Last Updated: May 2, 2026

IOMEPROL - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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.

There is one drug master file entry for iomeprol. One supplier is listed for this compound.

Summary for IOMEPROL
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.

Recent Clinical Trials for IOMEPROL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Philippe GauthierN/A
GuerbetPhase 4
Deutsches Herzzentrum MuenchenPhase 4

See all IOMEPROL clinical trials

Pharmacology for IOMEPROL

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 216016-005 Nov 27, 2024 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco IOMERVU iomeprol SOLUTION;INTRAVENOUS 216017-013 Nov 27, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco IOMERVU iomeprol SOLUTION;INTRAVENOUS 216017-004 Nov 27, 2024 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco IOMERVU iomeprol SOLUTION;INTRAVENOUS 216017-007 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 Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

Iomeprol, a non-ionic, low-osmolar iodinated contrast medium, faces a mature market characterized by established competitors and evolving diagnostic imaging modalities. Its financial trajectory is primarily driven by global demand for CT and angiography procedures, regulatory approvals, and the competitive landscape of contrast agent pricing.

What is the Current Market Size and Growth Projection for Iomeprol?

The global market for iodinated contrast media, including iomeprol, is estimated to be in the multi-billion dollar range. The market is projected for steady, albeit moderate, growth over the next five to seven years. Growth is influenced by several factors:

  • Increasing Diagnostic Imaging Procedures: A rising prevalence of chronic diseases, an aging global population, and advancements in medical imaging technology contribute to a higher volume of diagnostic procedures, including those requiring contrast agents [1].
  • Geographic Expansion: Emerging economies are witnessing an increase in healthcare expenditure and access to advanced diagnostic tools, driving demand for contrast media in these regions.
  • Technological Advancements: While iomeprol is a well-established product, ongoing research in contrast agent formulation and delivery systems could influence market dynamics. However, significant disruptive innovations that would rapidly displace existing agents are not immediately apparent.
  • Competitive Landscape: The market is dominated by a few key players, and the competitive intensity impacts pricing strategies and market share distribution. Genericization of older contrast agents also plays a role in market segmentation.

Specific growth rates for iomeprol alone are difficult to isolate due to proprietary reporting by manufacturers. However, the overall iodinated contrast media market is generally projected to grow at a Compound Annual Growth Rate (CAGR) between 4% and 6% through 2028 [2].

Who are the Primary Manufacturers and Competitors of Iomeprol?

Iomeprol is primarily manufactured and marketed by Bracco Imaging S.p.A. Bracco is a significant global player in the diagnostic imaging sector.

Key competitors in the broader iodinated contrast media market include:

  • Bayer AG (Radiology division): A major competitor offering a range of iodinated and gadolinium-based contrast agents.
  • GE HealthCare: Offers a portfolio of contrast agents for various imaging applications.
  • Teva Pharmaceutical Industries Ltd.: A significant provider of generic pharmaceutical products, including some contrast media.
  • Other regional and specialty manufacturers: Smaller companies may compete in specific geographic markets or offer niche contrast agents.

The competitive strategy for iomeprol and similar agents focuses on:

  • Product Efficacy and Safety: Demonstrating a favorable risk-benefit profile.
  • Manufacturing Scale and Efficiency: Achieving cost-effective production to maintain competitive pricing.
  • Global Distribution Networks: Ensuring broad availability across healthcare systems.
  • Regulatory Compliance: Meeting the stringent requirements of health authorities worldwide.
  • Customer Support and Education: Providing resources to healthcare professionals regarding appropriate use and administration.

What is the Regulatory Status and Intellectual Property Landscape for Iomeprol?

Iomeprol has received regulatory approval in major markets, including the United States (FDA), Europe (EMA), and Japan (PMDA). Its approval status is crucial for its market access and continued sales.

  • FDA Approval: Iomeprol was approved by the U.S. Food and Drug Administration. Specific product names and indications are detailed in FDA approval documents.
  • EMA Approval: Iomeprol is authorized for use within the European Union.
  • Global Approvals: Similar authorizations exist in numerous other countries, facilitating international sales.

The patent landscape for iomeprol is critical for understanding its market exclusivity. As a compound developed and patented in earlier decades, the original patents protecting the iomeprol molecule have largely expired. This expiration has opened the door for:

  • Generic Competition: While Bracco remains a primary supplier, the expiry of core patents allows for the potential development and market entry of generic versions of iomeprol by other pharmaceutical manufacturers, provided they meet regulatory and bioequivalence standards.
  • Manufacturing Process Patents: Manufacturers may hold patents related to specific manufacturing processes, purification techniques, or formulations that could offer some degree of process protection.
  • Formulation and Delivery System Patents: Ongoing innovation may involve new formulations or delivery devices that could be subject to separate patent protection, potentially extending market exclusivity for specific product variations.

Bracco's continued market leadership for iomeprol relies on brand reputation, established supply chains, and potentially new intellectual property related to its manufacturing or formulation.

What are the Key Drivers and Restraints for Iomeprol's Market Performance?

Key Drivers:

  • Aging Population and Chronic Disease Burden: The global demographic shift towards an older population directly correlates with an increased incidence of conditions requiring advanced diagnostic imaging, such as cardiovascular diseases, cancers, and neurological disorders [3].
  • Advancements in Medical Imaging Technology: Continuous improvements in CT scanners, MRI machines, and angiography equipment enhance image resolution and diagnostic capabilities, leading to increased utilization of contrast agents to optimize these scans.
  • Growing Healthcare Infrastructure in Emerging Markets: Significant investments in healthcare facilities and diagnostic services in developing countries are expanding access to imaging procedures, creating new revenue streams for contrast media.
  • Established Clinical Track Record: Iomeprol has a long history of use, providing healthcare professionals with extensive data on its safety and efficacy, fostering trust and continued adoption.
  • Product Portfolio Diversification by Manufacturers: Companies like Bracco often offer a suite of contrast agents and related diagnostic tools, allowing for integrated solutions and cross-selling opportunities.

Key Restraints:

  • Pricing Pressures and Healthcare Cost Containment: Healthcare systems globally are under increasing pressure to control costs. This translates to intense price negotiations for all medical consumables, including contrast agents.
  • Competition from Other Contrast Media Types: While iomeprol is an iodinated agent, the market includes other types of contrast media, such as gadolinium-based agents for MRI, which compete for procedural volume based on diagnostic indications.
  • Emergence of Generic Alternatives: As patents expire, the threat of generic competition can significantly impact pricing and market share, particularly for well-established products.
  • Advancements in Non-Contrast Imaging Techniques: While imaging modalities like MRI and ultrasound do not always require contrast agents, ongoing research in improving their sensitivity and specificity could, in some diagnostic pathways, reduce the reliance on iodinated contrast media.
  • Potential for Contrast-Induced Nephropathy (CIN): While iomeprol is a low-osmolar agent with a relatively favorable safety profile, the risk of CIN in patients with pre-existing renal impairment remains a significant clinical consideration that can influence agent selection and procedural protocols.

What is the Financial Performance and Outlook for Iomeprol?

Financial performance for iomeprol is typically reported as part of a broader "Contrast Media" or "Diagnostic Imaging" segment by its manufacturers, rather than as a standalone product. However, based on market analysis and industry reports, the financial trajectory is characterized by:

  • Mature Market Revenue Streams: Iomeprol contributes stable, recurring revenue for Bracco. Growth is primarily volumetric, driven by increased procedure numbers, rather than significant price increases, given competitive pressures.
  • Cost Management is Key: Manufacturers focus on optimizing production costs, supply chain efficiency, and global logistics to maintain healthy profit margins in a price-sensitive market.
  • Geographic Market Penetration: Revenue growth is increasingly reliant on expanding market share in emerging economies where diagnostic imaging utilization is rising.
  • Impact of Product Mix: The overall financial performance of a manufacturer's contrast media portfolio is influenced by the sales mix between different agents (e.g., iomeprol versus newer or higher-margin products) and their respective pricing.
  • Long-Term Outlook: The outlook remains positive but moderate. Continued demand from aging populations and increased diagnostic imaging will support stable sales. However, aggressive price competition and the potential for generic entrants limit substantial revenue acceleration.

Projected Financial Trends:

  • Stable Revenue Growth: Expect continued, albeit modest, year-over-year revenue growth for iomeprol, aligned with the overall iodinated contrast media market CAGR.
  • Margin Stability: Profitability will likely be maintained through cost efficiencies and strategic pricing, rather than significant margin expansion.
  • Increased Competition Impact: As more regions see generic availability or as competitors introduce comparable products, price erosion may become more pronounced in certain markets.

Specific financial figures for iomeprol are proprietary to Bracco Imaging and are not publicly disclosed. However, industry analysis suggests that the iodinated contrast media market segment is a significant contributor to the overall revenues of major diagnostic imaging companies.

Key Takeaways

  • Iomeprol operates in a mature but growing market for iodinated contrast media, driven by increasing diagnostic imaging demand.
  • Bracco Imaging is the primary manufacturer, facing competition from global players like Bayer and GE HealthCare.
  • Original patents for iomeprol have expired, increasing the potential for generic competition.
  • Key growth drivers include an aging population and expanding healthcare infrastructure in emerging markets.
  • Restraints stem from intense pricing pressures, healthcare cost containment, and the threat of generic alternatives.
  • The financial outlook for iomeprol is characterized by stable revenue growth with a focus on cost management and geographic expansion.

FAQs

  1. What is the primary therapeutic indication for iomeprol? Iomeprol is a contrast agent used to enhance the visibility of internal bodily structures in diagnostic imaging procedures, primarily computed tomography (CT) scans and angiography, to aid in the detection and characterization of diseases.

  2. What are the main advantages of iomeprol compared to older contrast agents? Iomeprol is a non-ionic, low-osmolar contrast medium. This formulation generally leads to better patient tolerance, reduced risk of adverse reactions, and a more favorable safety profile, particularly concerning osmotic effects on physiological systems, compared to older ionic, high-osmolar agents.

  3. How does the patent expiry of iomeprol affect its market? The expiry of iomeprol's original composition-of-matter patents allows other pharmaceutical companies to develop and seek regulatory approval for generic versions of the drug. This can lead to increased market competition, price reductions, and potentially broader accessibility.

  4. What are the key geographical markets for iomeprol sales? Key markets include North America, Europe, and Japan, where advanced diagnostic imaging is widely utilized. Significant growth potential also exists in emerging markets in Asia-Pacific, Latin America, and the Middle East as their healthcare infrastructure develops.

  5. Are there any significant new technologies expected to disrupt the market for iomeprol in the near future? While ongoing research aims to improve contrast agent efficacy, safety, and delivery, no immediate disruptive technology is poised to rapidly displace established iodinated contrast media like iomeprol. Focus remains on incremental improvements in formulations, safety profiles, and manufacturing efficiencies.

Citations

[1] Global Market Insights. (2023). Iodinated Contrast Media Market Size, Share & Industry Analysis Report by Type (Ionic, Non-ionic), By Application (X-ray, CT, Angiography), By End-Use (Hospitals, Diagnostic Centers), By Region, And Segment Forecasts, 2024 – 2032. [2] Grand View Research. (2023). Iodinated Contrast Media Market Size, Share & Trends Analysis Report by Type (Ionic, Non-ionic), By Application (CT Scan, X-ray, Angiography), By End-use (Hospitals, Clinics, Diagnostic Centers), By Region, And Segment Forecasts, 2023 - 2030. [3] World Health Organization. (2022). Ageing and health.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.