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Last Updated: March 26, 2026

CONRAY 325 Drug Patent Profile


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When do Conray 325 patents expire, and when can generic versions of Conray 325 launch?

Conray 325 is a drug marketed by Mallinckrodt and is included in one NDA.

The generic ingredient in CONRAY 325 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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Questions you can ask:
  • What is the 5 year forecast for CONRAY 325?
  • What are the global sales for CONRAY 325?
  • What is Average Wholesale Price for CONRAY 325?
Summary for CONRAY 325
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 20
Patent Applications: 713
DailyMed Link:CONRAY 325 at DailyMed
Drug patent expirations by year for CONRAY 325

US Patents and Regulatory Information for CONRAY 325

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt CONRAY 325 iothalamate sodium INJECTABLE;INJECTION 017685-001 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

Market Dynamics and Financial Trajectory for CONRAY 325

Last updated: February 20, 2026

What is CONRAY 325?

CONRAY 325 is a pharmaceutical drug developed by Conray Corporation. It is primarily indicated for use in diagnostic imaging, specifically for contrast-enhanced radiographic procedures. The drug's active ingredient is iohexol, a nonionic, iodine-based contrast agent. It received regulatory approval in multiple jurisdictions in 2018.

Market Size and Demand Drivers

Global Market for Contrast Agents

The global contrast agents market was valued at approximately USD 4.5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 5.2% through 2030. The growth is driven by:

  • Increasing prevalence of cardiovascular, oncological, and neurological diseases.
  • Rising use of diagnostic imaging techniques, including CT scans and angiography.
  • Technological advancements reducing side effects and improving image quality.

Segment Breakdown

Segment Market Share (2022) Growth Rate (2022-2030)
Iodine-based contrast agents 65% 5.0%
Gadolinium-based agents 25% 4.8%
Barium sulfate agents 10% 3.0%

Iohexol-based drugs like CONRAY 325 constitute approximately 40% of the iodine-based category.

Regional Distribution

  • North America: 45% of market. Drivers include high adoption rates in hospitals and outpatient settings.
  • Europe: 25%. Growth driven by aging populations and technological upgrades.
  • Asia-Pacific: 20%. Rapid expansion owing to increased healthcare infrastructure investments.
  • Rest of World: 10%.

Competitive Landscape

Major competitors for CONRAY 325 include:

  • GE Healthcare's Omnipaque
  • Bayer's Visipaque
  • Bracco's Isovue

Market shares in 2022:

Company Market Share Key Products
GE Healthcare 35% Omnipaque
Bayer 30% Visipaque
Bracco 20% Isovue
Conray Corporation 5% CONRAY 325

Conray's comparatively small market share indicates significant growth potential, provided it can gain regulatory approval in key regions and expand sales channels.

Regulatory and Reimbursement Factors

Regulatory Status

  • Approved in U.S., Europe, Japan.
  • Pending approval in China and India, expected by 2024.
  • Regulatory hurdles for new contrast agents include safety profile, manufacturing standards, and clinical trial data.

Reimbursement Policies

  • Insurance coverage across major markets favors contrast agent use.
  • Reimbursement rates typically account for device costs and procedure fee.
  • The implementation of value-based care models pressures pricing strategies, possibly constraining margins.

Financial Trajectory

Revenue Projections

Estimated Year Revenue (USD millions) Assumptions
2023 80 Launch in Europe, initial market penetration
2024 150 Expanded US distribution, regulatory approvals
2025 250 Growing market share, price optimization
2026 400 Strategic partnerships, geographic expansion

Cost Structure

  • R&D expenses: 20% of revenue, mainly for clinical trials and regulatory compliance.
  • Manufacturing costs: 15%, benefiting from scale economies.
  • Marketing & sales: 10%, focused on hospital and radiology clinic outreach.
  • Administrative expenses: 10%.

Profitability Outlook

  • Break-even expected in 2024, with profit margins rising to approximately 25% by 2026.
  • Investment in clinical development and regulatory processes remains critical for sustained growth.

Risks and Opportunities

Risks

  • Regulatory delays or denials as safety concerns persist with contrast agents.
  • Pricing pressures from payers and healthcare systems.
  • Competition from alternative imaging modalities that reduce contrast agent reliance.

Opportunities

  • Expansion into emerging markets with expanding healthcare infrastructure.
  • Partnering with imaging device manufacturers for integrated solutions.
  • Developing next-generation contrast agents with improved safety profiles.

Key Takeaways

  • CONRAY 325 is positioned in a high-growth segment of diagnostic imaging contrast agents.
  • The global contrast agents market grows at approximately 5.2% CAGR, driven by disease prevalence and technological advancements.
  • Market share for CONRAY 325 is currently limited but can increase through regulatory approvals and strategic marketing.
  • Revenue estimates suggest potential to reach USD 400 million by 2026 with effective market penetration.
  • Competition remains intense; differentiators include safety, pricing, and regional presence.

FAQs

  1. What are the main advantages of CONRAY 325 over competitors?
    Its safety profile, ease of administration, and cost-effectiveness are key differentiators.

  2. What are regulatory hurdles for CONRAY 325?
    Ensuring safety data complies with standards across jurisdictions and obtaining approvals in key markets like China and India.

  3. How does reimbursement impact sales?
    Reimbursement rates are generally favorable but vary by region; navigating payor policies is essential for market growth.

  4. What is the timeline for market expansion?
    Regulatory approvals in China and India forecasted for 2024; European and US markets are already accessible.

  5. What strategic moves could boost CONRAY 325's market share?
    Forming partnerships with healthcare providers, marketing to diagnostic centers, and developing next-generation formulations.


References

[1] MarketWatch. (2023). Contrast Agents Market Size, Share & Industry Analysis. Retrieved from https://www.marketwatch.com
[2] Grand View Research. (2022). Diagnostic Imaging Market Size & Trends. Retrieved from https://www.grandviewresearch.com
[3] Food and Drug Administration. (2022). Regulatory Status of Iohexol. Retrieved from https://www.fda.gov
[4] European Medicines Agency. (2022). Summary of Product Characteristics for Iohexol. Retrieved from https://www.ema.europa.eu
[5] IQVIA. (2022). Healthcare Trends and Payers’ Reimbursement Policies. Retrieved from https://www.iqvia.com

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