Astellas Company Profile

What is the competitive landscape for ASTELLAS, and when can generic versions of ASTELLAS drugs launch?

ASTELLAS has thirty-five approved drugs.

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

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

Summary for Astellas

International Patents:	283
US Patents:	13
Tradenames:	19
Ingredients:	14
NDAs:	35
Patent Litigation for Astellas:	See patent lawsuits for Astellas

Drugs and US Patents for Astellas

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	210115-002	May 24, 2018		RX	Yes	Yes
Astellas	ARISTOCORT A	triamcinolone acetonide	CREAM;TOPICAL	083015-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Astellas	VESICARE LS	solifenacin succinate	SUSPENSION;ORAL	209529-001	May 26, 2020		RX	Yes	Yes	9,918,970		Y
Astellas	ARISTOCORT	triamcinolone	TABLET;ORAL	011161-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708-001	Apr 8, 1994	AB	RX	Yes	No
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	AP	RX	Yes	Yes

Expired US Patents for Astellas

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	5,874,104
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	6,440,458
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	6,107,458
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	6,403,567
Astellas	VESICARE	solifenacin succinate	TABLET;ORAL	021518-001	Nov 19, 2004	6,017,927*PED
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	6,440,458

Paragraph IV (Patent) Challenges for ASTELLAS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	40 mg		2016-08-31
	Injection	3 mg/mL, 20 mL and 30 mL vials		2005-04-18
	Injection	0.08 mg/mL, 5 mL vial		2012-04-10
	Extended-release Capsules	0.5 mg, 1 mg, and 5 mg		2013-11-15
	For Injection	50 mg/vial and 100 mg/vial		2014-06-16
	Injection	3 mg/mL, 20 mL and 30 mL vials		2005-04-16
	Tablets	5 mg and 10 mg		2009-04-08

International Patents for Astellas Drugs

Country	Patent Number	Estimated Expiration
Philippines	12017502252
South Korea	101332889
Japan	WO2010128659
Japan	2016183200
Denmark	3009428
Norway	20076401

Supplementary Protection Certificates for Astellas Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	2011C/004	Belgium		PRODUCT NAME: REGADENOSON; AUTHORISATION NUMBER AND DATE: EU/1/10/643/001 20100906
1280795	122016000011	Germany		PRODUCT NAME: ISAVUCONAZONIUM ALS ISAVUCONAZONIUM-SULFAT ODER ALS SALZ MIT EINEM ANDEREN PHARMAZEUTISCH VERTRAEGLICHEN ANION, SOWIE HYDRATE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/15/1036 20151015
1893196	92338	Luxembourg		PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
1189916	2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1893196	1390060-0	Sweden		PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621
2428508	C202030004	Spain		PRODUCT NAME: GILTERITINIB O UNA SAL DEL MISMO NOMBRE; NATIONAL AUTHORISATION NUMBER: EU/1/19/1399; DATE OF AUTHORISATION: 20191024; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1399; DATE OF FIRST AUTHORISATION IN EEA: 20191024

Similar Applicant Names

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

• Astellas