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Last Updated: July 29, 2025

Sanofi Aventis Us Company Profile


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Summary for Sanofi Aventis Us
International Patents:218
US Patents:10
Tradenames:95
Ingredients:84
NDAs:119

Drugs and US Patents for Sanofi Aventis Us

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Sanofi Aventis Us BRONKOMETER isoetharine mesylate AEROSOL, METERED;INHALATION 012339-007 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 AB RX Yes Yes 8,602,215 ⤷  Try for Free ⤷  Try for Free
Sanofi Aventis Us NOVAFED pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 017603-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Sanofi Aventis Us PRESAMINE imipramine hydrochloride TABLET;ORAL 011836-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Sanofi Aventis Us SLO-BID theophylline CAPSULE, EXTENDED RELEASE;ORAL 089539-001 May 10, 1989 DISCN No No ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Expired US Patents for Sanofi Aventis Us

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-002 May 1, 1984 3,426,067 ⤷  Try for Free
Sanofi Aventis Us LASIX furosemide INJECTABLE;INJECTION 016363-001 Approved Prior to Jan 1, 1982 4,324,779 ⤷  Try for Free
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-007 Jun 2, 2000 4,486,420 ⤷  Try for Free
Sanofi Aventis Us SKELID tiludronate disodium TABLET;ORAL 020707-001 Mar 7, 1997 4,876,248 ⤷  Try for Free
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 5,714,512*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries
Paragraph IV (Patent) Challenges for SANOFI AVENTIS US drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 300 mg ➤ Subscribe 2009-03-04
➤ 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 Tablets 400 mg ➤ Subscribe 2013-07-01
➤ 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

Supplementary Protection Certificates for Sanofi Aventis Us Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0281459 35/1998 Austria ⤷  Try for Free PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
0281459 98C0036 France ⤷  Try for Free PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
1667986 C 2013 017 Romania ⤷  Try for Free PRODUCT NAME: SOLVAT ACETONIC DE CABAZITAXEL; NATIONAL AUTHORISATION NUMBER: EU/1/11/676/001; DATE OF NATIONAL AUTHORISATION: 20110317; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/676/001; DATE OF FIRST AUTHORISATION IN EEA: 20110317
3300601 C202230030 Spain ⤷  Try for Free PRODUCT NAME: COMBINACION DE DAUNORUBICINA Y CITARABINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1308; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1308; DATE OF FIRST AUTHORISATION IN EEA: 20180823
0281459 C990002 Netherlands ⤷  Try for Free PRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: SANOFI AVENTIS US – Market Position, Strengths & Strategic Insights

Last updated: July 28, 2025

Introduction

Sanofi Aventis US stands as a prominent player in the highly competitive pharmaceutical sector, with a focus on innovative therapeutics, vaccines, and consumer healthcare. As of 2023, the company maintains a robust market presence driven by strategic product portfolios, extensive R&D, and targeted acquisitions. Understanding Sanofi’s market position, core strengths, and strategic initiatives provides vital insights for stakeholders navigating the dynamic pharmaceutical landscape.

Market Position in the US

Sanofi’s US operations rank among the top-tier pharmaceutical companies, particularly excelling in specialty care and immunology segments. The company’s footprint extends across various therapeutic areas, including diabetes, oncology, rare diseases, and vaccines.

Sales Performance and Market Share

In 2022, Sanofi generated approximately $11 billion in US sales, positioning it within the top 10 pharmaceutical firms domestically, per pharmaceutical industry reports [1]. Notably, its flagship products such as Dupixent (dupilumab) and Libtayo (cemiplimab) have bolstered its market share. Dupixent, used in atopic dermatitis, asthma, and other allergic conditions, contributed significantly to revenue growth — with US sales surpassing $4 billion annually [2].

Therapeutic Area Strengths

  • Immunology & Dermatology: Dupixent's success underscores Sanofi’s leadership in biologics, capturing a significant share of the US eczema and asthma markets.
  • Vaccines: Sanofi Pasteur’s vaccine portfolio remains influential, especially in flu and emerging infectious diseases, commanding a solid US market presence.
  • Rare Diseases & Oncology: Strategic acquisitions, such as the 2022 purchase of Translate Bio, enhance Sanofi’s pipeline in mRNA vaccines and targeted therapies.

Competitive Positioning

Sanofi faces formidable competition from global giants like Pfizer, Novartis, and Roche. Its differentiated focus on biologics and vaccines segments, combined with niche specialty drugs, positions it uniquely. However, intense R&D investments and patent expiries generate market pressures necessitating continual innovation.

Strengths of Sanofi Aventis US

1. Diversified Product Portfolio

Sanofi’s breadth across vaccines, specialty care, and consumer health ensures resilience amid market fluctuations. The flagship biologic Dupixent exemplifies this diversification, propelling revenue growth and cementing Sanofi’s leadership in immunology.

2. Robust R&D Pipeline

The company invests approximately 20% of its revenues in R&D, emphasizing biologic innovations and personalized medicine [3]. Current pipelines include gene therapies, monoclonal antibodies, and mRNA vaccine candidates, positioning Sanofi at the forefront of innovation.

3. Strategic Collaborations and Acquisitions

Recent partnerships have expanded Sanofi’s technological capabilities. Notably, its collaboration with Translate Bio aims to develop mRNA vaccines and therapies, aligning with cutting-edge trends in vaccine technology. Such alliances broaden its pipeline and accelerate go-to-market strategies.

4. Market Share in Emerging Therapeutic Areas

Sanofi’s focus on rare disease treatments, notably with Syringe (sodium phenylbutyrate) and other orphan drugs, grants it solid footholds in underserved markets with high growth potential.

5. Commitment to Digital Transformation

Sanofi leverages digital health tools for patient engagement, clinical trials, and supply chain optimization, improving operational efficiency and customer experience.

Strategic Insights

Focus on Innovation and Personalized Medicine

Sanofi’s investments in biologics and gene therapies align with industry trends favoring personalized treatment modalities. Future growth hinges on advancing its mRNA platforms, especially post-COVID-19 vaccine development.

Expansion in Specialty and Rare Diseases

Targeting niche markets with high unmet needs offers revenue stability and premium pricing opportunities. Sanofi’s expanding rare disease portfolio aligns well with this strategy.

Vaccine Industry Leadership

With the recent acquisition of Translate Bio, Sanofi intensifies its role in mRNA platforms, especially pertinent amidst the COVID-19 pandemic era. Strengthening vaccine innovation secures its competitive advantage.

Navigating Patent Expiries and Biosimilar Competition

Patented biologics face biosimilar threats post-expiry. Sanofi’s focus on next-generation biologics and diversified pipelines mitigates these risks and maintains revenue streams.

Operational Efficiency and Cost Management

Continued digital investments and process optimization will be crucial to sustain margin expansion amid R&D and marketing expenditures.

Challenges and Considerations

  • Regulatory Environment: Stringent US FDA approval pathways and pricing regulations demand agile compliance strategies.
  • Market Saturation: Leading biologic products face biosimilar competition, impacting revenue forecasts.
  • Pipeline Risks: Uncertainties in drug development outcomes necessitate diversified R&D investments.
  • Global Supply Chain Disruptions: Pandemic-related disruptions could impact manufacturing and distribution.

Future Outlook and Strategic Recommendations

Sanofi’s trajectory indicates sustained growth through innovation in biologics, vaccines, and targeted therapies. To capitalize on emerging opportunities, the company should:

  • Accelerate mRNA and gene therapy development, leveraging recent platform acquisitions.
  • Continue strategic collaborations focusing on personalized medicine.
  • Strengthen its position in the rare disease segment by expanding its pipeline and market access.
  • Emphasize digital health initiatives to streamline operations and enhance patient engagement.
  • Monitor regulatory developments to adapt swiftly and preserve market access.

Key Takeaways

  • Sanofi Aventis US’s diversified portfolio, particularly strong in immunology and vaccines, sustains its competitive edge.
  • Strategic investments in biologics, mRNA, and gene therapies position Sanofi for future growth amid evolving industry dynamics.
  • The company’s focus on rare diseases and personalized medicine aligns with market trends favoring high-margin, niche therapeutics.
  • Navigating biosimilar threats and regulatory hurdles remains critical, requiring ongoing pipeline innovation and operational agility.
  • Digital transformation initiatives are integral to Sanofi’s strategy to improve efficiency, patient outcomes, and competitive positioning.

FAQs

1. How does Sanofi’s market share in the US compare to its competitors?
Sanofi ranks among the top 10 US pharmaceutical companies, with specific strength in biologics and vaccines. Its flagship products, like Dupixent, have secured considerable market share, but competitors such as Pfizer and Novartis have larger territories in certain segments.

2. What are Sanofi’s main growth drivers in the US?
Key growth drivers include the continued success of Dupixent, expansion of the rare disease portfolio, mRNA vaccine development through recent acquisitions, and strategic collaborations in personalized medicine.

3. How does Sanofi mitigate biosimilar competition?
Sanofi invests in next-generation biologics, diversifies its pipeline, and accelerates personalized medicine initiatives to stay ahead of biosimilar entrants. Its focus on innovation and high-cost specialty drugs provides barriers to generic competition.

4. What strategic moves are shaping Sanofi’s future in the US?
Major strategic moves include strengthening its biologics and mRNA platforms, acquiring biotech startups, and expanding its portfolio in orphan and rare diseases to capitalize on emerging market trends.

5. What challenges does Sanofi face in maintaining its US market position?
Challenges include regulatory compliance, biosimilar threats, high R&D costs, and potential market saturation. Addressing these requires continuous innovation, operational efficiency, and effective market access strategies.


Sources

  1. IQVIA, 2022 Pharmaceutical Trends Report.
  2. Sanofi Annual Report 2022.
  3. Sanofi R&D Investment Data, 2022.
  4. Reuters, Sanofi’s Vaccine Pipeline and Collaborations.
  5. Statista, US Pharmaceutical Market Share Figures, 2022.

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