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Daiichi Sankyo Company Profile

DAIICHI SANKYO has thirteen approved drugs.

There are fourteen US patents protecting DAIICHI SANKYO drugs.

There are two hundred and sixty-one patent family members on DAIICHI SANKYO drugs in forty-three countries and forty-seven supplementary protection certificates in fourteen countries.

International Patents:	261
US Patents:	14
Tradenames:	10
Ingredients:	10
NDAs:	13
Patent Litigation for Daiichi Sankyo:	See patent lawsuits for Daiichi Sankyo
PTAB Cases with Daiichi Sankyo as patent owner:	See PTAB cases with Daiichi Sankyo as patent owner

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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
Daiichi Sankyo Inc	TURALIO	pexidartinib hydrochloride	CAPSULE;ORAL	211810-001	Aug 2, 2019		RX	Yes	Yes	8,722,702	See Pricing		Y		See Pricing
Daiichi Sankyo	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-002	Oct 2, 2009	AB	RX	Yes	Yes	7,229,613*PED	See Pricing			Y	See Pricing
Daiichi Sankyo Inc	ROXYBOND	oxycodone hydrochloride	TABLET;ORAL	209777-001	Apr 20, 2017		DISCN	No	No		See Pricing				See Pricing
Daiichi Sankyo	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-001	Jul 23, 2010	AB	RX	Yes	No		See Pricing				See Pricing
Daiichi Sankyo Inc	MORPHABOND ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	206544-004	Oct 2, 2015		RX	Yes	Yes	7,955,619	See Pricing	Y			See Pricing
Daiichi Sankyo	TRIBENZOR	amlodipine besylate; hydrochlorothiazide; olmesartan medoxomil	TABLET;ORAL	200175-003	Jul 23, 2010	AB	RX	Yes	No		See Pricing				See Pricing
>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
Daiichi Sankyo	AZOR	amlodipine besylate; olmesartan medoxomil	TABLET;ORAL	022100-002	Sep 26, 2007	5,616,599*PED	See Pricing
Daiichi Sankyo	WELCHOL	colesevelam hydrochloride	CAPSULE;ORAL	021141-001	May 26, 2000	5,917,007*PED	See Pricing
Daiichi Sankyo	BENICAR	olmesartan medoxomil	TABLET;ORAL	021286-001	Apr 25, 2002	5,616,599*PED	See Pricing
Daiichi Sankyo	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	7,101,960*PED	See Pricing
Daiichi Sankyo	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	6,433,026*PED	See Pricing
Daiichi Sankyo	WELCHOL	colesevelam hydrochloride	FOR SUSPENSION;ORAL	022362-001	Oct 2, 2009	5,919,832*PED	See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	625 mg	➤ Subscribe	2009-07-01
➤ Subscribe	Tablets	5 mg/20 mg and 10 mg/40 mg	➤ Subscribe	2008-02-11
➤ Subscribe	Tablets	5 mg, 20 mg and 40 mg	➤ Subscribe	2006-04-25
➤ Subscribe	Tablets	40 mg/12.5 mg and 40 mg/25 mL	➤ Subscribe	2007-02-15
➤ Subscribe	Tablets	15 mg, 30 mg, 60 mg and 100 mg	➤ Subscribe	2019-01-28
➤ Subscribe	Powder for Oral Suspension	1.875 g/Packet and 3.75 g/Packet	➤ Subscribe	2010-04-09
➤ Subscribe	Tablets	10 mg/20 mg and 5 mg/40 mg	➤ Subscribe	2008-03-31
➤ Subscribe	Tablets	20 mg/12.5 mg	➤ Subscribe	2007-05-11
➤ Subscribe	Capsules	30 mg	➤ Subscribe	2009-02-27
➤ Subscribe	Tablets	15 mg, 30 mg and 60 mg	➤ Subscribe	2019-01-28

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Country	Patent Number	Estimated Expiration
Brazil	PI0721137	See Pricing
European Patent Office	1379259	See Pricing
Hong Kong	1133649	See Pricing
World Intellectual Property Organization (WIPO)	2016179415	See Pricing
South Korea	100863113	See Pricing
Austria	380553	See Pricing
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1405852	CA 2015 00052	Denmark	See Pricing	PRODUCT NAME: EDOXABAN, HERUNDER EDOXABAN TOSILATE; REG. NO/DATE: EU/1/15/993/001-028 20150623
0443983	2007C/043	Belgium	See Pricing	PRODUCT NAME: AMLODIPINE ET VALSARTAN; NATL. REGISTRATION NO/DATE: EU/1/06/370/001 20070118; FIRST REGISTRATION: CH 57771 20061222
2140867	PA2018005	Lithuania	See Pricing	PRODUCT NAME: EDOKSABANAS, JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, ARBA BET KURIO IS JU HIDRATAS, YPAC EDOKSABANO P-TOLUENSULFONATO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/15/993/001-028 20150619
0503785	CA 2009 00015	Denmark	See Pricing	PRODUCT NAME: EN KOMBINATION AF OLMESARTANMEDOXOMIL, EVT. I FORM AF ET FARMACEUTISK ACCEPTABELT SALT OG AMLODIPIN-BESILAT; NAT. REG. NO/DATE: MT 42061, 42062, 42063 20081120; FIRST REG. NO/DATE: NL RVG 100984 20080819
1405852	CR 2015 00052	Denmark	See Pricing	PRODUCT NAME: EDOXABAN, OR A SALT THEREOF, A SOLVATE THEREOF, OR AN N-OXIDE THEREOF, IN PARTICULAR EDOXABAN TOSYLATE; REG. NO/DATE: EU/1/15/993/001-028 20150623
0503785	CA 2011 00026	Denmark	See Pricing	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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