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Astellas Company Profile

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ASTELLAS has thirty-three approved drugs.

There are thirty-one US patents protecting ASTELLAS drugs.

There are four hundred and ten patent family members on ASTELLAS drugs in forty-three countries and fifty-six supplementary protection certificates in sixteen countries.

International Patents:	410
US Patents:	31
Tradenames:	18
Ingredients:	14
NDAs:	33
Patent Litigation for Astellas:	See patent lawsuits for Astellas

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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
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	7,709,517	Start Trial	Y	Y		Start Trial
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	AP	RX	Yes	Yes	6,774,104*PED	Start Trial			Y	Start Trial
Astellas	ARISTOCORT	triamcinolone diacetate	SYRUP;ORAL	011960-004	Approved Prior to Jan 1, 1982		DISCN	No	No		Start Trial				Start Trial
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004	AB	RX	Yes	Yes	6,017,927*PED	Start Trial				Start Trial
Astellas	CEFIZOX	ceftizoxime sodium	INJECTABLE;INJECTION	050560-005	Mar 19, 1993		DISCN	No	No		Start Trial				Start 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
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004	6,017,927*PED	Start Trial
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	5,965,156	Start Trial
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	6,440,458	Start Trial
Astellas	CYCLOCORT	amcinonide	OINTMENT;TOPICAL	018498-001	Approved Prior to Jan 1, 1982	4,158,055	Start Trial
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,440,458	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Extended-release Capsules	0.5 mg, 1 mg, and 5 mg	➤ Subscribe	2013-11-15
➤ Subscribe	For Injection	50 mg/vial and 100 mg/vial	➤ Subscribe	2014-06-16
➤ Subscribe	Injection	3 mg/mL, 20 mL and 30 mL vials	➤ Subscribe	2005-04-16
➤ Subscribe	Tablets	5 mg and 10 mg	➤ Subscribe	2009-04-08
➤ Subscribe	Capsules	40 mg	➤ Subscribe	2016-08-31
➤ Subscribe	Injection	3 mg/mL, 20 mL and 30 mL vials	➤ Subscribe	2005-04-18
➤ Subscribe	Injection	0.08 mg/mL, 5 mL vial	➤ Subscribe	2012-04-10

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0801067	SPC014/2004	Ireland	Start Trial	SPC014/2004: 20050803, EXPIRES: 20181215
1189916	C01189916/01	Switzerland	Start Trial	PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1280795	92939	Luxembourg	Start Trial	PRODUCT NAME: ISAVUCONBAZOLE EN TANT QUE SULFATE D'ISAVUCONAZONIUM OU EN TANT QUE SEL D'ISAVUCONAZONIUM AVEC TOUT AUTRE ANION PHARMACEUTIQUEMENT ACCEPTABLE, OPTIONNELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151019
1893196	SPC/GB13/079	United Kingdom	Start Trial	PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1189916	1190003-2.L	Sweden	Start Trial	PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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