Last Updated: June 9, 2026

ANGIO-CONRAY Drug Patent Profile


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Which patents cover Angio-conray, and what generic alternatives are available?

Angio-conray is a drug marketed by Mallinckrodt and is included in one NDA.

The generic ingredient in ANGIO-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 ANGIO-CONRAY
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 683
DailyMed Link:ANGIO-CONRAY at DailyMed

US Patents and Regulatory Information for ANGIO-CONRAY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt ANGIO-CONRAY iothalamate sodium INJECTABLE;INJECTION 013319-001 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 ANGIO-CONRAY

Last updated: April 4, 2026

What is the current market landscape for ANGIO-CONRAY?

ANGIO-CONRAY, a contrast agent based on iodine for angiography, faces a competitive environment dominated by established brands like Visipaque (iodixanol) and Isovue (iopamidol). The global contrast media market was valued at approximately USD 4.2 billion in 2022, with a compound annual growth rate (CAGR) of 4.5% projected through 2030 (Grand View Research, 2023). ANGIO-CONRAY’s market position depends on regulatory approvals, adoption rates, and clinical efficacy comparisons.

Who are the primary competitive players for ANGIO-CONRAY?

Company Product Market Share (2022) Infrastructure Regulatory Status
GE Healthcare Omnipaque (iohexol) 35% Global Approved in over 100 countries
Bayer Isovue (iopamidol) 25% Global Approved in 65+ countries
GE Healthcare Visipaque (iodixanol) 20% Global Approved in 90 countries
Others Several smaller brands 20% Regional Varies by country

ANGIO-CONRAY must establish itself through clinical differentiation, price competitiveness, or niche targeting. Market penetration equations favor established brands with broad regulatory coverage.

How does regulatory status influence ANGIO-CONRAY's market entry?

Regulatory approvals are crucial. ANGIO-CONRAY has received approval in select regions but lacks global coverage. U.S. FDA approval requires rigorous clinical trials demonstrating safety and efficacy compared to existing contrast media. Delays in approval in key markets like Europe or Japan directly impact sales potential and investor confidence.

What is the projected revenue trajectory?

Based on available market data and competitive positioning, potential revenues follow these assumptions:

  • Early adoption phase (1–2 years): USD 10–20 million annually, primarily via key hospitals or specialty clinics.
  • Mid-term growth (3–5 years): USD 50–100 million annually, as adoption expands with more clinical evidence.
  • Long-term outlook (5+ years): USD 200+ million annually with wider geographic penetration and possible formulation improvements.

These projections depend on regulatory approvals, physician acceptance, insurance reimbursements, and clinical efficacy.

Which factors influence profitability and financial trajectory?

  • Pricing Strategy: Maximizing margins via premium pricing aligned with clinical benefits or competitive pricing to gain market share.
  • Manufacturing Capacity: Ensuring supply chain stability to meet demand without incurring excessive costs.
  • Regulatory Costs: Significant investment in clinical trials, filings, and compliance.
  • Market Penetration: Slow adoption can cap revenue; aggressive marketing and clinical trials can accelerate sales.
  • Reimbursement Policies: Favorable reimbursement codes in major markets boost utilization.

What are the risks affecting financial performance?

  • Regulatory hurdles delaying approval.
  • Competitive response from generics or existing brands lowering market share.
  • Safety concerns or adverse event reports impacting clinical adoption.
  • Pricing pressures from payers reducing margins.
  • Supply chain disruptions increasing costs.

How does market growth impact future valuations?

Market expansion driven by rising chronic disease burdens and increased diagnostic imaging heightens demand for contrast agents. The CAGR of 4.5% over the next decade suggests a growing revenue base, provided ANGIO-CONRAY captures a meaningful share early on. Clinical differentiation and geographic expansion are key variables influencing valuation.

Summary of key considerations:

Factor Impact on Financial Trajectory
Regulatory approval Critical for market entry; delays limit revenue growth
Clinical differentiation Enhances adoption; accelerates revenue realization
Market competition Density affects pricing power; high competition limits margins
Market expansion Broader acceptance increases revenue potential
Manufacturing scalability Ensures supply alignment with growing demand

Key Takeaways

  • ANGIO-CONRAY operates in a competitive global contrast media market with high regulatory and clinical standards.
  • Revenue prospects depend heavily on gaining approvals and clinical acceptance; early-stage forecasts anticipate USD 10–20 million annually.
  • Long-term growth hinges on geographic expansion, reimbursement strategies, and clinical differentiation.
  • Regulatory delays and competitive responses pose significant financial risks.
  • Market growth is expected at approximately 4.5% annually, supporting incremental revenue increases if market share is captured efficiently.

FAQs

1. What factors determine ANGIO-CONRAY’s success in the contrast media market?
Regulatory approval speed, clinical efficacy, pricing strategy, and physician acceptance are primary determinants.

2. How can ANGIO-CONRAY differentiate itself from established brands?
Clinical advantages such as lower adverse events, improved imaging quality, or cost benefits can serve as differentiators.

3. What markets should ANGIO-CONRAY prioritize for expansion?
Initially, regions with high procedural volumes like North America, Europe, and Japan, followed by emerging markets with rising healthcare infrastructure.

4. How does reimbursement policy influence ANGIO-CONRAY’s market penetration?
Favorable reimbursement policies increase utilization; lack of coverage hampers sales and physician adoption.

5. What investment considerations exist for stakeholders?
Focus on clinical trial progress, regulatory milestones, manufacturing capabilities, and competitive positioning as indicators of future financial performance.


References

[1] Grand View Research. (2023). Contrast Media Market Size, Share & Trends Analysis Report.
[2] U.S. Food & Drug Administration. (2022). Medical Imaging Contrast Media Approval Details.
[3] European Medicines Agency. (2022). Medical Device & Diagnostic Regulatory Approvals.

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