Astellas Company Profile

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ASTELLAS has thirty-seven approved drugs.

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

There are four hundred and thirty-seven patent family members on ASTELLAS drugs in forty-two countries and sixty-five supplementary protection certificates in nineteen countries.

International Patents:	437
US Patents:	31
Tradenames:	21
Ingredients:	16
NDAs:	37
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	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes	6,812,238*PED	⤷ Sign Up			Y	⤷ Sign Up
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004	AB	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Astellas	ARISTOCORT	triamcinolone	TABLET;ORAL	011161-004	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Astellas	ARISTOGEL	triamcinolone acetonide	GEL;TOPICAL	083380-001	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-002	Apr 8, 1994	AB	RX	Yes	Yes		⤷ 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	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	6,403,567	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,536,150	⤷ Sign Up
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	6,884,433	⤷ Sign Up
Astellas	PROGRAF	tacrolimus	INJECTABLE;INJECTION	050709-001	Apr 8, 1994	5,260,301	⤷ Sign Up
Astellas	ADENOCARD	adenosine	INJECTABLE;INJECTION	019937-002	Oct 30, 1989	4,673,563	⤷ Sign Up
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	6,265,536	⤷ Sign Up
>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)	2007127010	⤷ Sign Up
Australia	2835201	⤷ Sign Up
European Patent Office	3020706	⤷ Sign Up
China	102905706	⤷ Sign Up
China	105358535	⤷ Sign Up
Mexico	2012013328	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	92338	Luxembourg	⤷ Sign Up	PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
2428508	2090007-2	Sweden	⤷ Sign Up	PRODUCT NAME: GILTERITINIB OR A SALT THEROF; REG. NO/DATE: EU/1/19/1399 20191028
1280795	SPC/GB15/078	United Kingdom	⤷ 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; REGISTERED: UK EU/1/15/1036 20151019
2428508	301028	Netherlands	⤷ Sign Up	PRODUCT NAME: GILTERITINIB OF EEN ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/19/13177 20191028
1893196	C 2013 041	Romania	⤷ Sign Up	PRODUCT NAME: ENZALUTAMIDA SAU O SARE ACCEPTABILA FARMACEUTIC AACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/846; DATE OF NATIONAL AUTHORISATION: 20130621; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/846; DATE OF FIRST AUTHORISATION IN EEA: 20130621
1893196	122013000155	Germany	⤷ Sign Up	PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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