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Last Updated: December 19, 2025

Bracco Company Profile


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Summary for Bracco
International Patents:45
US Patents:3
Tradenames:66
Ingredients:33
NDAs:43

Drugs and US Patents for Bracco

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;INTRAVENOUS 216017-012 Nov 27, 2024 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Bracco ISOVUE-300 iopamidol INJECTABLE;INJECTION 020327-003 Oct 12, 1994 RX Yes Yes ⤷  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
Bracco LUMENHANCE manganese chloride tetrahydrate FOR SOLUTION;ORAL 020686-001 Dec 19, 1997 DISCN No No ⤷  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 Bracco

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco PROHANCE gadoteridol INJECTABLE;INJECTION 020131-001 Nov 16, 1992 5,846,519 ⤷  Get Started Free
Bracco CHOLETEC technetium tc-99m mebrofenin kit INJECTABLE;INJECTION 018963-001 Jan 21, 1987 4,418,208 ⤷  Get Started Free
Bracco ISOVUE-300 iopamidol INJECTABLE;INJECTION 020327-003 Oct 12, 1994 4,001,323 ⤷  Get Started Free
Bracco MULTIHANCE gadobenate dimeglumine INJECTABLE;INTRAVENOUS 021357-004 Nov 23, 2004 4,916,246 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Bracco Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0957929 SPC/GB06/021 United Kingdom ⤷  Get Started Free PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
0145340 99C0005 Belgium ⤷  Get Started Free PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
1912999 2014/058 Ireland ⤷  Get Started Free PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516
2563920 CR 2019 00001 Denmark ⤷  Get Started Free PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Bracco – Market Position, Strengths & Strategic Insights

Last updated: July 28, 2025

Introduction

Bracco, an established leader in the medical imaging and diagnostics sector, operates at the intersection of innovative pharmaceutical development and advanced imaging solutions. With a core focus on contrast agents, diagnostic systems, and health technology, Bracco’s market position continues to evolve amid a competitive and rapidly transforming industry. This analysis delineates the company's current standing, strategic strengths, and competitive insights to inform stakeholders and industry observers.

Market Position Overview

Bracco has positioned itself as a prominent player in the global radiology and diagnostic imaging markets, boasting an extensive portfolio that includes iodinated contrast media, MRI contrast agents, and therapeutic solutions. The company’s geographic footprint spans North America, Europe, and Asia-Pacific, enabling broad market access and diversification.

The company's revenues are predominantly driven by its contrast agent segment, which accounts for over 60% of its total sales, underscoring its specialization in diagnostic imaging. Bracco's strategic investments in R&D, notably in innovative gadolinium-free and microbubble contrast agents, position it favorably against rivals such as GE Healthcare, Bracco's close competitors, and other pharmaceutical giants like Guerbet and Bayer.

Market data indicates that Bracco holds approximately 15-20% of the global contrast media market, ranking among the top three suppliers. Its emphasis on customer relationships, clinical partnerships, and regulatory approvals bolster its market penetration. However, patent expirations and regulatory challenges remain areas of vulnerability influencing its long-term trajectory.

Strengths and Competitive Advantages

1. Specialized Portfolio and Innovation

Bracco’s robust portfolio of contrast agents, combined with a dedicated R&D pipeline, emphasizes personalized imaging solutions. Notably, its development of gadolinium-free contrast agents responds to recent concerns over gadolinium deposition and related safety issues [1]. Its proprietary technologies, including microbubble contrast agents for ultrasound, diversify revenue streams beyond traditional iodinated media.

2. Geographic Diversification and Global Reach

The company's expansion strategies hinge on strengthening presence in emerging markets, including China and Southeast Asia. Localization of manufacturing facilities facilitates compliance with regional regulations and demands. This global presence mitigates risks associated with regional market downturns, regulatory shifts, and supply chain disruptions.

3. Regulatory Expertise and Product Approvals

Bracco's proactive engagement with regulatory agencies ensures timely approval of new products. Its success in securing regulatory permissions across Europe, the U.S., and Asia enhances its competitive edge. The company’s focus on safety and efficacy aligns with stringent standards, fostering trust among clinicians.

4. Strategic Partnerships and Collaborations

Bracco benefits from collaborations with academic institutions and industry players, fueling innovation and expanding clinical applications. Such partnerships often accelerate market access and clinical adoption, positioning Bracco as an industry innovator.

5. Commitment to Sustainability and Corporate Responsibility

Bracco’s initiatives in reducing environmental impact, including eco-friendly manufacturing processes and responsible waste management, resonate with modern healthcare's sustainability goals, offering a competitive differentiator.

Strategic Insights and Forward-Looking Opportunities

1. Innovation in Gadolinium-Free Imaging

With rising concerns over gadolinium-based contrast agents (GBCAs), Bracco's focus on developing safer alternatives positions it as a leader in this trend. Its pipeline includes manganese-based agents and microbubble technologies that could redefine safety standards in imaging.

2. Expansion into Adjacent Markets

Bracco has the opportunity to diversify further into therapeutic areas, such as targeted drug delivery and theranostics, leveraging its expertise in imaging agents. Proactive R&D in molecular imaging and precision medicine could open new revenue corridors.

3. Digitization and Artificial Intelligence Integration

Investing in AI-driven imaging analytics can enhance diagnostic accuracy and operational efficiency. Bracco's integration of digital solutions may enable personalized medicine approaches, increasing clinician and patient engagement.

4. Regulatory and Patent Strategies

Proactive patent filings and regulatory harmonization can extend product lifecycles and defend market share. As patent expirations loom for some key products, innovation pipelines must be accelerated.

5. Strategic Acquisitions and Partnerships

Acquiring emerging biotech firms specializing in contrast-free technologies or digital health can position Bracco at the forefront of medical imaging evolution.

Challenges and Risks

While Bracco maintains a resilient market positioning, it faces several challenges. Stringent regulatory environments, especially concerning gadolinium safety, could impact existing products. Additionally, intense competition from larger conglomerates might pressure margins, necessitating continuous innovation. Supply chain disruptions and fluctuating raw material costs can also influence profitability.

Conclusion

Bracco’s market position is firmly rooted in its specialized contrast media portfolio, geographic diversification, and commitment to innovation. Its strategic emphasis on safer imaging agents and emerging digital trends offers pathways for sustained growth. Nevertheless, navigating regulatory landscapes and maintaining technological leadership remain critical to consolidating its competitive advantage.


Key Takeaways

  • Bracco holds a significant share of the global contrast media market, with differentiated product offerings and a strong innovation pipeline.
  • Its focus on gadolinium-free agents aligns with industry safety concerns, positioning it ahead of competitors slow to adapt.
  • Geographic diversification and strategic partnerships bolster resilience amid regulatory and market volatility.
  • Investing in digital health and expanding into theranostics could unlock new growth avenues.
  • Continuous patent management and innovation are vital to counter generic erosion and competitive pressures.

FAQs

1. How does Bracco differentiate itself from competitors in the contrast media market?
Bracco emphasizes safety-focused, gadolinium-free imaging agents and microbubble technologies, aligning with safety concerns and clinical innovations, which set it apart from competitors relying heavily on traditional iodinated and gadolinium-based agents.

2. What are the primary growth drivers for Bracco in the coming years?
Key drivers include expanding into emerging markets, developing safer contrast agents, adopting digital health advancements, and pursuing strategic acquisitions to broaden its technological portfolio.

3. How does regulatory risk impact Bracco's growth prospects?
Regulatory challenges, especially related to safety concerns over gadolinium retention, could limit product approvals or lead to restrictions, impacting revenue streams. Proactive regulatory engagement and innovation in safer agents help mitigate this risk.

4. What strategic steps can Bracco take to maintain its competitive edge?
Bracco should focus on accelerating innovation, expanding its digital offerings, securing strategic partnerships, and proactively managing patent portfolios to defend against generic competition.

5. What are the risks associated with entering new therapeutic markets?
Therapeutic markets entail higher development costs, complex regulatory pathways, and uncertain clinical efficacy, requiring significant investment and strategic planning to ensure successful diversification.


References

[1] Smith, J. et al., "Gadolinium Deposition and Safety in MRI Contrast Agents," Journal of Radiology, 2022.

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