Last Updated: May 3, 2026

iomeprol - Profile


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

Iomeprol is the generic ingredient in one branded drug marketed by Bracco and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for iomeprol
US Patents:0
Tradenames:1
Applicants:1
NDAs:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for iomeprol
Generic Entry Dates for iomeprol*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
SOLUTION;INTRA-ARTERIAL
Generic Entry Dates for iomeprol*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for iomeprol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco IOMERVU iomeprol SOLUTION;INTRA-ARTERIAL 216016-002 Nov 27, 2024 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco IOMERVU iomeprol SOLUTION;INTRA-ARTERIAL 216016-006 Nov 27, 2024 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco IOMERVU iomeprol SOLUTION;INTRA-ARTERIAL 216016-010 Nov 27, 2024 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco IOMERVU iomeprol SOLUTION;INTRA-ARTERIAL 216016-001 Nov 27, 2024 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco IOMERVU iomeprol SOLUTION;INTRA-ARTERIAL 216016-003 Nov 27, 2024 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco IOMERVU iomeprol SOLUTION;INTRA-ARTERIAL 216016-007 Nov 27, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco IOMERVU iomeprol SOLUTION;INTRA-ARTERIAL 216016-011 Nov 27, 2024 RX Yes Yes ⤷  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

Iomeprol Market Analysis and Financial Projection

Last updated: February 10, 2026

What is the current market position of iomeprol?

Iomeprol is a non-ionic iodinated contrast agent used in medical imaging procedures, primarily for X-ray and CT scans. It is marketed under various brand names globally and competes within a category of contrast media that includes iohexol, ioversol, and iohexol. The global contrast media market was valued at approximately $4.0 billion in 2022, with a compound annual growth rate (CAGR) of around 4.3% projected through 2027 [1].

Iomeprol's market share remains niche relative to its competitors, owing to brand recognition, regulatory approvals, and physician preference. It is primarily used in hospitals and imaging centers in Europe, Asia-Pacific, and select North American markets.

What are the key factors influencing investment and fundamental valuation?

Market Dynamics

The contrast media market's growth hinges on several factors:

  • Rising prevalence of chronic diseases necessitating diagnostic imaging.
  • Increased adoption of CT and MRI procedures globally.
  • Technological advancements in imaging equipment.
  • Regulatory policies affecting branded patent protections and generic competition.

The market faces regulatory challenges when introducing new contrast media or biosimilars, which can impact future growth.

Competitive Landscape

Major competitors include:

  • Iohexol (Omnipaque, Geide, others)
  • Ioversol (Optiray)
  • Iodixanol (Visipaque)

Market incumbents benefit from established relationships with healthcare providers and existing supply contracts. New entrants or generic manufacturers face barriers such as regulatory approval costs and brand loyalty.

Regulatory and Patent Landscape

Iomeprol's patent exclusivity has largely expired or will soon expire, opening pathways for generic manufacturing. Regulatory approvals are maintained by agencies such as the FDA, EMA, and PMDA, which influence market access and pricing.

R&D and Pipeline

Development of new contrast agents with improved safety profiles (e.g., reduced nephrotoxicity, allergic reactions) could impact iomeprol's market share. Investment in cutting-edge formulations or delivery systems constitutes a strategic avenue.

Pricing and Reimbursement

Pricing strategies are pivotal in profit margins. Reimbursement policies in major markets influence end-user demand, with non-ionic contrast media generally reimbursed at higher rates than ionic alternatives.

Manufacturing and Supply Chain

Manufacturing capabilities, supply chain stability, and quality control determine margins and market reliability. Supply disruptions could impact revenue.

What financial fundamentals and valuation metrics are relevant?

Revenue Trends

Global contrast media sales have been steady with moderate growth; specific sales figures for iomeprol are scarce due to limited public disclosures. Industry estimates suggest the contrast media segment grew by roughly 4% annually, with branded products maintaining higher margins.

Cost Structure

Production involves iodinated organic compounds, solvents, and specialized packaging. R&D investment is less significant for mature products but necessary for regulatory compliance and formulation improvements.

Profitability Metrics

Gross margins for contrast media typically range between 70-80%. Operating margins vary based on marketing, distribution, and R&D expenditures.

Investment Returns

Companies involved in contrast media manufacturing report EBITDA margins between 30-40%. Key ratios include:

  • Price-to-Earnings (P/E): Dependent on company-specific earnings, often in the range of 10-20 for mature firms.
  • Price-to-Sales (P/S): Usually 2-4 in this sector.
  • Free Cash Flow (FCF): Important for assessing capacity to fund R&D and new product development.

Strategic Valuation Approaches

Valuations focus on discounted cash flow (DCF) models incorporating anticipated market growth, competitive dynamics, and patent expiration timelines. Scenario analysis considers different regulatory and pricing environments.

What are the investment risks associated with iomeprol?

  • Patent expiry leading to generic competition.
  • Regulatory hurdles delaying product approvals.
  • Market saturation with existing contrast media.
  • Reputational risks tied to safety and adverse event reports.
  • Supply chain vulnerabilities, especially for raw iodine compounds.

Key considerations for prospective investors

  • Monitor patent expiration timelines and generic entry.
  • Evaluate pipeline developments for new contrast agents.
  • Assess regulatory environment impacts on pricing and reimbursement.
  • Analyze company market share trends and sales data.
  • Consider potential market growth driven by increasing imaging procedures.

Key Takeaways

  • Iomeprol operates in a competitive, mature segment with steady demand driven by global imaging needs.
  • Patent expirations are imminent or ongoing, opening opportunities for generics but heightening competition.
  • Financial margins are robust but sensitive to regulatory changes and market share shifts.
  • Strategic investments should focus on pipeline innovation and regulatory navigation.
  • Market expansion opportunities exist within emerging markets with increasing healthcare infrastructure.

Frequently Asked Questions

1. When will patent protection for iomeprol expire?

Most patents for iomeprol have expired or are nearing expiration, expected around 2024-2026, enabling generic manufacturing opportunities.

2. How does the safety profile of iomeprol compare to competitors?

It is generally considered safe but shares similar risks of allergic reactions and nephrotoxicity with other non-ionic contrast media; ongoing safety improvements are a focus area.

3. What are the key regulatory hurdles for new contrast agents?

Regulatory agencies require demonstration of safety, efficacy, and manufacturing quality, with specific concern for adverse reactions and environmental impact.

4. How does reimbursement influence iomeprol sales?

Reimbursement policies that favor non-ionic contrast media support sustained demand, but pricing pressures can affect margins, especially with increased generic competition.

5. What market segments are most promising for growth?

Emerging markets with expanding healthcare infrastructure and increasing access to advanced imaging techniques represent growth opportunities.

References

[1] MarketsandMarkets, “Contrast Media Market,” 2022.

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