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	PROGRAF	tacrolimus	FOR SUSPENSION;ORAL	210115-001	May 24, 2018		RX	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Astellas	ADENOCARD	adenosine	INJECTABLE;INJECTION	019937-002	Oct 30, 1989		DISCN	Yes	No		⤷ Try a Trial				⤷ Try a Trial
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes	6,812,238*PED	⤷ Try a Trial			Y	⤷ Try a Trial
Astellas	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-001	Nov 19, 2004	AB	RX	Yes	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	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,655,637	⤷ Try a Trial
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	6,265,536	⤷ Try a Trial
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,440,458	⤷ Try a Trial
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	6,884,433	⤷ Try a Trial
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	6,884,433	⤷ Try a Trial
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	7,144,872	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	SPC/GB20/007	United Kingdom	⤷ Try a Trial	PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTERED: UK EU/1/19/1399(FOR NI) 20191028; UK PLGB00166/0425 20191028
2428508	PA2020002	Lithuania	⤷ Try a Trial	PRODUCT NAME: GILTERITINIBAS; REGISTRATION NO/DATE: EU/1/19/1399 20191024
1893196	122013000155	Germany	⤷ Try a Trial	PRODUCT NAME: ENZALUTAMID ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIERVON; REGISTRATION NO/DATE: EU/1/13/846 20130621
2428508	CA 2020 00006	Denmark	⤷ Try a Trial	PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
1280795	CR 2016 00002	Denmark	⤷ Try a 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; REG. NO/DATE: EU/1/15/1036 20151019
1893196	C 2013 041	Romania	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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