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	FEXINIDAZOLE	fexinidazole	TABLET;ORAL	214429-001	Jul 16, 2021		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997	AB	RX	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-002	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	TALWIN NX	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	018733-001	Dec 16, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	NEGGRAM	nalidixic acid	SUSPENSION;ORAL	017430-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	ACTHAR	corticotropin	INJECTABLE;INJECTION	007504-003	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	RIFADIN	rifampin	CAPSULE;ORAL	050420-001	Approved Prior to Jan 1, 1982		DISCN	Yes	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	LOVENOX	enoxaparin sodium	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	020164-009	Jan 23, 2003	5,389,618	⤷ Try a Trial
Sanofi Aventis Us	LOVENOX (PRESERVATIVE FREE)	enoxaparin sodium	INJECTABLE;SUBCUTANEOUS	020164-005	Mar 27, 1998	RE38743	⤷ Try a Trial
Sanofi	HECTOROL	doxercalciferol	CAPSULE;ORAL	020862-001	Jun 9, 1999	5,602,116	⤷ Try a Trial
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-004	Aug 2, 2010	5,698,582*PED	⤷ Try a Trial
Sanofi Aventis Us	TALWIN NX	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	018733-001	Dec 16, 1982	4,105,659	⤷ Try a Trial
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023-001	Jun 17, 2010	5,438,072	⤷ Try a Trial
Sanofi Aventis Us	KETEK	telithromycin	TABLET;ORAL	021144-001	Apr 1, 2004	5,635,485	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Injection	5 mg/mL, 40 mL vial	➤ Subscribe	2011-03-23

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0281459	35/1998	Austria	⤷ Try a Trial	PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715
1381356	CA 2014 00005	Denmark	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
2768484	19C1063	France	⤷ Try a Trial	PRODUCT NAME: COMBINAISON DE DAUNORUBICINE ET CYTARABINE; REGISTRATION NO/DATE: EU/1/18/1308 20180827
1667986	PA2013010	Lithuania	⤷ Try a Trial	PRODUCT NAME: CABAZITAXELUM; REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1381356	PA2014004	Lithuania	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
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
2344130	132017000093887	Italy	⤷ Try a Trial	PRODUCT NAME: OZENOXACIN(DUBINE); AUTHORISATION NUMBER(S) AND DATE(S): ES/H/414/01/DC, 20170519;045237017, 20170711
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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