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Last Updated: July 13, 2024

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 AZOLID phenylbutazone CAPSULE;ORAL 087260-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us TRANCOPAL chlormezanone TABLET;ORAL 011467-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us LORELCO probucol TABLET;ORAL 017535-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us JEVTANA KIT cabazitaxel SOLUTION;INTRAVENOUS 201023-001 Jun 17, 2010 AP RX Yes Yes 10,583,110 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us ELOXATIN oxaliplatin INJECTABLE;INTRAVENOUS 021492-001 Aug 9, 2002 DISCN Yes No ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us LOTUSATE talbutal TABLET;ORAL 009410-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us KETEK telithromycin TABLET;ORAL 021144-002 Feb 9, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up
>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 Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-001 Dec 16, 1992 4,382,938*PED ⤷  Sign Up
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 5,679,709 ⤷  Sign Up
Sanofi Aventis Us AVAPRO irbesartan TABLET;ORAL 020757-002 Sep 30, 1997 5,270,317*PED ⤷  Sign Up
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 6,509,013 ⤷  Sign Up
Sanofi Aventis Us BRICANYL terbutaline sulfate TABLET;ORAL 017618-001 Approved Prior to Jan 1, 1982 3,937,838 ⤷  Sign Up
Sanofi Aventis Us PLAVIX clopidogrel bisulfate TABLET;ORAL 020839-002 Sep 20, 2007 4,847,265*PED ⤷  Sign Up
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758-002 Sep 30, 1997 5,994,348*PED ⤷  Sign Up
>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 Injection 100 mg/mL, 3 mL vials ➤ Subscribe 2006-12-07
➤ Subscribe Extended-release Tablets 12.5 mg ➤ Subscribe 2006-01-19
➤ Subscribe Tablets 150 mg/12.5 mg and 300 mg/12.5 mg ➤ Subscribe 2004-11-10
➤ Subscribe Capsules 0.5 mcg and 2.5 mcg ➤ Subscribe 2009-03-25
➤ Subscribe Tablets 75 mg, 150 mg and 300 mg ➤ Subscribe 2004-05-25
➤ Subscribe Capsules 1 mcg ➤ Subscribe 2010-02-12
➤ Subscribe Tablets 300 mg ➤ Subscribe 2009-03-04
➤ 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 Extended-release Tablets 6.25 mg ➤ Subscribe 2006-02-24
➤ Subscribe Tablets 7 mg and 14 mg ➤ Subscribe 2016-09-12
➤ Subscribe Capsules 0.4 mg ➤ Subscribe 2004-12-20
➤ Subscribe Tablets 300 mg/25 mg ➤ Subscribe 2006-06-06
➤ Subscribe Injection 2 mcg/mL, 2 mL ampules ➤ Subscribe 2007-10-15
➤ Subscribe Tablets 400 mg ➤ Subscribe 2013-07-01
➤ Subscribe Injection 2 mcg/mL, 1 mL in 2 mL vial ➤ Subscribe 2011-12-28
➤ 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

Supplementary Protection Certificates for Sanofi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 CA 2015 00004 Denmark ⤷  Sign Up PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2768484 CA 2019 00051 Denmark ⤷  Sign Up PRODUCT NAME: KOMBINATION AF DAUNORUBICIN OG CYTARABIN; REG. NO/DATE: EU/1/18/1308 20180827
2344130 122017000073 Germany ⤷  Sign Up PRODUCT NAME: OZENOXACIN; NAT. REGISTRATION NO/DATE: 97303.00.00 20170803; FIRST REGISTRATION: BELGIEN BE509591 20170517
0100718 96C0006 Belgium ⤷  Sign Up PRODUCT NAME: TILUDRONATE DISODIQUE EXPRIME EN ACIDE TILUDRONIQUE; NAT. REGISTRATION NO/DATE: 201 IS 106 F 3 19950907; FIRST REGISTRATION: LI 53014 19950220
2344130 C201730036 Spain ⤷  Sign Up PRODUCT NAME: OZENOXACINO; NATIONAL AUTHORISATION NUMBER: 82357-ES/H/0414/001/DC; DATE OF AUTHORISATION: 20170830; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): ES/H/414/01/DC; DATE OF FIRST AUTHORISATION IN EEA: 20170519
1381356 14C0010 France ⤷  Sign Up PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1667986 C20130017 00077 Estonia ⤷  Sign Up PRODUCT NAME: KABASITAKSEEL;REG NO/DATE: K(2011)1888 LOPLIK 17.03.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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