Last Updated: May 3, 2026

ipodate sodium - Profile


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What are the generic drug sources for ipodate sodium and what is the scope of freedom to operate?

Ipodate sodium is the generic ingredient in two branded drugs marketed by Bayer Hlthcare and Bracco, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ipodate sodium
US Patents:0
Tradenames:2
Applicants:2
NDAs:2

US Patents and Regulatory Information for ipodate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare BILIVIST ipodate sodium CAPSULE;ORAL 087768-001 Aug 11, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco ORAGRAFIN SODIUM ipodate sodium CAPSULE;ORAL 012967-001 Approved Prior to Jan 1, 1982 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

Ipodate sodium Market Analysis and Financial Projection

Last updated: February 11, 2026

What Is the Investment Outlook for Ipodate Sodium?

Ipodate sodium, an iodine-containing radiocontrast agent primarily used in diagnostic imaging, presents limited direct investment opportunities due to its specialized medical use. The compound's market depends heavily on radiology procedures and healthcare infrastructure, which are growing modestly. Market projections suggest slow growth driven mainly by increased diagnostic imaging procedures globally, especially in emerging markets. Competitive dynamics show limited innovation since the drug’s patent has expired, resulting in widespread generic availability.

What Are the Key Market Drivers and Constraints?

Market Drivers:

  • Global increase in diagnostic imaging procedures. The number of computed tomography (CT) scans, where ipodate sodium is used, is rising at approximately 4-6% annually worldwide[1].
  • Growing healthcare expenditure, especially in emerging economies, boosts access to imaging diagnostics.
  • Aging populations increase demand for diagnostic services, including contrast agents.

Market Constraints:

  • Patent expiration: The original patent expired in late 1990s, leading to additional generic formulations reducing market prices.
  • Competition: Several generics from multiple manufacturers further suppress prices and profit margins.
  • Regulatory challenges: Stringent approval processes and safety concerns about iodine-based contrast agents (e.g., allergic reactions, nephrotoxicity) limit new formulations and indication expansion.
  • Limited scope for innovation: The drug’s utility hinges on diagnostic procedures; no therapeutic benefit leads to little incentive for R&D investment.

What Are the Fundamentals of the Supply and Demand for Ipodate Sodium?

Supply predominantly comes from generic manufacturers with established manufacturing facilities. The drug's production isn't complex, but regulatory compliance influences market entry and exit.

Demand is steady but constrained. It depends directly on the volume of radiological procedures, which grow moderately. The drug’s use has remained relatively stable over recent years, with no significant new indications or formulations emerging.

How Do Patent and Regulatory Status Impact the Investment Landscape?

The patent expiry of ipodate sodium led to commoditization, resulting in a fragmented market where multiple players sell identical or near-identical products. No recent regulatory approvals for new indications mean minimal innovation-driven growth.

Regulatory bodies like the FDA and EMA enforce strict safety standards, requiring post-market safety surveillance. Patent expirations can lead to price erosion, highlighting limited revenue prospects for branded formulations.

What Are the Competitive Dynamics?

Major generic manufacturers, including that of Bayer AG and other regional players, sell ipodate sodium at low margins. Market competition keeps prices near cost, reducing profitability. Market share is dispersed, with no dominant players holding significant patent protections or exclusive rights.

Financial Performance and Investment Viability

Given the mature, commoditized nature of ipodate sodium, investment returns depend on volume sales rather than price premiums. Margins are narrow, and growth is tied to the overall radiology procedure volume.

The pipeline for new applications or reformulations is virtually nonexistent, limiting upside. Periodic regulatory reviews can challenge continued market access but have historically maintained safety standards without restricting market viability.

Future Outlook and Strategic Considerations

For investors, ipodate sodium presents low-growth, stable-market characteristics primarily suited for institutions targeting healthcare equipment and reagents portfolios. It holds limited appeal for speculative investment or pharmaceutical innovation funds.

In contrast, companies seeking diversification into imaging agent generics may maintain interest despite marginal returns. Strategic considerations include geographic expansion into emerging markets, where diagnostic growth may boost volumes.

Key Takeaways

  • Ipodate sodium's market growth depends on global imaging procedure trends, with no recent innovation or indication expansion.
  • Patent expiry resulted in commoditized, low-margin sales dominated by generic manufacturers.
  • Market dynamics are constrained by safety concerns, regulatory requirements, and competition, limiting profit potential.
  • Investment prospects are limited to stable revenues driven primarily by procedure volume increases, with minimal upside potential.
  • Strategic positioning should focus on volume expansion in emerging markets rather than innovation or patent protection.

FAQs

1. Is there potential for new formulations or indications for ipodate sodium?

No significant development pipeline exists for new formulations or indications. Its utility remains confined to diagnostic imaging procedures.

2. How does patent expiration affect the market for ipodate sodium?

Patent expiration in the late 1990s led to generic proliferation, generating price competition and reducing profit margins for branded manufacturers.

3. What regulatory issues could influence future sales of ipodate sodium?

Regulatory bodies enforce safety standards concerning iodine-based contrast agents. Safety concerns and adverse event reports can lead to usage restrictions, affecting sales.

4. Can emerging markets offer growth opportunities for ipodate sodium?

Yes, rising healthcare infrastructure and diagnostic imaging volume can increase demand, but margins remain low due to prevalent generics.

5. How does the health trends landscape influence the market for contrast agents like ipodate sodium?

Growth in imaging procedures influences demand; however, technological advances and new contrast agents may shift preferences, impacting older agents like ipodate sodium.


References

[1] SIAP, "Global imaging procedure statistics," 2022.

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