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	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	AP	RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Astellas	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	ceftizoxime sodium	INJECTABLE;INJECTION	050589-002	Oct 3, 1984		DISCN	No	No		⤷ Sign Up				⤷ Sign Up
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes	7,709,517	⤷ Sign Up	Y	Y		⤷ Sign Up
Astellas	ARISTOCORT	triamcinolone	TABLET;ORAL	011161-010	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ 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	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	6,265,536	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	9,045,519	⤷ Sign Up
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015	7,459,561	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,144,872	⤷ Sign Up
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,655,636	⤷ Sign Up
Astellas	CYCLOCORT	amcinonide	OINTMENT;TOPICAL	018498-001	Approved Prior to Jan 1, 1982	4,158,055	⤷ Sign Up
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	8,551,522	⤷ Sign Up
>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
2428508	LUC00147	Luxembourg	⤷ Sign Up	PRODUCT NAME: GILTERITINIB OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028
1893196	2013/061	Ireland	⤷ Sign Up	PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196	122013000155	Germany	⤷ Sign Up	PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
1893196	491	Finland	⤷ Sign Up
2428508	2020C/502	Belgium	⤷ Sign Up	PRODUCT NAME: GILTERITINIB OF EEN ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1399 20191028
1280795	5/2016	Austria	⤷ Sign Up	PRODUCT NAME: ISAVUCONAZOL ALS ISAVUCONAZONIUMSULFAT ODER ALS EIN ISAVUCONAZONIUMSALZ MIT EINEM ANDEREN PHARMAZEUTISCH ANNEHMBAREN ANION, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS; REGISTRATION NO/DATE: EU/1/15/1036 (MITTEILUNG) 20151015
1189916	11C0004	France	⤷ Sign Up	PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.