Sanofi Company Profile

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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	KERLEDEX	betaxolol hydrochloride; chlorthalidone	TABLET;ORAL	019807-002	Oct 30, 1992		DISCN	No	No
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-002	Jan 30, 1998	AP	RX	Yes	No
Sanofi Aventis Us	ISUPREL	isoproterenol hydrochloride	TABLET;RECTAL, SUBLINGUAL	006328-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	TALACEN	acetaminophen; pentazocine hydrochloride	TABLET;ORAL	018458-001	Sep 23, 1982		DISCN	No	No
Sanofi Aventis Us	PRIMAQUINE	primaquine phosphate	TABLET;ORAL	008316-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for Sanofi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-003	Jul 13, 2009	5,602,116
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984	4,060,634
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-001	May 1, 1984	3,426,067
Sanofi Aventis Us	DIABETA	glyburide	TABLET;ORAL	017532-003	May 1, 1984	3,507,954
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-006	Jun 2, 2000	RE38743

Paragraph IV (Patent) Challenges for SANOFI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	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

International Patents for Sanofi Drugs

Country	Patent Number	Estimated Expiration
Germany	60226855
Israel	218492
Canada	2539309
South Africa	200602255
Montenegro	02765

Supplementary Protection Certificates for Sanofi Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2768484	2019041	Norway		PRODUCT NAME: KOMBINASJON AV DAUNORUBICIN OG CYTARABIN; REG. NO/DATE: EU/1/18/1308 20180831
1667986	13C0037	France		PRODUCT NAME: CABAZITAXEL SOUS FORME ACETONATE (OU SOLVAT ACETONIQUE DU CABAZITAXEL); REGISTRATION NO/DATE: EU/1/11/676/001 20110322
3300601	122022000044	Germany		PRODUCT NAME: KOMBINATION VON DAUNORUBICIN UND CYTARABIN; REGISTRATION NO/DATE: EU/1/18/1308 20180823
2203431	201540014	Slovenia		PRODUCT NAME: DASABUVIR OR ITS SALT INCLUDING DASABUVIR AS SODIUM MONOHYDRATE; NATIONAL AUTHORISATION NUMBER: EU/1/14/983/001; DATE OF NATIONAL AUTHORISATION: 20150115; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3185856	CR 2024 00001	Denmark		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: 66650 20230704; FIRST REG. NO/DATE: NL RVG 128835 20230216

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