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Astellas Company Profile

ASTELLAS has thirty-three approved drugs.

There are thirty-one US patents protecting ASTELLAS drugs.

There are four hundred and two patent family members on ASTELLAS drugs in forty-two countries and fifty-four supplementary protection certificates in fifteen countries.

International Patents:	402
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	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006		RX	Yes	Yes	6,774,104	➤ Sign Up	Y			➤ Sign Up
Astellas	ARISTOCORT	triamcinolone diacetate	SYRUP;ORAL	011960-004	Approved Prior to Jan 1, 1982		DISCN	No	No		➤ Sign Up				➤ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes	7,683,037	➤ Sign Up				➤ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes	9,045,519	➤ Sign Up	Y			➤ Sign Up
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004	AB	RX	Yes	Yes	6,017,927*PED	➤ Sign Up				➤ Sign Up
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013		RX	Yes	Yes	8,551,522	➤ Sign Up	Y			➤ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes	7,655,636	➤ Sign Up				➤ Sign Up
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	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,440,458	➤ Sign Up
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	5,965,156	➤ Sign Up
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	6,265,536	➤ Sign Up
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	6,107,458	➤ Sign Up
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995	5,070,877	➤ Sign Up
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	6,884,433	➤ Sign Up
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	6,440,458	➤ Sign Up
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
1189916	1190003-2.L	Sweden	➤ Sign Up	PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
1189916	CA 2011 00005	Denmark	➤ Sign Up	PRODUCT NAME: REGADENOSON OG SALTE DERAF
0788511	08C0028	France	➤ Sign Up	PRODUCT NAME: MICAFUNGINE; REGISTRATION NO/DATE: EU/1/08/448/001-002 20080425
1189916	SPC/GB11/005	United Kingdom	➤ Sign Up	PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906
1893196	CA 2013 00065	Denmark	➤ Sign Up	PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1280795	CA 2016 00002	Denmark	➤ Sign Up	PRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS AN ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REG. NO/DATE: EU/1/15/1036 20151019
1189916	392	Finland	➤ Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

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