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	MYTELASE	ambenonium chloride	TABLET;ORAL	010155-002	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	PARATHAR	teriparatide acetate	INJECTABLE;INJECTION	019498-001	Dec 23, 1987		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-001	Aug 9, 2002		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	CALCIPARINE	heparin calcium	INJECTABLE;INJECTION	018237-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	ISUPREL	isoproterenol hydrochloride	AEROSOL, METERED;INHALATION	011178-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-004	Dec 31, 1991		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	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	6,903,083	⤷ Try a Trial
Sanofi Aventis Us	AVALIDE	hydrochlorothiazide; irbesartan	TABLET;ORAL	020758-002	Sep 30, 1997	5,994,348*PED	⤷ Try a Trial
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-002	Apr 23, 2004	5,602,116	⤷ Try a Trial
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-003	Nov 17, 2006	5,716,988*PED	⤷ Try a Trial
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-002	Feb 9, 2005	D459798	⤷ Try a Trial
Sanofi Aventis Us	AMBIEN	zolpidem tartrate	TABLET;ORAL	019908-002	Dec 16, 1992	4,382,938*PED	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0302769	98C0036	Belgium	⤷ Try a Trial	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
2344130	122017000073	Germany	⤷ Try a Trial	PRODUCT NAME: OZENOXACIN; NAT. REGISTRATION NO/DATE: 97303.00.00 20170803; FIRST REGISTRATION: BELGIEN BE509591 20170517
1667986	1390025-3	Sweden	⤷ Try a Trial	PRODUCT NAME: CABAZITAXEL ACETONSOLVAT; REG. NO/DATE: EU/1/11/676/001 20110317
0502314	C300095	Netherlands	⤷ Try a Trial	PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
2768484	2019041	Norway	⤷ Try a Trial	PRODUCT NAME: KOMBINASJON AV DAUNORUBICIN OG CYTARABIN; REG. NO/DATE: EU/1/18/1308 20180831
2344130	1790031-7	Sweden	⤷ Try a Trial	PRODUCT NAME: OZENOXACIN; NAT. REG. NO/DATE: 54608 20170622; FIRST REG.: BE ES/H/414/01/DC 20170519
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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