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	ARALEN HYDROCHLORIDE	chloroquine hydrochloride	INJECTABLE;INJECTION	006002-002	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	PRESAMINE	imipramine hydrochloride	TABLET;ORAL	011836-003	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	TALWIN 50	pentazocine hydrochloride	TABLET;ORAL	016732-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	SLO-PHYLLIN	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	085203-001	May 24, 1982		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	SKELID	tiludronate disodium	TABLET;ORAL	020707-001	Mar 7, 1997		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	SLO-BID	theophylline	CAPSULE, EXTENDED RELEASE;ORAL	089540-001	May 10, 1989		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
>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	SKELID	tiludronate disodium	TABLET;ORAL	020707-001	Mar 7, 1997	4,876,248	⤷ Try a Trial
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-005	Mar 27, 1998	4,486,420	⤷ Try a Trial
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-001	Jan 31, 2005	5,420,319*PED	⤷ Try a Trial
Sanofi Aventis Us	PRIMACOR	milrinone lactate	INJECTABLE;INJECTION	019436-001	Dec 31, 1987	4,313,951*PED	⤷ Try a Trial
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-003	Mar 27, 1998	4,692,435	⤷ Try a Trial
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-002	Jan 30, 1998	4,692,435	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Country	Patent Number	Estimated Expiration
France	2930148	⤷ Try a Trial
El Salvador	2012004192	⤷ Try a Trial
Eurasian Patent Organization	025017	⤷ Try a Trial
Spain	2621553	⤷ Try a Trial
Ecuador	SP12011836	⤷ Try a Trial
European Patent Office	1807057	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1667986	C300595	Netherlands	⤷ Try a Trial	PRODUCT NAME: CABAZITAXEL ACETONAAT; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
0716606	6/2002	Austria	⤷ Try a Trial	PRODUCT NAME: SEVELAMER SOWIE DESSEN PHARMAZEUTISCH VERTRAEGLICHEN SALZE; REGISTRATION NO/DATE: EU/1/99/123/001 - EU/1/99/123/004 20000128
0716606	C00716606/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: SEVELAMER; REGISTRATION NUMBER/DATE: SWISSMEDIC 56297 10.02.2004
1381356	SPC/GB14/011	United Kingdom	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/838/001-005 20130829
0503785	CA 2011 00026	Denmark	⤷ Try a Trial	PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
2768484	2019/054	Ireland	⤷ Try a Trial	PRODUCT NAME: COMBINATION OF DAUNORUBICIN AND CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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