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Last Updated: March 26, 2026

Guerbet Company Profile


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Summary for Guerbet
International Patents:86
US Patents:3
Tradenames:6
Ingredients:5
NDAs:5
Drug Master File Entries: 1

Drugs and US Patents for Guerbet

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986-003 Sep 21, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986-002 Sep 21, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986-006 Sep 21, 2022 RX Yes Yes ⤷  Start Trial ⤷  Start Trial
Guerbet DOTAREM gadoterate meglumine SOLUTION;INTRAVENOUS 204781-004 Mar 20, 2013 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986-007 Sep 21, 2022 RX Yes Yes 8,114,863 ⤷  Start Trial Y ⤷  Start Trial
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986-007 Sep 21, 2022 RX Yes Yes 10,973,934 ⤷  Start Trial Y ⤷  Start Trial
Guerbet HEXABRIX ioxaglate meglumine; ioxaglate sodium INJECTABLE;INJECTION 018905-002 Jul 26, 1985 DISCN No No ⤷  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

Expired US Patents for Guerbet

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Guerbet HEXABRIX ioxaglate meglumine; ioxaglate sodium INJECTABLE;INJECTION 018905-002 Jul 26, 1985 4,014,986 ⤷  Start Trial
Guerbet OXILAN-350 ioxilan INJECTABLE;INJECTION 020316-002 Dec 21, 1995 4,954,348 ⤷  Start Trial
Guerbet HEXABRIX ioxaglate meglumine; ioxaglate sodium INJECTABLE;INJECTION 018905-002 Jul 26, 1985 4,065,553 ⤷  Start Trial
Guerbet OXILAN-300 ioxilan INJECTABLE;INJECTION 020316-001 Dec 21, 1995 4,954,348 ⤷  Start Trial
Guerbet HEXABRIX ioxaglate meglumine; ioxaglate sodium INJECTABLE;INJECTION 018905-002 Jul 26, 1985 4,094,966 ⤷  Start Trial
Guerbet HEXABRIX ioxaglate meglumine; ioxaglate sodium INJECTABLE;INJECTION 018905-002 Jul 26, 1985 4,065,554 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for Guerbet Drugs

Country Patent Number Estimated Expiration
European Patent Office 4491199 ⤷  Start Trial
China 103224495 ⤷  Start Trial
Chile 2021001868 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2020148436 ⤷  Start Trial
European Patent Office 3770160 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2020030618 ⤷  Start Trial
South Korea 20250079243 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Guerbet Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1931673 24C1006 France ⤷  Start Trial PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 20231208
1931673 301259 Netherlands ⤷  Start Trial PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 20231208
1931673 2490004-5 Sweden ⤷  Start Trial PRODUCT NAME: GADOPICLENOL; REG. NO/DATE: EU/1/23/1772 20231208
1931673 SPC/GB24/007 United Kingdom ⤷  Start Trial PRODUCT NAME: GADOPICLENOL; REGISTERED: UK EU/1/23/1772(FOR NI) 20231208; UK FURTHER MAS ON IPSUM 20231208
1931673 C202430008 Spain ⤷  Start Trial PRODUCT NAME: GADOPICLENOL; NATIONAL AUTHORISATION NUMBER: EU/1/23/1772; DATE OF AUTHORISATION: 20231207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1772; DATE OF FIRST AUTHORISATION IN EEA: 20231207
1931673 2024C/510 Belgium ⤷  Start Trial PRODUCT NAME: GADOPICLENOL; AUTHORISATION NUMBER AND DATE: EU/1/23/1772 20231208
1931673 813 Finland ⤷  Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Guerbet – Market Position, Strengths & Strategic Insights

Last updated: December 26, 2025


Executive Summary

Guerbet, a French multinational specializing in contrast agents for medical imaging, has secured a robust position within the diagnostic imaging pharmaceutical sector. With a focus on contrast media utilized in MRI, CT scans, and X-ray procedures, Guerbet’s strategic investments in innovation, regulatory navigation, and geographic expansion bolster its competitive edge. This analysis evaluates Guerbet’s market standing, core strengths, competitive landscape, and strategic outlook to facilitate informed decision-making for industry stakeholders.


Market Overview and Guerbet’s Position

Global Contrast Media Market Overview

  • Market Size (2022): Estimated at USD 4.8 billion, with projections to reach USD 6.5 billion by 2028, at a CAGR of approximately 6.2% (source: MarketsandMarkets).
  • Key Segments:
    • MRI contrast agents (~45%)
    • CT contrast agents (~42%)
    • X-ray contrast media (~13%)
  • Geographic Breakdown:
    • North America: Largest market share (~40%)
    • Europe: ~30%
    • Asia-Pacific: Rapid growth (~20%), driven by increased healthcare infrastructure
    • Rest of the world (~10%)

Guerbet’s Market Footprint

  • Revenue (2022): Estimated at EUR 400 million (~USD 440 million)
  • Core Products:
    • Lipiodol (iodinated oil for embolization)
    • Cercure (Gadolinium-based MRI contrast)
    • Optiray (Iodinated contrast media)
  • Key Markets:
    • Europe: ~50%
    • North America: ~30%
    • Asia-Pacific and emerging markets: ~20%
  • Market Strategy: Focus on innovation, expanding product pipeline, and strategic acquisitions (e.g., acquisition of Agfa HealthCare’s contrast media assets in 2021).

Guerbet's Strengths in the Competitive Landscape

1. Focused Product Portfolio in High-Growth Segments

Product Category Major Products Market Relevance
MRI Contrast Agents Cercure, Dotarem Increasing MRI utilization globally
CT Contrast Agents Optiray, Telebrix Dominance in iodinated contrast media
Specialized Agents Lipiodol, ClearShot (interventional), Lipiodol Ultra-Fluid Niche segments, embolization, and lymphography

Implication: Guerbet’s diversified yet focused product portfolio enhances resilience across different imaging modalities and markets.

2. Emphasis on Innovation and R&D

  • R&D expenses: Approx. EUR 50 million annually (~12.5% of revenues)
  • Recent launches: Gadavist (Gadolinium-based MRI contrast)—approved in key markets and positioned as a safer alternative amid concerns regarding gadolinium deposition.
  • Pipeline products: Next-generation contrast agents with improved safety profiles and imaging efficacy.

3. Regulatory Expertise and Global Presence

  • Regulatory Approvals: Approvals in major markets (FDA, EMA, PMDA)
  • Patent Portfolio: Approximately 35 active patents globally
  • Regulatory Strategy: Proactive engagement with health authorities ensures faster approvals and market access.

4. Strategic Partnerships and Acquisitions

  • Key acquisition: Agfa HealthCare contrast assets (2021) for expansion into digital radiology integration
  • Licensing agreements with biotech firms to expand product pipeline

5. Strong Clinical and Industry Relationships

  • Collaborations with major hospitals, radiology societies, and key opinion leaders (KOLs)
  • Participation in international imaging conferences (RSNA, ECR) enhancing visibility

Competitive Landscape and Guerbet’s Position

Major Competitors

Company Market Share (2022 est.) Core Products Strengths
GE Healthcare 25-30% Omnipaque, Gadavist Global footprint, extensive R&D, broad product portfolio
Bayer (Siemens) 20-25% Multimodal contrast agents Strong R&D, integrated imaging solutions
Guerbet 8-10% Lipiodol, Gadavist, Optiray Focused niche expertise, innovation-driven, agile approach
Guerbet's Differentiators Niche focus, high R&D investment, strategic expansion

SWOT Analysis

Strengths Weaknesses
Focused portfolio in niche markets Smaller market share compared to giants
Robust R&D and innovation pipeline Limited presence in emerging markets
Regulatory expertise Dependence on certain key markets (Europe, N America)
Opportunities Threats
Growth in minimally invasive procedures Competition from biosimilars, generics
Expansion into emerging markets Regulatory hurdles in new regions
Development of safer, targeted contrast agents Pricing pressures and patent expirations

Strategic Insights and Future Outlook

1. Innovation as a Key Differentiator

Guerbet’s ongoing R&D focusing on safer, high-contrast imaging agents positions it favorably amid safety concerns associated with gadolinium retention. The launch of Gadavist and related agents underscores this drive.

2. Geographic Expansion Strategies

  • Target high-growth markets in Asia-Pacific, Latin America, and the Middle East
  • Leverage partnerships with regional distributors and local regulatory agencies

3. Digital Transformation and Integration

  • Integrate contrast media solutions with digital health platforms (e.g., PACS, RIS)
  • Expand into the emerging “smart imaging” segment to offer tailored contrast solutions

4. Strategic M&A Activity

  • Pursue acquisitions to broaden pipeline and expand market share
  • Potential targets include niche biosimilar developers or regional contrast media firms

5. Regulatory Navigation and Compliance

  • Maintain agility to adapt to evolving safety standards, especially regarding gadolinium-based agents
  • Invest in real-world evidence generation to bolster approvals and market confidence

Comparative Summary Table: Guerbet vs. Major Competitors

Attribute Guerbet GE Healthcare Bayer (Siemens)
Market Share (Est.) 8-10% 25-30% 20-25%
Product Focus Niche contrast agents Broad portfolio Broad, multimodal
R&D Investment 12.5% of revenues (~EUR 50M) Significant (~EUR 400M/year) Significant (~EUR 300M/year)
Innovation Pace High High High
Geographic Footprint Europe, N. America, Asia-Pacific Global Global

FAQs

Q1: How does Guerbet differentiate itself from competitors like GE and Bayer?
A: Guerbet specializes in niche contrast media with a focus on safety, innovation, and tailored solutions for interventional procedures. Its agility allows rapid product development, especially for safety-enhanced gadolinium agents, positioning it as a trusted partner in high-growth, safety-conscious markets.

Q2: What are Guerbet’s primary growth drivers?
A: Expansion into emerging markets, continuous R&D in safer contrast agents, strategic acquisitions, and integrating digital imaging solutions.

Q3: How is Guerbet managing regulatory challenges globally?
A: Through proactive engagement with global regulatory agencies, maintaining a strong patent portfolio, and investing in clinical trials to demonstrate safety and efficacy.

Q4: What areas present the greatest risks for Guerbet?
A: Regulatory hurdles, patent expirations, intensifying competition, and potential pricing pressures, especially in commoditized contrast media segments.

Q5: What strategic moves should Guerbet consider to expand market share?
A: Leveraging alliances in emerging regions, accelerating pipeline development of next-generation agents, and exploring acquisitions of regional contrast media firms or related health tech entities.


Key Takeaways

  • Guerbet maintains a focused, innovation-driven position in the contrast media market, emphasizing safety and niche applications.
  • Its strategic investments in R&D and regulatory expertise underpin its resilience and growth potential.
  • Competition from global giants remains fierce, but Guerbet’s agility and targeted regional strategies position it favorably.
  • Expansion into emerging markets and digital integration will be crucial to its future success.
  • Continuous innovation, strategic acquisitions, and navigating regulatory landscapes will determine Guerbet’s ability to grow its market share and maintain differentiation.

References

  1. MarketsandMarkets. (2022). Contrast Media Market.
  2. Guerbet Annual Report 2022.
  3. Company press releases and SEC filings (2021–2023).
  4. RSNA and ECR Conference Material (2022–2023).
  5. Industry analysis reports (Frost & Sullivan, 2022).

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