Sanofi Company Profile

What is the competitive landscape for SANOFI

SANOFI has one hundred and twenty-four approved drugs.

There are eleven US patents protecting SANOFI drugs.

Summary for Sanofi

US Patents:	11
Tradenames:	99
Ingredients:	89
NDAs:	124
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

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	LOZOL	indapamide	TABLET;ORAL	018538-002	Apr 29, 1993		DISCN	Yes	No
Sanofi Aventis Us	REGROTON	chlorthalidone; reserpine	TABLET;ORAL	015103-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	ISUPREL	isoproterenol hydrochloride	SOLUTION;INHALATION	006327-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-002	Sep 30, 1997	AB	RX	Yes	No

Expired US Patents for Sanofi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-001	May 1, 1984	3,454,635
Sanofi Aventis Us	TALACEN	acetaminophen; pentazocine hydrochloride	TABLET;ORAL	018458-001	Sep 23, 1982	4,105,659
Sanofi Aventis Us	BRICANYL	terbutaline sulfate	TABLET;ORAL	017618-002	Approved Prior to Jan 1, 1982	3,937,838
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-005	Dec 31, 1991	4,442,101

Paragraph IV (Patent) Challenges for SANOFI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Tablets	7 mg and 14 mg		2016-09-12
	Tablets	300 mg/25 mg		2006-06-06
	Capsules	0.4 mg		2004-12-20
	Tablets	400 mg		2013-07-01
	Injection	2 mcg/mL, 2 mL ampules		2007-10-15
	Injection	2 mcg/mL, 1 mL in 2 mL vial		2011-12-28
	Powder for Oral Suspension	0.8 g/packet and 2.4 g/packet		2009-12-30
	Injection	5 mg/mL, 10 mL and 20 mL vials		2007-02-09
	Injection	200 mg/40 mL		2007-07-16
	Injection	100 mg/mL, 3 mL vials		2006-12-07
	Tablets	150 mg/12.5 mg and 300 mg/12.5 mg		2004-11-10
	Tablets	75 mg, 150 mg and 300 mg		2004-05-25
	Capsules	0.5 mcg and 2.5 mcg		2009-03-25
	Tablets	300 mg		2009-03-04
	Capsules	1 mcg		2010-02-12
	Tablets	800 mg		2008-12-04
	Injection	40 mg/mL, 0.5 mL and 2 mL vials		2009-06-30
	For Injection	50 mg/vial and 100 mg/vial		2007-02-09
	Injection	5 mg/mL, 40 mL vial		2011-03-23

International Patents for Sanofi Drugs

Country	Patent Number	Estimated Expiration
Argentina	045667
Nicaragua	201000172
Serbia	54614
Japan	2013509394

Supplementary Protection Certificates for Sanofi Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	SPC/GB18/041	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
3347352	LUC00292	Luxembourg		PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/22/1671 20220819
1874117	2014/032	Ireland		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
2768484	LUC00135	Luxembourg		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; AUTHORISATION NUMBER AND DATE: EU/1/18/1308 20180827

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Sanochemia Corp Usa
• Sanofi
• Sanofi Aventis Us