Last Updated: June 18, 2026

Sanofi Aventis Us Company Profile


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Summary for Sanofi Aventis Us
International Patents:221
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 TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 DISCN Yes No ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us SLO-PHYLLIN theophylline TABLET;ORAL 085202-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes 8,410,167 ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 RX Yes Yes 9,107,900 ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us PRESAMINE imipramine hydrochloride TABLET;ORAL 011836-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us PHISOHEX hexachlorophene EMULSION;TOPICAL 008402-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER milrinone lactate INJECTABLE;INJECTION 020343-003 Aug 9, 1994 DISCN Yes No ⤷  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 PENETREX enoxacin TABLET;ORAL 019616-004 Dec 31, 1991 4,359,578 ⤷  Start Trial
Sanofi Aventis Us TORNALATE bitolterol mesylate AEROSOL, METERED;INHALATION 018770-001 Dec 28, 1984 4,336,400 ⤷  Start Trial
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-005 Mar 27, 1998 RE38743 ⤷  Start Trial
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-001 Approved Prior to Jan 1, 1982 4,011,258 ⤷  Start Trial
Sanofi Aventis Us LOVENOX (PRESERVATIVE FREE) enoxaparin sodium INJECTABLE;SUBCUTANEOUS 020164-008 Jun 2, 2000 RE38743 ⤷  Start Trial
Sanofi Aventis Us DIABETA glyburide TABLET;ORAL 017532-002 May 1, 1984 3,507,954 ⤷  Start Trial
Sanofi Aventis Us TORNALATE bitolterol mesylate SOLUTION;INHALATION 019548-001 Feb 19, 1992 4,336,400 ⤷  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 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
➤ Subscribe Tablets 300 mg ➤ Subscribe 2009-03-04

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 ⤷  Start Trial 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
2666774 SPC/GB20/031 United Kingdom ⤷  Start Trial PRODUCT NAME: RELEBACTAM OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT.; REGISTERED: UK EU/1/19/1420 (NI) 20200217; UK PLGB 53095/0053 20200217
3300601 CA 2022 00030 Denmark ⤷  Start Trial PRODUCT NAME: KOMBINATION AF DAUNORUBICIN OG CYTARABIN; REG. NO/DATE: EU/1/18/1308 20180827
2822954 SPC/GB18/031 United Kingdom ⤷  Start Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625
3300601 2290030-2 Sweden ⤷  Start Trial PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REG. NO/DATE: EU/1/18/1308 20180827
1007030 2010008 Ireland ⤷  Start Trial THE CORRECT SPC EXTENSION DATE IS 20230618 (NOT 20230616); PRODUCT NAME: DRONEDARONE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/09/591/001-004 20091126
1667986 141 5019-2013 Slovakia ⤷  Start Trial FIRST REGISTRATION NO/DATE: EU/1/11/676/001 20110317
>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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