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Sanofi Company Profile

What is the competitive landscape for SANOFI, and what generic alternatives to SANOFI drugs are available?

SANOFI has one hundred and fifty-one approved drugs.

There are sixty-seven US patents protecting SANOFI drugs.

There are one thousand two hundred and eighty-nine patent family members on SANOFI drugs in seventy countries and two hundred and two supplementary protection certificates in eighteen countries.

Summary for Sanofi

International Patents:	1289
US Patents:	67
Tradenames:	126
Ingredients:	101
NDAs:	151
Patent Litigation for Sanofi:	See patent lawsuits for Sanofi
PTAB Cases with Sanofi as petitioner:	See PTAB cases with Sanofi as petitioner

Drugs and US Patents for Sanofi

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Glossary

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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	APIDRA	insulin glulisine recombinant	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021629-002	Dec 20, 2005		DISCN	Yes	No	7,696,162	➤ Sign Up	Y			➤ Sign Up
Sanofi Aventis Us	ALLEGRA	fexofenadine hydrochloride	SUSPENSION;ORAL	021963-001	Oct 16, 2006		DISCN	Yes	No		➤ Sign Up				➤ Sign Up
Sanofi Aventis Us	TORNALATE	bitolterol mesylate	AEROSOL, METERED;INHALATION	018770-001	Dec 28, 1984		DISCN	No	No		➤ Sign Up				➤ Sign Up
Sanofi Aventis Us	APIDRA SOLOSTAR	insulin glulisine recombinant	INJECTABLE;SUBCUTANEOUS	021629-003	Feb 24, 2009		RX	Yes	No	9,604,008	➤ Sign Up	Y			➤ Sign Up
Sanofi-aventis Us	SOLIQUA 100/33	insulin glargine; lixisenatide	SOLUTION;SUBCUTANEOUS	208673-001	Nov 21, 2016		RX	Yes	Yes	9,526,844	➤ Sign Up	Y			➤ Sign Up
Sanofi-aventis Us	SOLIQUA 100/33	insulin glargine; lixisenatide	SOLUTION;SUBCUTANEOUS	208673-001	Nov 21, 2016		RX	Yes	Yes	8,556,864	➤ Sign Up	Y			➤ Sign Up
Sanofi Aventis Us	ARALEN HYDROCHLORIDE	chloroquine hydrochloride	INJECTABLE;INJECTION	006002-002	Approved Prior to Jan 1, 1982		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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-004	Aug 2, 2010	5,714,512*PED	➤ Sign Up
Sanofi Aventis Us	ALLEGRA HIVES	fexofenadine hydrochloride	TABLET;ORAL	020872-009	Jan 24, 2011	5,578,610*PED	➤ Sign Up
Sanofi Aventis Us	ALLEGRA HIVES	fexofenadine hydrochloride	TABLET;ORAL	020872-008	Jan 24, 2011	7,135,571*PED	➤ Sign Up
Sanofi Aventis Us	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021909-002	Jan 24, 2011	6,187,791	➤ Sign Up
Sanofi Aventis Us	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-007	Jan 24, 2011	6,037,353*PED	➤ Sign Up
Sanofi Aventis Us	ALLEGRA ALLERGY	fexofenadine hydrochloride	TABLET;ORAL	020872-007	Jan 24, 2011	6,399,632*PED	➤ Sign Up
Sanofi Aventis Us	ALLEGRA HIVES	fexofenadine hydrochloride	TABLET;ORAL	020872-009	Jan 24, 2011	5,932,247*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	Powder for Oral Suspension	0.8 g/packet and 2.4 g/packet	➤ Subscribe	2009-12-30
➤ Subscribe	Tablets	75 mg, 150 mg and 300 mg	➤ Subscribe	2004-05-25
➤ Subscribe	Capsules	0.4 mg	➤ Subscribe	2004-12-20
➤ 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	Oral Solution	0.5 mg/mL	➤ Subscribe	2009-01-14
➤ Subscribe	Capsules	0.5 mcg and 2.5 mcg	➤ Subscribe	2009-03-25
➤ Subscribe	Extended-release Tablets	6.25 mg	➤ Subscribe	2006-02-24
➤ Subscribe	Capsules	1 mcg	➤ Subscribe	2010-02-12
➤ Subscribe	Tablets	7 mg and 14 mg	➤ Subscribe	2016-09-12
➤ Subscribe	Tablets	800 mg	➤ Subscribe	2008-12-04
➤ Subscribe	Tablets	300 mg/25 mg	➤ Subscribe	2006-06-06
➤ Subscribe	Oral Suspension	30 mg/5 mL	➤ Subscribe	2010-01-25
➤ Subscribe	Tablets	400 mg	➤ Subscribe	2013-07-01
➤ Subscribe	Transdermal System	7 mg/24 hrs, 14 mg/24 hrs, and 21 mg/24 hrs	➤ Subscribe	2014-05-30
➤ Subscribe	Tablets	150 mg	➤ Subscribe	2007-10-30
➤ 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
➤ Subscribe	Injection	100 mg/mL, 3 mL vials	➤ Subscribe	2006-12-07
➤ Subscribe	Tablets	5 mg	➤ Subscribe	2007-12-17
➤ Subscribe	Injection	2 mcg/mL, 2 mL ampules	➤ Subscribe	2007-10-15
➤ Subscribe	Extended-release Tablets	12.5 mg	➤ Subscribe	2006-01-19
➤ Subscribe	Injection	2 mcg/mL, 1 mL in 2 mL vial	➤ Subscribe	2011-12-28
➤ Subscribe	Tablets	150 mg/12.5 mg and 300 mg/12.5 mg	➤ Subscribe	2004-11-10

Premature patent expirations for SANOFI

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date
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International Patents for Sanofi Drugs

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Country	Patent Number	Estimated Expiration
Norway	326780	➤ Sign Up
China	102256618	➤ Sign Up
Denmark	1603611	➤ Sign Up
Spain	2625731	➤ Sign Up
Denmark	2281592	➤ Sign Up
World Intellectual Property Organization (WIPO)	2004078241	➤ Sign Up
Argentina	078383	➤ Sign Up
Country	Patent Number	Estimated Expiration

Supplementary Protection Certificates for Sanofi Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203431	1590018-6	Sweden	➤ Sign Up	PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
2498802	2017/022	Ireland	➤ Sign Up	PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111
0281459	35/1998	Austria	➤ Sign Up	PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
1196444	2013/015	Ireland	➤ Sign Up	PRODUCT NAME: LIXISENATIDE; NAT REGISTRATION NO/DATE: EU/1/12/811/001 20130201; FIRST REGISTRATION NO/DATE: EU/1/12/811/002 01/02/2013 IRELAND EU/1/12/811/003 01/02/2013 IRELAND EU/1/12/811/004 01/02/2013 IRELAND EU/1/12/811/005 20130201
1007030	SPC/GB10/029	United Kingdom	➤ Sign Up	PRODUCT NAME: DRONEDARONE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/09/591/001 20091126; UK EU/1/09/591/002 20091126; UK EU/1/09/591/003 20091126; UK EU/1/09/591/004 20091126
2107069	1390036-0	Sweden	➤ Sign Up	PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
1744764	300960	Netherlands	➤ Sign Up	PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
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.

Summary for Sanofi

Paragraph IV (Patent) Challenges for SANOFI drugs

Premature patent expirations for SANOFI

Expiration due to failure to pay maintenance fee

Similar Applicant Names

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