Last Updated: April 29, 2026

SANOFI AVENTIS US Company Profile


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Summary for SANOFI AVENTIS US
International Patents:219
US Patents:11
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 ISUPREL isoproterenol hydrochloride AEROSOL, METERED;INHALATION 011178-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us NOVAFED pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 017603-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us NITRO-BID nitroglycerin INJECTABLE;INJECTION 018621-001 Jan 5, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us TRANCOPAL chlormezanone TABLET;ORAL 011467-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-003 Aug 31, 1998 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial
>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 PERTOFRANE desipramine hydrochloride CAPSULE;ORAL 013621-002 Approved Prior to Jan 1, 1982 3,454,554 ⤷  Start Trial
Sanofi Aventis Us INTAL cromolyn sodium CAPSULE;INHALATION 016990-001 Approved Prior to Jan 1, 1982 3,419,578 ⤷  Start Trial
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-002 Jan 30, 1998 4,486,420 ⤷  Start Trial
Sanofi Aventis Us CEPHULAC lactulose SOLUTION;ORAL, RECTAL 017657-001 Approved Prior to Jan 1, 1982 3,867,524 ⤷  Start Trial
Sanofi Aventis Us PENETREX enoxacin TABLET;ORAL 019616-005 Dec 31, 1991 4,352,803 ⤷  Start Trial
>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 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
➤ 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

Supplementary Protection Certificates for SANOFI AVENTIS US Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1174135 SPC/GB10/011 United Kingdom ⤷  Start Trial PRODUCT NAME: THE COMBINATION OF PIOGLITAZONE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY THE HYDROCHLORIDE SALT, AND GLIMEPIRIDE.; REGISTERED: UK EU/1/06/366/001 20070108; UK EU/1/06/366/002 20070108; UK EU/1/06/366/003 20070108; UK EU/1/06/366/004 20070108; UK EU/1/06/366/005 20070108; UK EU/1/06/366/006 20070108; UK EU/1/06/366/019 20070108; UK EU/1/06/366/020 20070108; UK EU/1/06/366/021 20070108; UK EU/1/06/366/022 20070108; UK EU/1/06/366/013 20070108; UK EU/1/06/366/014 20070108; UK EU/1/06/366/015 20070108; UK EU/1/06/366/016 20070108; UK EU/1/06/366/017 20070108; UK EU/1/06/366/018 20070108; UK EU/1/06/366/007 20070108; UK EU/1/06/366/008 20070108; UK EU
0145340 99C0005 Belgium ⤷  Start Trial PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
1667986 CA 2013 00025 Denmark ⤷  Start Trial
2673237 201940014 Slovenia ⤷  Start Trial PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; NATIONAL AUTHORISATION NUMBER: EU/1/17/1173; DATE OF NATIONAL AUTHORISATION: 20180322; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2932970 18C1043 France ⤷  Start Trial PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
>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: March 28, 2026

What is Sanofi Aventis US’s current market position?

Sanofi Aventis US ranks among the top ten pharmaceutical companies by revenue in the US outpatient prescription drug market. In 2022, it generated approximately $18.5 billion in US prescription sales, holding an estimated 3.8% market share. Its core portfolio includes vaccines, diabetes treatments, and specialty care drugs.

What are Sanofi Aventis US’s key strengths?

Diverse Portfolio and Leading Products

Sanofi’s US portfolio includes diabetes medications such as Lantus (insulin glargine), multiple vaccines like Fluzone and Dengvaxia, and specialty drugs including Sarclisa for multiple myeloma. These products have sustained revenues and high market penetration.

R&D Capabilities and Pipeline

The company invests roughly 20% of revenue into R&D, amounting to over $3.7 billion in 2022. Its pipeline comprises 125 active compounds focused on immunology, oncology, and rare diseases. Strategic collaborations enhance its innovation capabilities.

Regulatory Approvals and Market Access

Sanofi has secured FDA approval for multiple drugs in recent years, including Entresto (heart failure) in 2019. Its vaccine segment benefits from CDC-backed immunization programs, ensuring broad market access.

Strategic Alliances

Partnerships with biotechnology firms and academic institutions augment its R&D and commercialization efforts. Collaborations with Regeneron have yielded blockbuster drugs such as Dupixent (atopic dermatitis).

How does Sanofi Aventis US compare with key competitors?

Company US Market Share (2022) Core Focus Areas Notable Products R&D Investment (2022)
Pfizer 11.2% Vaccines, Oncology, Rare Diseases Comirnaty, Ibrance $13.8 billion
Johnson & Johnson 8.7% Vaccines, Immunology, Oncology Darzalex, Janssen vaccines $8.7 billion
Merck & Co. 8.1% Oncology, Vaccines, Infectious Diseases Keytruda, Gardasil $11.4 billion
Sanofi Aventis US 3.8% Vaccines, Diabetes, Specialty Care Lantus, Dupixent, Fluzone $3.7 billion

Sanofi’s niche focus on vaccines and rare diseases differentiates it from peers. Its vaccine sales are resilient, accounting for roughly 25% of total revenue, compared to significant declines in other segments.

What strategic initiatives are shaping Sanofi Aventis US’s future?

Expanding Vaccine Portfolio

Sanofi invests in next-generation vaccines targeting respiratory diseases and emerging infectious threats. The launch of mRNA-based vaccine candidates aims to compete with Moderna and Pfizer.

Focus on Rare Diseases and Oncology

Pipeline expansion emphasizes gene therapies and monoclonal antibodies. Sanofi’s recent FDA approval of Altuvii for hemophilia A demonstrates its commitment to innovative treatments.

Digital Transformation and Data Analytics

Implementation of digital clinical trials and real-world evidence platforms enhances R&D efficiency. Collaborations with tech firms improve data-driven decision-making.

Market Access and Pricing Strategies

Sanofi adopts value-based pricing models, aligns with payers on reimbursement policies, and increases patient assistance programs. It aims to mitigate pricing pressures from biosimilar entrants.

What are recent challenges and risks?

  • Patent expirations of key products like Lantus in 2024 threaten revenue declines.
  • Competition intensifies in diabetes and immunology segments from biosimilar entrants.
  • Regulatory hurdles and delays in pipeline approvals may impact market entry strategies.
  • Pricing and reimbursement pressures from insurers and government programs increase financial risk.

What are the implications for investors or partners?

Sanofi’s balanced portfolio, strategic pipeline, and focus on vaccines position it to maintain relevance amid competitive pressures. Its investments in innovation and market access aim to stabilize revenue streams. However, patent expirations and market competition require active management and strategic agility.

Key Takeaways

  • Sanofi Aventis US holds a significant but smaller share of the US pharmaceutical market, focusing on vaccines, diabetes, and rare diseases.
  • Strengths include a diversified product portfolio, substantial R&D investments, and strategic alliances.
  • The company aims to expand its vaccine offerings, advance its rare disease pipeline, and leverage digital tools.
  • Challenges involve patent cliffs, biosimilar competition, and regulatory delays.
  • Sustained growth depends on pipeline development, market access strategies, and adaptation to competitive dynamics.

FAQs

1. How does Sanofi’s vaccine segment impact its overall revenue?
Vaccine sales account for 25% of Sanofi’s total revenue in the US, providing stability amid declines in other segments.

2. What are the next key product approvals expected for Sanofi US?
Pipeline candidates in immunology and oncology, including gene therapies and monoclonal antibodies, anticipate FDA review over the next 12-24 months.

3. How competitive is Sanofi’s pipeline?
With 125 active compounds and collaborations, Sanofi’s pipeline is robust but faces competition from big biotech and pharmaceutical firms.

4. What market risks could affect Sanofi US’s growth?
Patent expirations, biosimilar competition, pricing pressures, and regulatory delays pose primary risks.

5. How does Sanofi differentiate itself from competitors?
Sanofi’s focus on vaccines and rare diseases, coupled with strategic alliances and innovative pipeline, distinguishes it from larger peers primarily focused on oncology and general medicine.

References
[1] Sanofi annual report 2022.
[2] IQVIA. (2022). US prescription market data.
[3] EvaluatePharma. (2022). R&D investment report.
[4] U.S. Food and Drug Administration. (2023). Drug approvals and guidance.

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