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IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM - Generic Drug Details
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What are the generic drug sources for iothalamate meglumine; iothalamate sodium and what is the scope of patent protection?
Iothalamate meglumine; iothalamate sodium
is the generic ingredient in one branded drug marketed by Mallinckrodt and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| DailyMed Link: | IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM at DailyMed |
US Patents and Regulatory Information for IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mallinckrodt | VASCORAY | iothalamate meglumine; iothalamate sodium | INJECTABLE;INJECTION | 016783-001 | 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 Iothalamate Meglumine and Iothalamate Sodium
Introduction
Iothalamate meglumine and iothalamate sodium are contrast agents primarily used in diagnostic imaging procedures such as angiography, myelography, and computed tomography (CT). Their high iodine content enables detailed visualization of vascular and soft tissue structures, facilitating accurate diagnoses. As the demand for advanced imaging techniques grows globally, understanding the market dynamics and financial trajectory of these agents becomes critical for stakeholders across pharmaceutical, healthcare, and investment sectors.
Market Overview
The global contrast media market, encompassing both iodinated contrast agents like iothalamate derivatives and alternative imaging solutions, is projected to expand at a compound annual growth rate (CAGR) of approximately 4.3% from 2022 to 2030, driven by increasing diagnostic imaging procedures and technological innovations (source: MarketsandMarkets). Despite a mature market landscape for traditional contrast agents, niche segments emphasizing high-quality imaging and safety features are gaining prominence.
Iothalamate meglumine and iothalamate sodium occupy a specialized segment within iodinated contrast media (ICM), competing against newer agents such as non-ionic, low-osmolar contrast agents. Their legacy status persists given established efficacy and familiarity among radiologists but faces ongoing competition from innovations aimed at reducing adverse reactions.
Market Drivers
Growth in Diagnostic Imaging Procedures
The global rise in diagnostic imaging—particularly angiography, neuroimaging, and cancer diagnostics—augments demand for high-contrast agents. The increasing prevalence of cardiovascular diseases and neurological disorders amplifies the need for detailed vascular and neural imaging, directly correlating with the utilization of iothalamate-based contrast agents.
Advancements in Imaging Technology
Enhanced imaging modalities, including digital subtraction angiography and high-resolution CT, demand contrast agents with superior attenuation properties. Iothalamate meglumine's high iodine concentration ensures optimal image clarity, reinforcing its continued relevance in clinical practice.
Regulatory and Clinical Acceptance
Regulatory bodies like the FDA and EMA have historically approved iothalamate agents for specific procedures, aiding market stability. In many regions, clinicians prefer familiar contrast agents due to extensive safety data, solidifying their market position despite emerging alternatives.
Market Penetration in Emerging Economies
Rising investments in healthcare infrastructure in Asia-Pacific and Latin America expand access to advanced diagnostic procedures. Localized use of established contrast agents like iothalamate enhances their regional market share, especially where newer agents are not yet widespread due to cost or regulatory hurdles.
Market Challenges
Safety and Adverse Effects
The primary limitation of iothalamate agents lies in their high osmolarity, which can precipitate adverse reactions such as nephrotoxicity, allergic responses, and discomfort. These safety concerns have prompted the global shift toward low-osmolar and iso-osmolar contrast media, constricting the growth trajectory of traditional agents.
Emergence of Alternative Contrast Media
Non-iodinated contrast agents and newer iodinated options with improved safety profiles are slowly displacing traditional agents. Additionally, advances in magnetic resonance imaging (MRI) and ultrasound reduce reliance on iodinated contrast, potentially impacting market growth.
Regulatory and Manufacturing Constraints
Stringent quality standards and patent expirations influence market dynamics. Manufacturing complexities inherent to iodine-based agents result in higher production costs and potential supply chain vulnerabilities, impacting profitability.
Financial Trajectory and Market Forecast
The financial outlook for iothalamate meglumine and sodium hinges on multiple factors, including regulatory approvals, clinical adoption rates, and competitive pressures.
Revenue Trends
Historically, sales of these contrast agents have been stable within specialized institutions. However, broader market penetration is constrained, with annual revenues in developed markets plateauing or declining modestly due to competition from low-osmolar alternatives. In 2022, the global sales of iodinated contrast media approached approximately USD 2.2 billion, with traditional agents accounting for about 30–35%, indicating a gradual decline as newer agents capture market share (source: EvaluatePharma).
Pricing Dynamics
Pricing strategies are influenced by the agent’s formulation (meglumine vs. sodium), concentration, and region. While legacy agents often command premium pricing due to brand recognition, increased competition and patent expirations pressure margins, especially in commoditized markets.
Regional Variations
In North America and Europe, high regulatory standards and the prevalence of safety-conscious prescribing have reduced reliance on high-osmolar agents. Conversely, regions with expanding healthcare infrastructure and cost-sensitive markets may witness sustained utilization of iothalamate agents, albeit at lower growth rates.
Future Projections
Given the clinical safety concerns and technological shifts, the market for iothalamate meglumine and sodium is projected to decline modestly at a CAGR of approximately 1-2% through 2030 in mature markets. Conversely, in emerging regions, where medical infrastructure is developing, these agents may sustain steady demand, contributing to regional variations in growth.
Market Entrants and Competitive Landscape
Major pharmaceutical companies with a longstanding presence in contrast media manufacturing include GE Healthcare, Bracco Imaging, and Guerbet. These corporations are actively investing in research to develop safer, lower-osmolar contrast agents, which may further erode market share for traditional agents.
Generic manufacturers also play a role, often providing cost-effective alternatives in secondary markets. Patent expirations have facilitated increased generic competition, exerting downward pressure on pricing and margins.
Regulatory and Technological Trends
Regulatory agencies are increasingly emphasizing patient safety, prompting manufacturers to innovate. Initiatives include developing iso-osmolar agents with reduced nephrotoxicity, leading to potential niche market strengthening for high-quality contrast media.
Simultaneously, the surge in MRI and ultrasound usage—without contrast or using agent-specific contrast media—gradually diminishes the overall market size for traditional iodinated agents like iothalamate.
Key Takeaways
- The global contrast media market is growing, driven chiefly by increased demand for diagnostic imaging and technological advancements.
- Iothalamate meglumine and iothalamate sodium are entrenched in specific clinical niches but face declining usage due to safety concerns and technological competition.
- Revenue trajectories indicate stabilization or modest decline in developed markets, with emerging economies maintaining steady demand.
- Market competition is intensifying due to patent expirations, generic entries, and the rise of safer alternatives, compelling price pressures.
- Innovation focused on safety and efficacy is critical for maintaining relevance; companies investing in next-generation contrast agents will influence future financial trajectories.
FAQs
1. What factors primarily influence the declining market share of traditional iodinated contrast agents like iothalamate?
The shift towards low-osmolar and iso-osmolar contrast media, driven by safety concerns such as nephrotoxicity and allergic reactions, alongside the advent of MRI and ultrasound imaging, have reduced reliance on traditional agents like iothalamate.
2. How does regional variation affect the sales of iothalamate contrast agents?
In developed regions (North America, Europe), regulatory standards and safety awareness diminish their usage, favoring newer agents. Conversely, in emerging markets, cost considerations and infrastructure development sustain their demand.
3. What innovations could potentially reverse the declining trend for these contrast agents?
Developing safer, lower-osmolar, and more biocompatible formulations could bolster their market. Additionally, integrating new delivery systems and expanding their application scope may provide growth opportunities.
4. Are there any regulatory challenges affecting the production and sale of iothalamate agents?
Regulatory agencies emphasize patient safety, requiring stringent testing and quality standards, which can increase manufacturing costs and limit production flexibility, affecting market competitiveness.
5. What is the future outlook for pharmaceutical companies heavily invested in traditional contrast media?
They must innovate and diversify their portfolios, emphasizing safety and efficacy. Companies that invest in next-generation contrast agents or diversify into alternative imaging pharmaceuticals are better positioned for future growth.
Sources:
[1] MarketsandMarkets. Contrast Media Market Size & Share Analysis. 2022.
[2] EvaluatePharma. Global contrast media sales data. 2022.
[3] FDA. Guidance for Industry: Safety of Iodinated Contrast Media. 2019.
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