Astellas Company Profile

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ASTELLAS has thirty-seven approved drugs.

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

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

International Patents:	433
US Patents:	25
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	ADENOCARD	adenosine	INJECTABLE;INJECTION	019937-002	Oct 30, 1989		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-002	May 18, 1995		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Astellas	ARISTOCORT A	triamcinolone acetonide	CREAM;TOPICAL	088818-001	Oct 16, 1984		DISCN	No	No		⤷ Try a Trial				⤷ Try a Trial
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	9,126,941	⤷ Try a Trial				⤷ Try a Trial
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-002	Apr 8, 1994	AB	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No	11,839,689	⤷ Try a Trial	Y			⤷ Try a Trial
Astellas	ARISTOCORT	triamcinolone	TABLET;ORAL	011161-007	Approved Prior to Jan 1, 1982		DISCN	No	No		⤷ Try a Trial				⤷ Try a 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	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,440,458	⤷ Try a Trial
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995	5,731,296	⤷ Try a Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	9,289,446	⤷ Try a Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	RE47351	⤷ Try a Trial
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	5,874,104	⤷ Try a Trial
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-002	Nov 19, 2004	6,017,927*PED	⤷ Try a Trial
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995	5,070,877	⤷ Try a 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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Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	201290940	⤷ Try a Trial
Cyprus	1119576	⤷ Try a Trial
China	105037273	⤷ Try a Trial
Canada	2897900	⤷ Try a Trial
New Zealand	572374	⤷ Try a Trial
Japan	5831449	⤷ Try a Trial
Slovenia	3318259	⤷ Try a Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	20C1003	France	⤷ Try a Trial	PRODUCT NAME: GILTERITINIB OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/19/1399 20191028
1893196	2013C/074	Belgium	⤷ Try a Trial	PRODUCT NAME: ENZALUTAMIDE (ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/13/846 20130625
1280795	5/2016	Austria	⤷ Try a Trial	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
2428508	2090007-2	Sweden	⤷ Try a Trial	PRODUCT NAME: GILTERITINIB OR A SALT THEROF; REG. NO/DATE: EU/1/19/1399 20191028
0788511	C00788511/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: MICAFUNGIN; REGISTRATION NO/DATE: SWISSMEDIC 60724 11.07.2012
1893196	1390060-0	Sweden	⤷ Try a Trial	PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621
1893196	CR 2013 00065	Denmark	⤷ Try a Trial	PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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