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Last Updated: December 19, 2025

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 216986-007 Sep 21, 2022 RX Yes Yes 11,590,246 ⤷  Get Started Free Y ⤷  Get Started Free
Guerbet LIPIODOL ethiodized oil OIL;INTRALYMPHATIC, INTRAUTERINE 009190-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986-006 Sep 21, 2022 RX Yes Yes 10,973,934 ⤷  Get Started Free Y ⤷  Get Started Free
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986-005 Sep 21, 2022 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986-001 Sep 21, 2022 RX Yes Yes 8,114,863 ⤷  Get Started Free Y ⤷  Get Started Free
Guerbet ELUCIREM gadopiclenol SOLUTION;INTRAVENOUS 216986-003 Sep 21, 2022 RX Yes Yes ⤷  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

Expired US Patents for Guerbet

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

Supplementary Protection Certificates for Guerbet Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1931673 2024C/510 Belgium ⤷  Get Started Free PRODUCT NAME: GADOPICLENOL; AUTHORISATION NUMBER AND DATE: EU/1/23/1772 20231208
1931673 813 Finland ⤷  Get Started Free
1931673 301259 Netherlands ⤷  Get Started Free PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 20231208
1931673 C20240003 Finland ⤷  Get Started Free PRODUCT NAME: ELATSESTRANT;REG NO/DATE: EU/1/23/1757 18.09.2023
1931673 2490004-5 Sweden ⤷  Get Started Free PRODUCT NAME: GADOPICLENOL; REG. NO/DATE: EU/1/23/1772 20231208
1931673 24C1006 France ⤷  Get Started Free PRODUCT NAME: GADOPICLENOL; REGISTRATION NO/DATE: EU/1/23/1772 20231208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Guerbet – Market Position, Strengths & Strategic Insights

Last updated: July 27, 2025

Introduction

Guerbet, a global leader in contrast agents and medical imaging solutions, operates within the competitive pharmaceutical landscape underpinning diagnostic imaging. Established in 1926 and headquartered in France, Guerbet specializes in contrast media for computed tomography (CT), magnetic resonance imaging (MRI), and ultrasound procedures. As precision medicine-driven diagnostics increasingly influence patient management, strategic positioning and innovation become crucial for Guerbet to sustain growth amid intense competition. This analysis assesses Guerbet's current market position, core strengths, challenges, and strategic trajectory within the pharmaceutical and medical imaging sectors.

Market Position of Guerbet in the Pharmaceutical Landscape

Guerbet holds a significant position in the global contrast media market, valued at approximately USD 3.2 billion in 2022 and anticipated to grow at a compound annual growth rate (CAGR) of 4.4% through 2028[1]. Its geographic footprint spans North America, Europe, Asia-Pacific, and emerging markets, providing diversified revenue streams. Guerbet's portfolio includes flagship contrast agents such as Dotarem (Gadolinium-based MRI contrast), Lipiodol (iodinated oil for chemoembolization), and Optiray (iodinated contrast for CT).

Despite fierce competition from global giants such as Bayer (with contrast agents like Multihance, Ultravist), GE Healthcare, and Bracco Imaging, Guerbet maintains a distinctive niche through its focus on innovative, safety-enhanced contrast media and a comprehensive clinical pipeline. Its strategic emphasis on reducing nephrogenic systemic fibrosis (NSF) risks associated with gadolinium-based contrasts and developing next-generation agents positions it favorably within regulatory and clinical adoption curves.

Strengths Driving Guerbet’s Competitive Edge

1. Specialized Focus on Diagnostic Imaging

Guerbet’s concentrated expertise in contrast media offers a competitive advantage by enabling the company to innovate rapidly within a niche segment. Its probiotic approach towards developing safer, more effective imaging solutions addresses unmet clinical needs, particularly in vulnerable patient populations such as those with impaired renal function or allergies.

2. Robust Product Portfolio and Innovation Pipeline

Guerbet's flagship products like Dotarem and Lipiodol are well-established, with high brand recognition. The firm actively invests in R&D, contributing to a pipeline that includes macrocyclic gadolinium agents with improved safety profiles and targeted contrast media. Recent acquisitions, such as the oncology imaging platform from Nexus Medical, bolster its product diversity and technological capabilities.

3. Strategic Alliances and Regulatory Approvals

Partnerships with university research centers and regulatory bodies facilitate accelerated approval pathways for new agents. For example, Guerbet’s expansion into non-contrast-enhanced imaging techniques complements its contrast agent portfolio, offering holistic diagnostic solutions.

4. Geographic Diversification and Localized Manufacturing

Guerbet’s extensive global footprint ensures exposure to high-growth emerging markets, reducing dependency on saturated regions. Local manufacturing facilities in Europe, Asia, and the Middle East streamline supply chains and optimize cost efficiency.

5. Commitment to Safety and Sustainability

Guerbet’s focus on developing environmentally conscious contrast agents reduces the ecological footprint of its products, aligning with global regulatory trends and corporate social responsibility expectations. Its efforts in reducing gadolinium deposition and addressing NSF concerns exemplify its innovation in safety.

Strategic Challenges and Areas for Improvement

1. Intense Competition and Market Saturation

Bayer’s dominant market share, coupled with GE Healthcare and Bracco's aggressive marketing, compounds Guerbet’s challenge to increase market penetration, especially in regions with entrenched brand loyalty. Differentiation thus hinges on innovation and clinical efficacy.

2. Regulatory Hurdles and Safety Concerns

Increased regulatory scrutiny over gadolinium retention and adverse events may pose hurdles for new contrast media approval. Rapidly evolving policies necessitate proactive compliance and scientific validation.

3. Limited Presence in Non-Contrast Imaging Modalities

While Guerbet invests in contrast media, its portfolio in emerging non-contrast imaging techniques like molecular imaging or AI-enabled diagnostics remains limited compared to competitors pivoting towards digital health integrations.

4. Price Competition and Reimbursement Dynamics

Pricing pressures from health systems and reimbursement policies impact profitability. Guerbet must maintain a balance between innovation investments and cost competitiveness.

5. Digital Transformation and Data Integration

The healthcare industry’s shift towards digital solutions presents an opportunity but also challenges Guerbet to adapt operationally and develop data-driven imaging solutions complementing contrast agents.

Strategic Insights for Future Growth

Innovation in Safer, Targeted Contrast Agents

Guerbet’s R&D focus on macrocyclic gadolinium chelates with lower kinetic stability issues and agents with enhanced renal safety can differentiate the company. Targeted, molecular contrast media for personalized diagnostics could be game-changers in precision medicine.

Expanding into AI and Digital Diagnostics

Investment in digital health platforms, AI-driven imaging analysis, and integration with electronic health records can enhance Guerbet’s value proposition. Strategic alliances with technology firms could accelerate this transition.

Market Penetration in Emerging Economies

Localized manufacturing and pricing strategies tailored to regional healthcare budgets can foster accelerated adoption in Asia-Pacific, Latin America, and Africa, unlocking greater revenue streams.

Portfolio Diversification Beyond Contrast Media

Venturing into complementary imaging sectors, such as molecular imaging agents or therapeutic pharmaceuticals, can mitigate market saturation risks and foster cross-platform synergies.

Sustainability and Regulatory Leadership

Proactively engaging with regulators and environmental agencies to set industry standards will reinforce Guerbet’s reputation as an innovation leader committed to safety and environmental stewardship.

Conclusion

Guerbet’s strategic positioning hinges on its core expertise in contrast media, innovation in safety-oriented products, and global expansion. While faced with intense competition and regulatory complexities, Guerbet’s focus on differentiation through advanced, targeted agents and digital integration aligns well with impending industry trends. Sustained investment in R&D, strategic collaborations, and expansion in high-growth markets will be essential to maintaining its competitive edge.


Key Takeaways

  • Guerbet maintains a strong niche in contrast media innovation, emphasizing safety and personalized diagnostics.
  • The company’s global footprint and strategic alliances support its growth trajectory amid competitive pressure.
  • Challenges include intense market competition, regulatory hurdles, and limited diversification outside contrast agents.
  • Future growth hinges on innovation in targeted contrast media, embracing digital health technologies, and expanding in emerging markets.
  • Proactive sustainability initiatives and regulatory engagement will enhance Guerbet’s market reputation and operational resilience.

FAQs

1. How does Guerbet differentiate itself from competitors like Bayer and GE Healthcare?
Guerbet emphasizes safety-enhanced, targeted contrast agents and invests heavily in R&D for next-generation imaging solutions, focusing on personalized and safer diagnostics, which differentiates it from larger, more diversified competitors.

2. What are Guerbet’s primary growth strategies?
The company aims to deepen innovation in contrast media, expand into emerging markets, adopt digital imaging technologies, and diversify its portfolio beyond traditional contrast agents.

3. How does regulatory scrutiny impact Guerbet’s product pipeline?
Stringent regulations on gadolinium-based contrasts, especially concerning retention and NSF risks, demand rigorous safety data and can delay product approvals. Guerbet’s proactive safety and environmental initiatives aim to mitigate this impact.

4. What role does digital transformation play in Guerbet’s future?
Digital health integration, AI-powered imaging analysis, and data analytics are pivotal in expanding Guerbet’s product offerings and improving diagnostic accuracy, aligning with industry trends toward precision medicine.

5. Can Guerbet sustain its competitive advantage in a mature market?
Yes, through continuous innovation, strategic collaborations, market expansion, and embracing digital health, Guerbet can maintain its niche and capitalize on emerging diagnostic innovations.


References

[1] Market Data Forecast. "Contrast Media Market Size & Trends." 2022.

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