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Last Updated: March 26, 2026

Ioxaglate meglumine; ioxaglate sodium - Generic Drug Details


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What are the generic sources for ioxaglate meglumine; ioxaglate sodium and what is the scope of freedom to operate?

Ioxaglate meglumine; ioxaglate sodium is the generic ingredient in one branded drug marketed by Guerbet and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for ioxaglate meglumine; ioxaglate sodium
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
DailyMed Link:ioxaglate meglumine; ioxaglate sodium at DailyMed

US Patents and Regulatory Information for ioxaglate meglumine; ioxaglate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Guerbet HEXABRIX ioxaglate meglumine; ioxaglate sodium INJECTABLE;INJECTION 018905-002 Jul 26, 1985 DISCN No 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

Expired US Patents for ioxaglate meglumine; ioxaglate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Guerbet HEXABRIX ioxaglate meglumine; ioxaglate sodium INJECTABLE;INJECTION 018905-002 Jul 26, 1985 4,014,986 ⤷  Start Trial
Guerbet HEXABRIX ioxaglate meglumine; ioxaglate sodium INJECTABLE;INJECTION 018905-002 Jul 26, 1985 4,065,553 ⤷  Start Trial
Guerbet HEXABRIX ioxaglate meglumine; ioxaglate sodium INJECTABLE;INJECTION 018905-002 Jul 26, 1985 4,094,966 ⤷  Start Trial
Guerbet HEXABRIX ioxaglate meglumine; ioxaglate sodium INJECTABLE;INJECTION 018905-002 Jul 26, 1985 4,065,554 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Ioxaglate meglumine; ioxaglate sodium Market Analysis and Financial Projection

Last updated: February 16, 2026

What Are the Market Dynamics for Ioxaglate Meglumine and Ioxaglate Sodium?

The global market for contrast agents, including ioxaglate meglumine and ioxaglate sodium, is driven by the increasing use of diagnostic imaging procedures—primarily computed tomography (CT) scans. These agents are classified as iodinated contrast media and are used to enhance imaging clarity.

The contrast agent segment represents approximately 35-40% of the overall diagnostic imaging market, valued at around $4 billion in 2022, with expected growth at a compound annual growth rate (CAGR) of 4–6% over the next five years. The growth factors include rising prevalence of chronic diseases requiring imaging, advancements in imaging technology, and an increased preference for minimally invasive diagnostics.

Key Market Drivers:

  • Rising Incidence of Cardiovascular and Oncological Diseases: Drive demand for contrast-enhanced CT scans.
  • Technological Advancements: Development of low-osmolar and iso-osmolar contrast agents reduces adverse effects and expands use.
  • Regulatory Approvals: Faster approval of contrast agents for specific indications bolsters market growth.

Market Challenges:

  • Safety Concerns: Risk of allergic reactions, nephrotoxicity, and other adverse effects limit widespread adoption.
  • Regulatory Restrictions: Increased oversight for iodinated contrast media affects product approvals and market access.
  • Competition: Presence of multiple established contrast agents limits market share for newer entrants or less widely used products.

Regional Analysis:

North America holds the dominant share (~45%) due to high imaging procedure rates and technological adoption. Europe accounts for about 25-30%, with Asia-Pacific showing rapid growth attributed to expanding healthcare infrastructure and increasing diagnostics utilization.

What Is the Current Financial Trajectory for Ioxaglate Meglumine and Ioxaglate Sodium?

Both compounds are iodinated contrast agents, but their market presence varies. Ioxaglate meglumine and sodium are available under brands like Hexabrix (Mallinckrodt) and others, though usage has declined in some regions due to safety concerns and market competition from newer agents.

Revenue Trends:

  • The contrast media market peaked around $4 billion in 2022, with a CAGR estimated at 4–6%, driven by global imaging demand.
  • Specific sales figures of ioxaglate compounds are not publicly disclosed but are estimated to comprise less than 10% of global iodinated contrast media sales, given the dominance of agents like iohexol and iodixanol.
  • In 2020, sales declined marginally due to COVID-19 disrupting elective procedures, but a rebound occurred post-2021.

Pricing Dynamics:

  • The average price per dose for iodinated contrast agents ranges from $30 to $70, depending on region and formulation.
  • Availability of generic versions and biosimilars could increase price competition.

Market Outlook:

The trajectory for ioxaglate meglumine and sodium is downward relative to newer agents. The decline results from safety profile improvements favoring non-ionic, iso-osmolar agents (e.g., iodixanol), which have reduced adverse reaction rates. As a result, global market share for ioxaglate compounds is expected to decrease by 5–10% annually over the next five years.

Are There Regulatory Factors Affecting the Market and Financial Outlook?

Yes. Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) impose safety standards that influence the use of iodinated contrast media.

Regulatory Developments:

  • Post-2018 alerts regarding gadolinium-based agents prompted increased scrutiny on iodinated agents, emphasizing safety and adverse event monitoring.
  • Reimbursement policies in North America favor newer, safer contrast agents; reimbursement for older agents like ioxaglate has become more limited or non-existent.
  • Some countries have banned or restricted the use of high-osmolar agents, favoring low-osmolar alternatives.

Impact on Market and Financials:

  • Newly approved contrast agents gain market share, diminishing returns for older agents.
  • Manufacturers of ioxaglate products face pressure to update formulations or repurpose existing products.
  • Regulatory delays or restrictions can lead to decreased revenue streams and increased R&D costs.

How Do Competitive Dynamics Influence Market and Revenue Forecasts?

The contrast media market is highly competitive with the presence of key players like GE Healthcare, Bracco Imaging, and Bayer AG. These companies develop and market advanced contrast agents with better safety profiles, limiting market penetration for older agents such as ioxaglate.

Competitive Factors:

  • Product Differentiation: New agents provide improved safety profiles and imaging capabilities.
  • Pricing Strategies: Competitive pricing and biosimilars influence profit margins.
  • Market Penetration Strategies: Expanding regional presence and obtaining regulatory approvals in emerging markets.

As a result, market share for ioxaglate meglumine and sodium is diminishing. The demand for these agents will likely decline at a rate consistent with their safety and efficacy profiles relative to newer contrast media.

What Are the Key Takeaways?

  • The global contrast media market is valued at approximately $4 billion (2022), expanding at 4–6% CAGR.
  • Iodinated contrast agents like ioxaglate meglumine and sodium account for a modest share, with declining sales driven by safety concerns and more advanced alternatives.
  • North America leads regional adoption, but regulatory restrictions are impacting sales.
  • The financial trajectory points toward decreasing revenue, with significant pressure from newer, safer contrast agents.
  • Industry competition and regulatory environments are accelerating the decline of older iodinated contrast media.

Frequently Asked Questions

  1. What factors are accelerating the decline of ioxaglate meglumine and sodium? Safety concerns, regulatory restrictions, and the availability of newer agents with improved safety profiles diminish demand.

  2. How does safety profile influence market share in contrast agents? Agents with fewer adverse reactions gain favor, leading to increased adoption and market share over older agents.

  3. Are there emerging markets for iodine contrast media? Yes, Asia-Pacific and Latin America are experiencing growth in diagnostic imaging utilization, but market shifts favor newer agents.

  4. What role do patent expirations play? Patent expirations can lead to generic competition, reducing prices and margins for branded agents like ioxaglate.

  5. What is the outlook for existing contracts and supply agreements? Many legacy contracts are being renegotiated or phased out, requesting migration to newer contrast agents with better efficacy and safety.


References

[1] MarketWatch, "Contrast Media Market Size, Trends & Forecast," 2022.
[2] Transparency Market Research, "Contrast Media Market," 2023.
[3] FDA Safety Alerts, 2018.
[4] GlobalData Healthcare, "Imaging Agents Market," 2023.
[5] European Medicines Agency, "Regulation of Contrast Agents," 2022.

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