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Last Updated: December 15, 2025

Sanofi Aventis Us Company Profile


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Summary for Sanofi Aventis Us
International Patents:219
US Patents:10
Tradenames:95
Ingredients:85
NDAs:119

Drugs and US Patents for Sanofi Aventis Us

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 TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us RIFADIN rifampin INJECTABLE;INJECTION 050627-001 May 25, 1989 AP RX Yes Yes ⤷  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 AVAPRO irbesartan TABLET;ORAL 020757-001 Sep 30, 1997 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes 6,794,410*PED ⤷  Get Started Free Y ⤷  Get Started Free
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No 9,186,346*PED ⤷  Get Started Free Y ⤷  Get Started Free
Sanofi Aventis Us SLO-PHYLLIN theophylline CAPSULE, EXTENDED RELEASE;ORAL 085203-001 May 24, 1982 DISCN Yes 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 Aventis Us

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-003 May 1, 1984 3,507,961 ⤷  Get Started Free
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-002 May 1, 1984 3,426,067 ⤷  Get Started Free
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-006 Jun 2, 2000 5,389,618 ⤷  Get Started Free
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 6,387,946 ⤷  Get Started Free
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-001 Sep 10, 1998 4,351,841 ⤷  Get Started Free
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021759-001 Jan 31, 2005 5,716,988*PED ⤷  Get Started Free
Sanofi Aventis Us PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 020343-003 Aug 9, 1994 4,313,951*PED ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SANOFI AVENTIS US drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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 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

International Patents for Sanofi Aventis Us Drugs

Country Patent Number Estimated Expiration
Japan 2013505213 ⤷  Get Started Free
Japan 5566466 ⤷  Get Started Free
European Patent Office 3195862 ⤷  Get Started Free
South Korea 101123588 ⤷  Get Started Free
European Patent Office 1935416 ⤷  Get Started Free
Taiwan I468190 ⤷  Get Started Free
Cyprus 1110446 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Sanofi Aventis Us Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0454511 SPC/GB98/037 United Kingdom ⤷  Get Started Free PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE) (GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS.; REGISTERED: CH 54 250.02 19970815; UK EU/1/97/046/001 19970827; UK EU/1/97/046/002 19970827; UK EU/1/97/046/003 19970827; UK EU/1/97/046/004 19970827; UK EU/1/97/046/005 19970827; UK EU/1/97/046/006 19970827; UK EU/1/97/046/007 19970827; UK EU/1/97/046/008 19970827; UK EU/1/97/046/009 19970827
1499331 13C0055 France ⤷  Get Started Free PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
2380576 SPC/GB20/050 United Kingdom ⤷  Get Started Free PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526
2768484 301016 Netherlands ⤷  Get Started Free PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: NOT AVAILABLE
1381356 8/2014 Austria ⤷  Get Started Free PRODUCT NAME: TERIFLUNOMID, SEINE STEREOISOMERE AND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/838 20130826
2673237 LUC00111 Luxembourg ⤷  Get Started Free PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326
0100718 96C0006 Belgium ⤷  Get Started Free PRODUCT NAME: TILUDRONATE DISODIQUE EXPRIME EN ACIDE TILUDRONIQUE; NAT. REGISTRATION NO/DATE: 201 IS 106 F 3 19950907; FIRST REGISTRATION: LI 53014 19950220
>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: SANOFI AVENTIS US – Market Position, Strengths & Strategic Insights

Last updated: October 15, 2025

Introduction

Sanofi Aventis US stands as a dominant player within the United States pharmaceutical industry, leveraging a diverse portfolio of prescription medicines, vaccines, and specialty care products. This analysis explores Sanofi’s market positioning, core strengths, strategic initiatives, and future outlook amidst an evolving competitive landscape characterized by innovation, regulatory challenges, and shifting consumer preferences.

Market Position of Sanofi Aventis US

Sanofi has established a significant foothold across several therapeutic areas, notably in diabetes, vaccines, oncology, and rare diseases. In the US, the company's strategic focus on high-impact markets has translated into notable market share, particularly through its flagship products such as Lantus for diabetes management and Dengvaxia vaccines. According to IQVIA data, Sanofi commands an approximate 5-7% share within the US prescription drug market, positioning it within the top Tier 10 pharmaceutical companies (IQVIA, 2022).

Sanofi's presence is reinforced via strategic collaborations and acquisitions, fueling its pipeline and expanding its commercial reach. Notably, its recent partnership with BioNTech to develop mRNA vaccines exemplifies proactive adaptation to emerging biotech trends, particularly highlighted during the COVID-19 pandemic.

Core Strengths

1. Robust Portfolio in Vaccines and Specialty Care

Sanofi’s vaccine segment, driven by flagship offerings like Flublok and Dengvaxia, provides a competitive edge in immunization markets. The company's vaccine revenue grew by approximately 10% CAGR over five years, highlighting resilience and innovation capacity (Sanofi Annual Report, 2022). Additionally, Sanofi’s focus on rare diseases and biosimilars addresses unmet medical needs, which often command premium pricing and foster patient loyalty.

2. Strong R&D Pipeline and Innovation

Sanofi invests roughly 15% of its revenues into R&D, aiming to accelerate the development of next-generation therapies. Its pipeline features promising candidates in oncology (e.g., SAR442257, a CD73 inhibitor) and immunology. The acquisition of Principia Biopharma in 2021, notably for multiple sclerosis (MS) therapies, exemplifies strategic inorganic growth, bolstering its specialty drug portfolio.

3. Strategic Collaborations and Alliances

Partnerships with biotech firms and academic institutions propel Sanofi's innovation agenda. Its alliance with BioNTech for mRNA vaccine development underscores its agility in responding to global health crises, ensuring market relevance and expanding its pipeline.

4. Global Supply Chain and Manufacturing Excellence

Sanofi’s extensive manufacturing footprint facilitates reliable supply chains, essential amid global disruptions experienced during the pandemic. Its US-based manufacturing facilities have undergone modernization, ensuring quality compliance and cost efficiencies.

5. Commitment to Sustainability and Patient-Centric Initiatives

Sanofi’s corporate sustainability efforts, including affordable access programs and digital health initiatives, strengthen its brand reputation and stakeholder trust in the US market.

Strategic Insights

1. Emphasis on mRNA Technology and Vaccine Innovation

Building upon its COVID-19 vaccine success, Sanofi aims to expand its vaccine portfolio using mRNA technology, aiming to compete with Moderna and Pfizer. The company’s research on influenza and personalized vaccines indicates strategic diversification aligned with public health needs.

2. Focused Expansion in Oncology and Rare Diseases

Sanofi’s pipeline prioritizes targeted therapies for cancer and rare genetic disorders. Its acquisition of BioPharma assets positions it to capitalize on personalized medicine's growth trajectory, aiming to secure early-market penetration.

3. Digital Transformation and Data-Driven Approaches

Sanofi is investing in digital health tools and analytics to enhance clinical trials, patient engagement, and pharmacovigilance. Initiatives include deploying AI-driven drug discovery platforms and telehealth services, fostering operational efficiencies.

4. Navigating Market Access and Regulatory Complexities

Sanofi’s strategic positioning involves proactive engagement with US FDA regulators to accelerate approvals, especially for innovative therapies. Its pricing strategies emphasize value-based models that balance patient affordability with profitability.

5. Competitive Response to Biosimilar Adoption

As biosimilars penetrating the US market threaten branded biologics, Sanofi is advancing biosimilar development to maintain share in high-revenue segments like insulin and monoclonal antibodies, vital for long-term sustainability.

Competitive Challenges and Risks

Despite its strengths, Sanofi faces challenges:

  • Intense Competition: Every segment, from vaccines to oncology, is highly competitive, with players like Pfizer, Moderna, Johnson & Johnson, and Novartis aggressively innovating.
  • Pricing Pressures: US payers' emphasis on cost containment compels Sanofi to optimize pricing strategies and demonstrate value.
  • Regulatory Uncertainty: Evolving FDA policies and reimbursement landscapes necessitate adaptive strategies.
  • Pipeline Uncertainties: The success of pipeline candidates remains uncertain, underscoring the importance of sustained R&D investment.

Outlook and Strategic Recommendations

Sanofi's US-market prospects hinge on leveraging its vaccine expertise, expanding its specialty portfolio, and accelerating digital initiatives. Continuous innovation, strategic partnerships, and proactive market access management will be pivotal.

Investment in emerging therapeutic areas such as gene editing and precision medicine could create substantial growth opportunities. Additionally, enhancing patient engagement through digital health services will improve adherence and brand loyalty.

Key Takeaways

  • Sanofi’s diversified portfolio and innovation capacity position it favorably within the US pharmaceutical landscape.
  • The company's emphasis on vaccines and rare diseases aligns with global health priorities, fostering sustainable revenue streams.
  • Strategic collaborations bolster Sanofi’s pipeline and technological edge, especially in mRNA vaccine development.
  • Navigating pricing pressures and regulatory landscapes requires sophisticated market access strategies.
  • Investing in digital transformation and emerging therapies will be critical to sustaining competitive advantage.

FAQs

1. How does Sanofi’s US market share compare to its global position?
Sanofi holds approximately 5-7% of the US prescription market, whereas globally, it ranks among the top ten pharma companies, driven by its diversified portfolio across regions.

2. What are Sanofi’s key growth areas in the US?
Major growth drivers include vaccines, especially influenza and emerging mRNA vaccines, as well as specialty care segments such as rare diseases and oncology.

3. How is Sanofi responding to biosimilar competition?
Sanofi is developing biosimilars for high-revenue biologics like insulin and monoclonal antibodies, aiming to retain market share amid biosimilar adoption.

4. What role does digital innovation play in Sanofi’s US strategy?
Digital tools are central, enhancing clinical trials, patient engagement, and pharmacovigilance, reducing costs, and accelerating drug development.

5. What are the future challenges Sanofi might face in the US?
Key challenges include pricing pressures from payers, regulatory hurdles, intense competition, and the uncertain success rate of pipeline products.

References

  1. IQVIA (2022). US Prescription Market Data.
  2. Sanofi Annual Report (2022).
  3. Sanofi Press Releases and Strategic Updates (2022).

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.