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Last Updated: December 16, 2025

CONRAY Drug Patent Profile


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Which patents cover Conray, and what generic alternatives are available?

Conray is a drug marketed by Liebel-flarsheim and Mallinckrodt and is included in four NDAs.

The generic ingredient in CONRAY is iothalamate sodium. There is one drug master file entry for this compound. Additional details are available on the iothalamate sodium profile page.

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Summary for CONRAY
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Pharmacology for CONRAY

US Patents and Regulatory Information for CONRAY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Liebel-flarsheim CONRAY iothalamate meglumine INJECTABLE;INJECTION 013295-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mallinckrodt CONRAY 400 iothalamate sodium INJECTABLE;INJECTION 014295-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Liebel-flarsheim CONRAY 30 iothalamate meglumine INJECTABLE;INJECTION 016983-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mallinckrodt CONRAY 325 iothalamate sodium INJECTABLE;INJECTION 017685-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Liebel-flarsheim CONRAY 43 iothalamate meglumine INJECTABLE;INJECTION 013295-002 Approved Prior to Jan 1, 1982 DISCN Yes 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 the Pharmaceutical Drug: CONRAY

Last updated: July 27, 2025

Introduction

CONRAY, a pharmaceutical product developed by Conray (also known by its International Nonproprietary Name, meglumine amidotrizoate), is a contrast agent primarily used in diagnostic imaging. As a radiopaque medium, CONRAY's application spans across various imaging modalities, including angiography, urography, and hysterosalpingography. Understanding its market dynamics and financial trajectory entails analyzing regulatory landscapes, clinical utility, market competitors, and evolving healthcare needs that influence demand. This detailed review aims to elucidate the current position and future prospects of CONRAY within the broader imaging contrast agent sector.


Market Landscape

Global Contrast Agent Market Overview

The global contrast media market was valued at approximately USD 4.0 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4-5% over the next five years, driven by increasing diagnostic imaging procedures and technological advancements (Grand View Research, 2022). Within this landscape, iodine-based contrast agents—including CONRAY—constitute a significant share owing to their widespread use, cost-effectiveness, and established efficacy.

Product Positioning of CONRAY

CONRAY’s primary competitive advantage lies in its long-standing clinical track record, especially in specialized imaging. However, it faces competition from newer, lower-osmolar, and non-ionic contrast agents offering improved safety profiles. Despite these innovations, CONRAY remains relevant where cost and availability are critical, especially in developing markets.


Market Dynamics

Regulatory Environment

Regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) govern the approval, usage, and monitoring of contrast media. CONRAY's approval status varies across regions; in the U.S., it is classified as a prescription-only radiopaque agent with extensive safety and efficacy data. However, regulatory scrutiny concerning adverse reactions—such as nephrotoxicity—and evolving guidelines advocating lower-risk agents may influence future demand.

Clinical Utility and Safety Concerns

Although iodine-based contrast agents like CONRAY are effective, safety concerns persist. Acute adverse reactions often include allergies and nephrotoxicity, especially among vulnerable populations like those with renal impairment. The advent of non-ionic, iso-osmolar contrast agents has shifted some clinical preferences, but costs and clinical familiarity sustain demand for traditional agents like CONRAY.

Healthcare Infrastructure and Demand Drivers

The increasing global burden of chronic diseases requiring diagnostic imaging (cancer, cardiovascular, neurological disorders) bolsters demand for contrast agents. Investment in healthcare infrastructure, especially in emerging economies, further drives market growth. For CONRAY, regional adoption hinges on healthcare expenditure, availability, and physician familiarity.

Competitive Landscape

CONRAY faces competition from various iodine-based agents, such as Iohexol, Iodixanol, and Iopamidol, which are non-ionic and exhibit improved safety profiles. Biotech firms developing innovative contrast agents—e.g., those based on nanoparticles or alternative imaging modalities—pose longer-term challenges. Nonetheless, CONRAY's entrenched clinical utility and manufacturing legacy sustain its market position in certain segments.


Financial Trajectory

Sales and Revenue Trends

Historical sales data for CONRAY are limited publicly; however, being a legacy contrast agent, revenue streams are likely stable in markets where it maintains a preferential position due to cost, familiarity, and regulatory approval. In mature markets, growth may stagnate due to the shift towards newer agents, while emerging markets may provide expansion opportunities owing to cost sensitivities and infrastructural improvements.

Pricing and Cost Dynamics

CONRAY’s pricing remains relatively stable, given its generic status and widespread availability. Pricing pressures from healthcare systems emphasizing cost containment, along with patent expirations for some iodine contrast agents, influence margins. Manufacturers may adopt bulk production or strategic partnerships to sustain profitability.

Research and Development Investment

Limited R&D investment is observed for existing products like CONRAY; instead, companies focus on developing next-generation agents or alternative imaging techniques. However, incremental innovation—such as formulation improvements to enhance safety and reduce adverse reactions—could influence future market share and financial performance.

Potential Market Expansion and Risks

Opportunities for growth exist in underpenetrated regions, notably Asia-Pacific and Africa, where increasing healthcare investment and rising diagnostic needs can expand demand. Conversely, risks include regulatory restrictions on iodine-based contrast media due to safety concerns and competition from MRI or ultrasound alternatives that bypass contrast issues altogether.


Future Outlook

The future financial trajectory for CONRAY hinges on multiple factors:

  • Market Penetration in developing countries, driven by cost advantages and existing infrastructure.
  • Regulatory Environment, with potential restrictions on iodine contrast agents due to safety concerns.
  • Technological Shift toward advanced imaging modalities with cheaper, safer, or contrast-free options.
  • Corporate Strategic Initiatives, such as product line extensions or formulations targeting select patient populations.

In sum, while CONRAY’s core market may experience moderate decline owing to safety concerns and innovation, stable revenue streams and expansion in emerging markets may support a steady financial profile.


Key Takeaways

  • Market Segment: CONRAY remains a relevant contrast agent primarily in cost-sensitive regions and legacy clinical settings.
  • Growth Drivers: Increasing diagnostic imaging procedures and healthcare infrastructure investment in emerging economies fuel demand.
  • Challenges: Rising safety concerns, regulatory restrictions, and competition from non-iodine contrast media limit growth prospects.
  • Revenue Outlook: Stability in mature markets contrasted with potential growth in developing regions; reliance on cost advantages.
  • Strategic Actions: Manufacturers should explore formulary positioning, safety enhancements, and targeted marketing to sustain competitiveness.

FAQs

1. How does CONRAY compare to newer contrast agents in terms of safety?
CONRAY, as an iodine-based, high-osmolar contrast agent, has a higher risk of adverse reactions such as nephrotoxicity and allergies compared to non-ionic, iso-osmolar alternatives. Regulatory guidance increasingly favors safer, modern contrast media, which may impact demand for CONRAY in some markets.

2. What regions show the highest potential for CONRAY’s future growth?
Emerging markets in Asia-Pacific, Latin America, and Africa offer growth potential owing to expanding healthcare infrastructure, cost-sensitive procurement, and increasing demand for diagnostic imaging services.

3. What factors might hinder CONRAY’s market penetration going forward?
Safety profile concerns, regulatory restrictions, and the emergence of alternative imaging modalities that do not require contrast agents could hinder market growth for traditional iodine contrast media.

4. Are there ongoing innovations related to CONRAY?
Current innovations focus predominantly on new formulations to improve safety and reduce adverse reactions. However, large-scale R&D efforts specifically for CONRAY are limited, given the shift towards newer contrast agents.

5. How does regulatory approval impact CONRAY’s commercial prospects?
Regulatory approvals facilitate market access; adverse regulatory decisions or safety warnings can restrict sales. Conversely, maintaining approved status in key markets sustains revenue streams and competitive positioning.


Sources:
[1] Grand View Research, "Contrast Media Market Size & Trends," 2022.
[2] U.S. FDA, "Contrast Agents: Safety and Clinical Use," 2021.
[3] EvaluatePharma, "Healthcare & Pharmaceutical Market Data," 2022.

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