the long-term viability of diatrizoate products.

  • Companies maintaining a portfolio of iodinated contrast agents need to innovate or diversify into MRI or other imaging areas.

  • Manufacturing and approval costs for reformulated or new contrast agents are rising, impacting margins.

Key Takeaways

  • The global radiocontrast agent market grows modestly but is increasingly dominated by biomolecular and technological advancements.

  • Diatrizoate meglumine and diatrizoate sodium sustain niche applications due to safety concerns and regulatory constraints.

  • The declining trend in sales suggests strategic repositioning, including R&D into safer, more efficient contrast agents.

  • Competitive advantage hinges on innovation and compliance with evolving safety standards.

  • Regional disparities persist; developing economies may continue to rely on older iodinated agents owing to cost and infrastructure factors.

Frequently Asked Questions

  1. What factors most significantly impact the demand for diatrizoate contrast agents?
    Safety concerns, regulatory policies, technological alternatives, and regional healthcare infrastructure influence demand.

  2. How do safety profiles compare between ionic and non-ionic contrast agents?
    Ionic agents like diatrizoate have higher incidences of adverse reactions, which limits their use in favor of safer, non-ionic alternatives.

  3. What is the future outlook for diatrizoate-based contrast agents?
    Usage is expected to decline gradually as new agents with better safety and imaging efficiency emerge, but they will remain in specific niches.

  4. Are there ongoing innovations for ionic contrast agents?
    Yes, research explores formulations reducing toxicity and enhancing imaging features, potentially prolonging their relevance.

  5. How do regional markets differ in the adoption of diatrizoate compounds?
    Developed countries favor non-ionic agents; in contrast, resource-limited regions continue to rely on older ionic agents due to cost and availability.

Citations

[1] MarketsandMarkets. Radiocontrast Agent Market, 2022-2030.
[2] US Food and Drug Administration. Safety Announcement on Ionic Contrast Agents, 2021.
[3] European Medicines Agency. Review of Iodinated Contrast Media, 2020.

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