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Last Updated: December 19, 2025

Iomeprol - Generic Drug Details


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What are the generic drug 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.

Summary for iomeprol
US Patents:0
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 1
Clinical Trials: 3
Patent Applications: 2,896
DailyMed Link:iomeprol at DailyMed
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

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 216016-001 Nov 27, 2024 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bracco IOMERVU iomeprol SOLUTION;INTRA-ARTERIAL 216016-009 Nov 27, 2024 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bracco IOMERVU iomeprol SOLUTION;INTRAVENOUS 216017-012 Nov 27, 2024 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bracco IOMERVU iomeprol SOLUTION;INTRAVENOUS 216017-013 Nov 27, 2024 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bracco IOMERVU iomeprol SOLUTION;INTRA-ARTERIAL 216016-002 Nov 27, 2024 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bracco IOMERVU iomeprol SOLUTION;INTRAVENOUS 216017-003 Nov 27, 2024 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bracco IOMERVU iomeprol SOLUTION;INTRAVENOUS 216017-006 Nov 27, 2024 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 Iomeprol

Last updated: July 28, 2025

Introduction

Iomeprol, a novel non-ionic iodinated contrast agent, is primarily used in diagnostic imaging procedures such as computed tomography (CT) scans. As the demand for advanced imaging modalities increases globally, the pharmaceutical landscape for contrast agents like Iomeprol is experiencing notable shifts. This article examines the market dynamics influencing Iomeprol’s growth trajectory and evaluates its financial outlook amid evolving healthcare needs, regulatory environments, and competitive pressures.

Market Overview of Contrast Agents

Contrast agents are integral to modern diagnostic radiology, with iodinated compounds comprising the majority of intravenous contrast media (ICM) due to their efficacy and safety profiles. The global contrast media market was valued at approximately USD 4.3 billion in 2021 and is projected to expand at a compound annual growth rate (CAGR) of 4-6% through 2030[1].

Iomeprol belongs to the third-generation non-ionic contrast agents characterized by lower osmolality, reduced adverse reactions, and improved patient tolerability. These attributes have driven their adoption across both developed and emerging markets, positioning Iomeprol as a key player within this segment.

Market Dynamics Influencing Iomeprol

1. Growing Imaging Procedure Volumes

The global increase in diagnostic imaging procedures, particularly CT scans, directly bolsters demand for contrast agents like Iomeprol. Factors contributing include aging populations, rising prevalence of chronic diseases, and technological advancements lowering imaging costs. The World Health Organization reports a 60% increase in CT procedures over the past decade, with projections indicating continued growth[2].

2. Advancements in Contrast Agent Technology

The shift from high-osmolality to low-osmolality contrast media (LOCM) has augmented safety and patient compliance, influencing the adoption of agents like Iomeprol. Its non-ionic, low-osmolality profile aligns with new standards emphasizing safety, thereby expanding its market share.

3. Regulatory and Reimbursement Landscape

Stringent regulatory standards, especially in North America and Europe, require comprehensive safety and efficacy data for contrast agents. The approval processes, however, are well-established for products like Iomeprol. Additionally, insurance reimbursement policies favor cost-effective, low-adverse-effect agents, which supports the market penetration of Iomeprol.

4. Competitive Pressures and Genericization

Major players such as GE Healthcare, Bracco, and Guerbet dominate the contrast agent space. The active patent expiry of key formulations has introduced generics, intensifying price competition. While Iomeprol retains proprietary formulations in certain regions, price erosion is inevitable, affecting revenue growth potential.

5. Emergence of Alternative Imaging Modalities

The development of magnetic resonance imaging (MRI) and ultrasound as alternatives can impact contrast media demand. However, CT remains indispensable in many diagnostic scenarios, ensuring steady demand for iodinated contrast agents like Iomeprol.

6. Safety Profile and Adverse Reaction Management

Iomeprol's favorable safety profile minimizes contrast-induced nephropathy (CIN) and allergic reactions, critical factors in patient choice and physician prescribing behavior. Continuous evidence supporting safety enhances its market position.

7. Geographic and Demographic Factors

Emerging markets, notably Asia-Pacific, show increasing adoption due to expanding healthcare infrastructure and rising diagnostic imaging rates. Conversely, mature markets witness saturation, hampering growth but providing stable revenues.

Financial Trajectory of Iomeprol

Revenue Streams and Market Share

Iomeprol's revenue is derived predominantly from institutional sales to hospitals and diagnostic centers. Market surveys indicate a steady but competitive position owing to its safety profile. While exact sales figures are proprietary, estimates suggest that Iomeprol accounts for an estimated 12-15% of the iodinated contrast media market segment.

Pricing Trends and Profitability

Price erosion attributable to generic competition constrains profit margins. Manufacturers are emphasizing product differentiation through formulations that mitigate adverse reactions and enhance reliability, which can command premium pricing margins.

Research and Development Investment

Continuous R&D efforts aim to develop next-generation contrast agents with materials that reduce adverse effects further or enable adjunct diagnostic capabilities, which can sustain or uplift Iomeprol’s market relevance.

Regulatory and Market Expansion Strategies

Expanding regulatory approvals in emerging markets and maintaining compliance with safety standards are critical to market expansion. Strategic partnerships and licensing agreements often enhance distribution channels and revenues.

Future Growth Projections

Considering the compounded effects of increased procedure volume, technological advances, and regulatory stability, the global demand for Iomeprol is expected to grow at an annual rate of approximately 4-5% over the next five years[3]. However, price competition and patent cliffs may temper revenue growth, necessitating diversification and innovation.

Challenges and Opportunities

Challenges

  • Price Competition: Entry of generics reduces revenue potential.
  • Market Saturation: Developed markets approaching maturity.
  • Alternative Modalities: MRI and ultrasound reducing iodinated contrast dependence.
  • Regulatory Hurdles: Compliance costs and approval delays in certain regions.

Opportunities

  • Emerging Market Expansion: Increased healthcare infrastructure creates growth prospects.
  • Innovative Formulations: Developing agents with superior safety profiles commands premium pricing.
  • Value-added Solutions: Combining imaging agents with ancillary diagnostic tools can enhance market appeal.
  • Personalized Medicine: Tailoring contrast media to patient profiles improves outcomes and market differentiation.

Conclusion

The market dynamics for Iomeprol are shaped by technological innovations, demographic trends, and competitive forces. While the demand driven by rising imaging procedures remains robust, pricing pressures and alternative imaging modalities pose challenges. Strategic investments in R&D, geographic expansion, and safety enhancements are key to sustaining its financial trajectory. Overall, Iomeprol’s growth outlook remains positive within the context of the expanding global imaging market but requires prudent execution to navigate competitive and regulatory landscapes.


Key Takeaways

  • The global contrast media market is expected to grow at 4-6% CAGR, driven by increased imaging procedures.
  • Iomeprol’s non-ionic, low-osmolality profile aligns with safety trends in diagnostic imaging.
  • Patent expiries and generic introductions exert downward pressure on prices and margins.
  • Emerging markets offer significant growth opportunities, supported by infrastructural development.
  • Innovation in formulations and expanding indications will be pivotal for long-term revenue stability.

FAQs

1. What distinguishes Iomeprol from other iodinated contrast agents?
Iomeprol features a non-ionic, low-osmolality formulation, resulting in reduced adverse reactions and improved patient tolerability compared to older high-osmolality agents.

2. How does patent expiration affect Iomeprol’s market?
Patent expiries lead to the introduction of generic formulations, increasing competition and exerting downward pressure on prices, which can impact revenue and profitability.

3. What are the primary growth drivers for Iomeprol?
Increasing volumes of CT imaging, technological advancements, expanding healthcare infrastructure in emerging markets, and a favorable safety profile propel demand.

4. What challenges does Iomeprol face in the current market?
Market saturation in developed regions, competition from generics, alternative imaging modalities like MRI, and regulatory hurdles are significant challenges.

5. How can makers of Iomeprol sustain their market position?
By investing in R&D for safer, more efficient agents, expanding geographic presence, and establishing partnerships, they can differentiate their offerings and capture new markets.


Sources:

[1] MarketsandMarkets, "Contrast Media Market," 2022.
[2] WHO, "Global Diagnostic Imaging Trends," 2021.
[3] Allied Market Research, "Contrast Media Market Forecast," 2022.

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