Sanofi Company Profile

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

SANOFI has one hundred and twenty-seven approved drugs.

There are eleven US patents protecting SANOFI drugs.

There are two hundred and thirty-seven patent family members on SANOFI drugs in fifty-two countries and one hundred and twenty-two supplementary protection certificates in nineteen countries.

Summary for Sanofi

International Patents:	237
US Patents:	11
Tradenames:	101
Ingredients:	89
NDAs:	127
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	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No	6,794,410*PED				Y
Sanofi Aventis Us	METAHYDRIN	trichlormethiazide	TABLET;ORAL	012594-002	Jun 16, 1988		DISCN	No	No
Sanofi Aventis Us	SLO-BID	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	088269-001	Jan 31, 1985		DISCN	No	No
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757-002	Sep 30, 1997	AB	RX	Yes	No
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sanofi Aventis Us	ISUPREL	isoproterenol hydrochloride	SOLUTION;INHALATION	006327-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-004	Aug 2, 2010	AP	RX	Yes	Yes

Expired US Patents for Sanofi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-002	Sep 20, 2007	6,429,210*PED
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-003	Nov 17, 2006	5,290,961*PED
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-004	Mar 27, 1998	5,389,618
Sanofi Aventis Us	ORNIDYL	eflornithine hydrochloride	INJECTABLE;INJECTION	019879-002	Nov 28, 1990	4,413,141
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007	7,014,846
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-005	Dec 31, 1991	4,352,803
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-003	Mar 27, 1998	4,486,420

Paragraph IV (Patent) Challenges for SANOFI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Extended-release Tablets	6.25 mg		2006-02-24
	Tablets	7 mg and 14 mg		2016-09-12
	Capsules	0.4 mg		2004-12-20
	Tablets	300 mg/25 mg		2006-06-06
	Injection	2 mcg/mL, 2 mL ampules		2007-10-15
	Tablets	400 mg		2013-07-01
	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
	Extended-release Tablets	12.5 mg		2006-01-19
	Tablets	150 mg/12.5 mg and 300 mg/12.5 mg		2004-11-10
	Capsules	0.5 mcg and 2.5 mcg		2009-03-25
	Tablets	75 mg, 150 mg and 300 mg		2004-05-25
	Capsules	1 mcg		2010-02-12
	Tablets	300 mg		2009-03-04

International Patents for Sanofi Drugs

Country	Patent Number	Estimated Expiration
Russian Federation	2012115459
Poland	1807057
Panama	8542901
Cyprus	1119364
Serbia	20060189
Morocco	33585
Spain	2625731

Supplementary Protection Certificates for Sanofi Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.
2768484	53/2019	Austria		PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 (MITTEILUNG) 20180827
2768484	301016	Netherlands		PRODUCT NAME: COMBINATIE VAN DAUNORUBICINE EN CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
2236132	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
0680967	01C0055	France		PRODUCT NAME: TELITHROMYCINE; REGISTRATION NO/DATE: EU/1/01/191/001 20010709
1744764	2018/042	Ireland		PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180823
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718

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