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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-three patent family members on ASTELLAS drugs in thirty-nine countries and sixty-three supplementary protection certificates in eighteen countries.

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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	TABLET;ORAL	011161-010	Approved Prior to Jan 1, 1982		DISCN	No	No		Start Trial				Start Trial
Astellas	ARISTOCORT	triamcinolone diacetate	SYRUP;ORAL	011960-004	Approved Prior to Jan 1, 1982		DISCN	No	No		Start Trial				Start Trial
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	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	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	8,536,150	Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,655,636	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Extended-release Capsules	0.5 mg, 1 mg, and 5 mg	➤ Subscribe	2013-11-15

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010128659	Start Trial
Spain	2667706	Start Trial
Israel	243812	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	2020C/502	Belgium	Start Trial	PRODUCT NAME: GILTERITINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028
0801067	04C0032	France	Start Trial	PRODUCT NAME: SUCCINATE DE SOLIFENACINE; NAT. REGISTRATION NO/DATE: NL 30 109 20040816; FIRST REGISTRATION: NL - RVG 29 151 20031216
1189916	392	Finland	Start Trial
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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