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Astellas Company Profile

ASTELLAS has thirty-five approved drugs.

There are twelve US patents protecting ASTELLAS drugs. There is one tentative approval on ASTELLAS drugs.

There are two hundred and eighty-one patent family members on ASTELLAS drugs in thirty-nine countries and sixty supplementary protection certificates in eighteen countries.

International Patents:	281
US Patents:	12
Tradenames:	19
Ingredients:	14
NDAs:	35
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	ARISTOCORT	triamcinolone acetonide	CREAM;TOPICAL	083017-003	Approved Prior to Jan 1, 1982		DISCN	No	No		Start Trial				Start Trial
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529-001	May 26, 2020		RX	Yes	Yes		Start Trial				Start Trial
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997		RX	Yes	Yes		Start Trial				Start Trial
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529-001	May 26, 2020		RX	Yes	Yes		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	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,655,637	Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,470,801	Start Trial
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	6,107,458	Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,133,879	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	PA2013029,C1893196	Lithuania	Start Trial	PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
1280795	2015/073	Ireland	Start Trial	PRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
0801067	C00801067/01	Switzerland	Start Trial	PRODUCT NAME: SOLIFENACIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57203 12.05.2006
1189916	392	Finland	Start Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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