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 sixty-seven patent family members on ASTELLAS drugs in forty-three countries and eighty-one supplementary protection certificates in twenty countries.

International Patents:	467
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	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020	AB	RX	Yes	No	11,839,689	⤷ Start Trial	Y			⤷ Start Trial
Astellas	ARISTOCORT A	triamcinolone acetonide	CREAM;TOPICAL	083015-003	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	AB	RX	Yes	No		⤷ Start Trial				⤷ Start Trial
Astellas	ARISTOCORT A	triamcinolone acetonide	OINTMENT;TOPICAL	080750-003	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Start Trial				⤷ Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes	8,106,183	⤷ Start Trial		Y		⤷ Start Trial
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		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	6,642,210	⤷ Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,133,879	⤷ Start Trial
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	6,576,259	⤷ Start Trial
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023	7,803,931	⤷ Start Trial
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020	9,126,941	⤷ Start Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	9,045,519	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	8/2020	Austria	⤷ Start Trial	PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 20191028
0788511	SPC/GB08/036	United Kingdom	⤷ Start Trial	PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
2948455	202440015	Slovenia	⤷ Start Trial	PRODUCT NAME: FEZOLINETANT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1771/001-003; DATE OF NATIONAL AUTHORISATION: 20231207; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2428508	CR 2020 00006	Denmark	⤷ Start Trial	PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
2948455	C202430026	Spain	⤷ Start Trial	PRODUCT NAME: FEZOLINETANT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1771; DATE OF AUTHORISATION: 20231207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1771; DATE OF FIRST AUTHORISATION IN EEA: 20231207
1280795	SPC/GB15/078	United Kingdom	⤷ Start Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Here is a list of applicants with similar names.