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Last Updated: December 19, 2025

IPODATE CALCIUM - Generic Drug Details


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

Ipodate calcium is the generic ingredient in one branded drug marketed by Bracco and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for IPODATE CALCIUM
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 8
Patent Applications: 398
DailyMed Link:IPODATE CALCIUM at DailyMed

US Patents and Regulatory Information for IPODATE CALCIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco ORAGRAFIN CALCIUM ipodate calcium GRANULE;ORAL 012968-001 Approved Prior to Jan 1, 1982 DISCN 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

Market Dynamics and Financial Trajectory for Ipodate Calcium

Last updated: July 28, 2025

Introduction

Ipodate calcium, a contrast agent used primarily for diagnostic imaging, has historically held a niche position within the pharmaceutical and healthcare markets. With its specific indications for angiography and computed tomography (CT), the drug's market performance and financial prospects are closely tied to advancements in imaging technology, regulatory environments, and shifting clinical practices. This in-depth analysis delineates the current market landscape, dynamics influencing growth, and the forecasted financial trajectory for Ipodate calcium.

Market Overview and Historical Context

Ipodate calcium is a non-ionic, iodinated contrast agent synthesized for radiographic studies. Its primary application involves providing contrast enhancement during angiographic procedures and enhancing CT imaging clarity. Initially approved in the 1980s, Ipodate calcium enjoyed limited but stable usage. However, over the past two decades, the contrast agent market has evolved—dominated by newer, safer, and more versatile agents, leading to a gradual decline in Ipodate's market share [1].

Current Market Dynamics

1. Competitive Landscape and Technological Evolution

The contrast media sector has undergone significant transformation with the advent of low-osmolar ionic and non-ionic contrast agents. These newer formulations boast improved safety profiles, lower adverse event rates, and enhanced imaging quality. As a result, Ipodate calcium faces stiff competition from drugs such as iohexol, iodixanol, and other modern contrast agents [2].

While some niche applications may still depend on Ipodate calcium, its penetration into the broader imaging market diminishes. The pharmaceutical market has favored agents with reduced risks of nephrotoxicity and allergic reactions, further constricting Ipodate calcium’s market viability.

2. Regulatory and Patent Landscape

Although Ipodate calcium is off-patent in many regions, regulatory status varies globally. In some markets, regulatory agencies may have restricted or limited approval due to concerns over safety profile or supersession by newer agents. Any future regulatory changes or safety concerns could impact demand. Additionally, patent expirations—if any—have facilitated generic competition, further pressure on pricing and margins.

3. Clinical Practice Trends

Clinical preferences increasingly favor contrast agents with broader safety margins and ease of administration. For instance, non-ionic, low-osmolar agents have become standards in many institutions. This trend constrains the application scope for Ipodate calcium, relegating it potentially to specialized or legacy uses.

4. Pricing and Reimbursement Environment

In markets with strict reimbursement policies, cost-effectiveness heavily influences product choice. As newer agents become more competitively priced, Ipodate calcium faces declining reimbursement prospects, squeezing profit margins for manufacturers and limiting market expansion opportunities.

Future Market Drivers and Restraints

1. Technological Innovation Favoring Newer Agents

Advances in imaging, such as dual-energy CT and enhanced MRI, are reducing reliance on traditional iodinated contrast agents like Ipodate calcium. These innovations favor agents with higher safety profiles and adaptability, further diminishing Ipodate calcium's role.

2. Growing Prevalence of Chronic Diseases

The rising incidence of cardiovascular and oncological diseases, requiring extensive imaging, could create opportunities for contrast agents with favorable safety profiles. However, unless Ipodate calcium can demonstrate superior safety or cost advantages, its market share remains limited.

3. Regulatory Focus on Safety and Environmental Concerns

Regulatory agencies are increasingly emphasizing environmental impact and safety profiles. contrast agents linked to nephrotoxicity or environmental hazards could face bans or restrictions, adversely affecting Ipodate calcium's market trajectory.

Financial Trajectory and Market Outlook

1. Revenue Trends

Given the competitive pressure and declining usage, revenue from Ipodate calcium is expected to contract over the next five years. Industry analysts project a compound annual decline rate (CAGR) of approximately 8–12%, reflecting reduced utilization, pricing pressures, and generic competition [3].

2. Market Segments and Geographic Variability

The product retains minimal relevance in developed markets where newer contrast agents dominate. Conversely, in emerging markets with limited adoption of advanced agents, Ipodate calcium may sustain marginal sales, although these are unlikely to significantly alter global financial trajectories.

3. Strategic Opportunities

Opportunities for Ipodate calcium revenues exist primarily through niche applications, such as specialized procedures or legacy system requirements. Nonetheless, growth prospects remain subdued absent innovative repositioning or significant regulatory support.

Implications for Stakeholders

  • Pharmaceutical Companies: Should evaluate diversification strategies, possibly phasing out Ipodate calcium in favor of higher-margin, innovative contrast agents.
  • Healthcare Providers: Need to balance safety, efficacy, and cost, favoring newer agents aligned with current clinical standards.
  • Investors: Must recognize the approaching market saturation and decline, adjusting valuation models accordingly.

Conclusion

The market dynamics for Ipodate calcium reflect a broader shift toward safer, more effective contrast media driven by technological innovation, regulatory scrutiny, and evolving clinical practices. Its financial outlook indicates a continued decline in revenue, with limited prospects for significant recovery or growth. Stakeholders must carefully assess strategic positioning in light of these trends to optimize resource allocation and investment decisions.


Key Takeaways

  • Market decline: Ipodate calcium’s market share diminishes due to competitive newer agents and technological advancements.
  • Regulatory and safety concerns: Ongoing safety evaluations and environmental impacts threaten further restrictions.
  • Limited growth prospects: Fading relevance outside niche applications results in negative revenue trajectories.
  • Strategic repositioning: Stakeholders should consider transitioning toward innovative contrast agents offering better safety and efficacy profiles.
  • Investment cautions: Diminishing revenues and market relevance advise conservative valuation and strategic planning.

FAQs

1. Why has Ipodate calcium's market share declined significantly?
Its decline results from competition from safer, low-osmolar, non-ionic contrast agents, along with advancements in imaging technology and regulatory factors favoring newer formulations.

2. Are there any regulatory restrictions on Ipodate calcium?
Yes. In certain markets, regulatory agencies have imposed restrictions or limited its approval due to safety concerns, environmental impact, or the availability of superior alternatives.

3. Can Ipodate calcium find applications in specific niche markets?
While possible, current applications are limited mainly to legacy procedures. The overall market potential remains low due to competition and clinical preference shifts.

4. What is the predicted sales trajectory for Ipodate calcium over the next five years?
Sales are projected to decline at a CAGR of roughly 8–12%, reflecting decreasing utilization, pricing pressures, and limited clinical application.

5. Should pharmaceutical companies consider reviving Ipodate calcium?
Given current trends and safety profiles, reinvestment in Ipodate calcium appears unviable unless supported by significant innovative repositioning or regulatory breakthroughs.

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