Sanofi Company Profile

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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.

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

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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	ISUPREL	isoproterenol hydrochloride	TABLET;RECTAL, SUBLINGUAL	006328-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	LORELCO	probucol	TABLET;ORAL	017535-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Sanofi	HECTOROL	doxercalciferol	INJECTABLE;INJECTION	021027-002	Apr 6, 2000	AP	RX	Yes	No		⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	INTAL	cromolyn sodium	CAPSULE;INHALATION	016990-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-002	Aug 9, 1994		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	KERLONE	betaxolol hydrochloride	TABLET;ORAL	019507-002	Oct 27, 1989		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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-001	May 14, 1996	5,438,072*PED	⤷ Sign Up
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	7,323,493	⤷ Sign Up
Sanofi Aventis Us	MULTAQ	dronedarone hydrochloride	TABLET;ORAL	022425-001	Jul 1, 2009	8,318,800	⤷ Sign Up
Sanofi Aventis Us	PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	020343-003	Aug 9, 1994	4,313,951*PED	⤷ Sign Up
Sanofi Aventis Us	ARAVA	leflunomide	TABLET;ORAL	020905-003	Sep 10, 1998	5,679,709	⤷ Sign Up
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,869,473	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Injection	100 mg/mL, 3 mL vials	➤ Subscribe	2006-12-07
➤ Subscribe	Extended-release Tablets	12.5 mg	➤ Subscribe	2006-01-19
➤ Subscribe	Tablets	150 mg/12.5 mg and 300 mg/12.5 mg	➤ Subscribe	2004-11-10
➤ Subscribe	Capsules	0.5 mcg and 2.5 mcg	➤ Subscribe	2009-03-25
➤ Subscribe	Tablets	75 mg, 150 mg and 300 mg	➤ Subscribe	2004-05-25
➤ Subscribe	Capsules	1 mcg	➤ Subscribe	2010-02-12
➤ Subscribe	Tablets	300 mg	➤ Subscribe	2009-03-04
➤ Subscribe	Tablets	800 mg	➤ Subscribe	2008-12-04
➤ 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	Extended-release Tablets	6.25 mg	➤ Subscribe	2006-02-24
➤ Subscribe	Tablets	7 mg and 14 mg	➤ Subscribe	2016-09-12
➤ Subscribe	Capsules	0.4 mg	➤ Subscribe	2004-12-20
➤ Subscribe	Tablets	300 mg/25 mg	➤ Subscribe	2006-06-06
➤ Subscribe	Injection	2 mcg/mL, 2 mL ampules	➤ Subscribe	2007-10-15
➤ Subscribe	Tablets	400 mg	➤ Subscribe	2013-07-01
➤ Subscribe	Injection	2 mcg/mL, 1 mL in 2 mL vial	➤ Subscribe	2011-12-28
➤ Subscribe	Powder for Oral Suspension	0.8 g/packet and 2.4 g/packet	➤ Subscribe	2009-12-30
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0281459	98C0036	France	⤷ Sign Up	PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
2236132	C300714	Netherlands	⤷ Sign Up	PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
0680967	01C0055	France	⤷ Sign Up	PRODUCT NAME: TELITHROMYCINE; REGISTRATION NO/DATE: EU/1/01/191/001 20010709
1381356	CR 2014 00005	Denmark	⤷ Sign Up	PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356	1490010-4	Sweden	⤷ Sign Up	PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
0502314	SPC/GB02/037	United Kingdom	⤷ Sign Up	PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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