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Sanofi Company Profile

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

SANOFI has one hundred and fifty approved drugs.

There are seventy-three US patents protecting SANOFI drugs.

Summary for Sanofi

US Patents:	73
Tradenames:	125
Ingredients:	100
NDAs:	150
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	DEMI-REGROTON	chlorthalidone; reserpine	TABLET;ORAL	015103-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	PRESAMINE	imipramine hydrochloride	TABLET;ORAL	011836-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	TILADE	nedocromil sodium	SOLUTION;INHALATION	020750-001	Oct 1, 1997		DISCN	No	No

Expired US Patents for Sanofi

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	CEPHULAC	lactulose	SOLUTION;ORAL, RECTAL	017657-001	Approved Prior to Jan 1, 1982	3,558,774
Sanofi Aventis Us	CHILDREN'S ALLEGRA ALLERGY	fexofenadine hydrochloride	SUSPENSION;ORAL	201373-001	Jan 24, 2011	6,399,632*PED
Sanofi	RENVELA	sevelamer carbonate	TABLET;ORAL	022127-001	Oct 19, 2007	5,496,545

Paragraph IV (Patent) Challenges for SANOFI drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Injection	5 mg/mL, 10 mL and 20 mL vials		2007-02-09
	Injection	200 mg/40 mL		2007-07-16
	Extended-release Tablets	6.25 mg		2006-02-24
	Tablets	7 mg and 14 mg		2016-09-12
	Injection	2 mcg/mL, 2 mL ampules		2007-10-15
	Tablets	300 mg/25 mg		2006-06-06
	Injection	2 mcg/mL, 1 mL in 2 mL vial		2011-12-28
	Tablets	400 mg		2013-07-01
	Powder for Oral Suspension	0.8 g/packet and 2.4 g/packet		2009-12-30
	Tablets	150 mg		2007-10-30
	Transdermal System	7 mg/24 hrs, 14 mg/24 hrs, and 21 mg/24 hrs		2014-05-30
	Tablets	5 mg		2007-12-17
	Injection	100 mg/mL, 3 mL vials		2006-12-07
	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	12.5 mg		2006-01-19
	Capsules	0.5 mcg and 2.5 mcg		2009-03-25
	Tablets	150 mg/12.5 mg and 300 mg/12.5 mg		2004-11-10
	Capsules	1 mcg		2010-02-12
	Tablets	75 mg, 150 mg and 300 mg		2004-05-25
	Tablets	800 mg		2008-12-04
	Tablets	300 mg		2009-03-04
	Oral Suspension	30 mg/5 mL		2010-01-25
	Oral Solution	0.5 mg/mL		2009-01-14
	Injection	40 mg/mL, 0.5 mL and 2 mL vials		2009-06-30

Premature patent expirations for SANOFI

Expiration due to failure to pay maintenance fee

Patent Number	Expiration Date

Non-Orange Book US Patents for Sanofi

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,147,870	Osmotic device containing pseudoephedrine and an H1 antagonist
6,528,486	Peptide agonists of GLP-1 activity
6,569,898	United States Patent: 6569898   ( 1

International Patents for Sanofi Drugs

Country	Document Number	Estimated Expiration
South Korea	101040029
Mexico	2013002244
Germany	60003182

Supplementary Protection Certificates for Sanofi Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0596	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
0883	Netherlands		PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
00021	Netherlands		PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623

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