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Last Updated: December 11, 2025

Sanofi Company Profile


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Summary for Sanofi

Drugs and US Patents for Sanofi

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us SLO-BID theophylline CAPSULE, EXTENDED RELEASE;ORAL 087894-001 Jan 31, 1985 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us SLO-PHYLLIN theophylline SYRUP;ORAL 085187-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us METATENSIN #2 reserpine; trichlormethiazide TABLET;ORAL 012972-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us DECAPRYN doxylamine succinate TABLET;ORAL 006412-014 Approved Prior to Jan 1, 1982 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 Sanofi

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-001 Apr 6, 2000 7,148,211 ⤷  Get Started Free
Sanofi HECTOROL doxercalciferol INJECTABLE;INJECTION 021027-001 Apr 6, 2000 5,707,980 ⤷  Get Started Free
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-003 Sep 10, 1998 5,679,709 ⤷  Get Started Free
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 5,714,512*PED ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SANOFI drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Powder for Oral Suspension 0.8 g/packet and 2.4 g/packet ➤ Subscribe 2009-12-30
➤ Subscribe Injection 5 mg/mL, 10 mL and 20 mL vials ➤ Subscribe 2007-02-09
➤ Subscribe Injection 200 mg/40 mL ➤ Subscribe 2007-07-16
➤ Subscribe Injection 100 mg/mL, 3 mL vials ➤ Subscribe 2006-12-07
➤ Subscribe Tablets 150 mg/12.5 mg and 300 mg/12.5 mg ➤ Subscribe 2004-11-10
➤ Subscribe Tablets 75 mg, 150 mg and 300 mg ➤ Subscribe 2004-05-25
➤ Subscribe Capsules 0.5 mcg and 2.5 mcg ➤ Subscribe 2009-03-25
➤ Subscribe Tablets 300 mg ➤ Subscribe 2009-03-04
➤ Subscribe Capsules 1 mcg ➤ Subscribe 2010-02-12
➤ Subscribe Tablets 800 mg ➤ Subscribe 2008-12-04
➤ Subscribe Injection 40 mg/mL, 0.5 mL and 2 mL vials ➤ Subscribe 2009-06-30
➤ Subscribe For Injection 50 mg/vial and 100 mg/vial ➤ Subscribe 2007-02-09
➤ Subscribe Injection 5 mg/mL, 40 mL vial ➤ Subscribe 2011-03-23
➤ Subscribe Tablets 7 mg and 14 mg ➤ Subscribe 2016-09-12
➤ Subscribe Tablets 300 mg/25 mg ➤ Subscribe 2006-06-06
➤ Subscribe Capsules 0.4 mg ➤ Subscribe 2004-12-20
➤ Subscribe Tablets 400 mg ➤ Subscribe 2013-07-01
➤ Subscribe Injection 2 mcg/mL, 2 mL ampules ➤ Subscribe 2007-10-15
➤ Subscribe Injection 2 mcg/mL, 1 mL in 2 mL vial ➤ Subscribe 2011-12-28

Supplementary Protection Certificates for Sanofi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0186405 SPC/GB00/021 United Kingdom ⤷  Get Started Free PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
1744764 122018000134 Germany ⤷  Get Started Free PRODUCT NAME: ZUSAMMENSETZUNG AUS DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 20180823
3300601 301185 Netherlands ⤷  Get Started Free PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
1744764 2018/042 Ireland ⤷  Get Started Free PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180823
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Pharmaceutical Competitive Landscape Analysis: SANOFI – Market Position, Strengths & Strategic Insights

Last updated: October 15, 2025


Introduction

Sanofi, a global pharmaceutical powerhouse headquartered in Paris, France, ranks among the top-tier players in the healthcare industry. With an extensive portfolio spanning vaccines, specialty care, and consumer healthcare, Sanofi's strategic moves and market positioning influence the competitive dynamics of the pharmaceutical sector. This analysis examines Sanofi’s current market position, core strengths, competitive challenges, and strategic initiatives shaping its future trajectory within the fiercely competitive pharmaceutical landscape.


Market Position of Sanofi

Global Footprint and Financial Performance

Sanofi ranks consistently among the world's leading pharmaceutical companies, with revenues exceeding €36 billion in 2022[1]. The company's geographic footprint spans over 100 countries, with significant market shares in Europe, North America, and emerging markets in Asia and Latin America.

Product Portfolio and Therapeutic Focus

Sanofi operates across multiple therapeutic areas, including:

  • Vaccines (Sanofi Pasteur): A global leader in vaccine development, with notable products like Dengvaxia and vaccines for influenza, polio, and hepatitis.
  • Specialty Care: Focused on rare diseases, oncology, and immunology with products like Dupixent (duplimab) and Aubagio (teriflunomide).
  • General Medicines: Includes biosimilars and established therapies for diabetes and cardiovascular diseases.

Market Positioning in Key Segments

  • Vaccines: Sanofi Pasteur’s vaccine division is the second-largest producer globally, competing closely with GlaxoSmithKline (GSK) and Pfizer.
  • Immunology and Rare Diseases: With Dupixent’s blockbuster status, Sanofi has strengthened its position in immunology. Its biosimilars portfolio, now expanding through strategic acquisitions, enhances its stance in cost-effective therapeutics.
  • Oncology: Although not yet a market leader, Sanofi's investments in oncology-focused collaborations and R&D place it in a competitive position.

Competitive Standing

Sanofi's global revenue rank positions it within the top five pharmaceutical firms, often trailing behind Johnson & Johnson, Pfizer, and Roche. However, Sanofi’s strategic emphasis on vaccines and specialty care provides robust growth avenues, particularly amidst the pandemic-driven vaccine demand surge.


Core Strengths of Sanofi

1. Leading Vaccine Franchise

Sanofi Pasteur’s vaccine portfolio is a significant competitive advantage, particularly in emerging markets where vaccine demand proliferates. The company's pioneering contributions to global vaccination initiatives bolster its reputation in public health sectors.

2. Focused Specialty Care Pipeline

Sanofi’s investments in immunology, rare diseases, and oncology yield high-margin products including Dupixent, which achieved over €7 billion in sales in 2022[2]. This focus on specialty medicines aligns with industry trends favoring high-value, chronic-disease therapies.

3. Robust R&D Capabilities

Sanofi’s R&D expenditure, approximately €2.9 billion annually[3], fuels innovation in vaccines, biologics, and small-molecule drugs. Collaborations with biotech firms (e.g., Regeneron) enhance its pipeline robustness.

4. Strategic Acquisitions and Alliances

Acquiring companies like Bioverativ (hemophilia therapeutics) and forming partnerships, especially with Regeneron in immunology and ophthalmology, have accelerated Sanofi’s access to novel platforms and diversified risk.

5. Global Manufacturing and Distribution Network

Sanofi’s extensive manufacturing infrastructure ensures supply chain resilience. Its presence in high-growth regions offers access to rapidly expanding markets.


Strategic Challenges and Competitive Threats

1. Intense Competition from Big Pharma

Sanofi faces stiff competition from Pfizer, Johnson & Johnson, Roche, and GSK. These rivals possess advanced R&D pipelines, extensive marketing channels, and diversified portfolios that challenge Sanofi’s market share.

2. Patent Expirations and Biosimilar Competition

The expiry of patents on key products exposes Sanofi to biosimilar competition, eroding revenue streams and pressuring profit margins.

3. Regulatory and Public Perception Risks

Vaccine controversies, such as the Dengvaxia safety issues, impact public trust. Additionally, regulatory delays and compliance costs remain vital challenges.

4. Innovation and Digital Transformation Gaps

Sanofi's digital transformation initiatives are ongoing; lagging in personalized medicine and digital health integration could hamper future competitiveness.

5. Emerging Market Risks

While offering growth potential, markets in Latin America, Asia, and Africa are subject to political, economic, and logistical risks, impacting sales and supply chain stability.


Strategic Initiatives and Future Outlook

1. Focused Investment in Molecular & Biotech R&D

Sanofi is ramping investments into gene therapies, mRNA platforms, and personalized medicine. The company’s recent partnership with BioNTech for mRNA vaccine development exemplifies this focus[4].

2. Expansion of Specialty Medicine Portfolio

The firm aims to double its specialty care revenue by 2025 through organic and acquisition-driven growth, emphasizing immunology, rare diseases, and oncology.

3. Vaccine Innovation and Pandemic Preparedness

Sanofi plans to leverage its vaccine expertise by investing in next-generation vaccines and establishing manufacturing hubs to ensure rapid response capabilities in future pandemics.

4. Digital and Data-Driven Transformation

Sanofi’s strategic pivot toward digital health emphasizes real-world data integration, patient-centric approaches, and smarter clinical trials.

5. Sustainability and Access Initiatives

Committed to improving global health equity, Sanofi prioritizes affordable access in emerging markets, aligning with global health agendas and regulatory pressures.


Conclusion

Sanofi's strategic focus on vaccines, specialty therapeutics, and innovative R&D positions it favorably within a competitive landscape marked by rapid technological advances and global health challenges. While vulnerabilities remain around patent expirations and regulatory risks, Sanofi’s proactive investments and strategic partnerships aim to safeguard its market share and unlock future growth avenues.


Key Takeaways

  • Sanofi is a leading player in vaccines and specialty care, with a diversified, innovation-driven portfolio.
  • Its strategic acquisitions and alliances significantly enhance its pipeline and market reach.
  • Challenges include patent expirations, biosimilar competition, and geopolitical risks in emerging markets.
  • The company's ongoing digital transformation and focus on personalized medicine are vital for future competitiveness.
  • Resilient manufacturing, global access initiatives, and pandemic preparedness will underpin Sanofi’s long-term growth.

FAQs

Q1: How does Sanofi compare to its competitors in vaccine production?
A: Sanofi Pasteur is the second-largest vaccine manufacturer globally, competing closely with GSK and Pfizer. Its strategic investments, especially in emerging markets, bolster its position.

Q2: What are Sanofi’s most lucrative products currently?
A: Dupixent leads specialty care revenues, surpassing €7 billion in 2022, followed by vaccines and biosimilars.

Q3: How is Sanofi addressing biosimilar competition?
A: Through strategic acquisitions, pipeline expansion in biologics, and competitive pricing strategies to maintain market share.

Q4: What growth areas is Sanofi prioritizing?
A4: Immunology, rare diseases, oncology, and next-generation vaccines.

Q5: What are the main risks facing Sanofi in the coming years?
A: Patent expirations, biosimilars, regulatory challenges, digital transformation lag, and geopolitical risks in emerging markets.


Sources

  1. Sanofi Annual Report 2022.
  2. Sanofi Investor Presentation Q4 2022.
  3. Sanofi R&D Expenditure Report 2022.
  4. Regeneron and Sanofi Announce mRNA Vaccine Collaboration, 2022.

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