Astellas Company Profile

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

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.

Summary for Astellas

International Patents:	433
US Patents:	25
Tradenames:	21
Ingredients:	16
NDAs:	37
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	ARISTOCORT A	triamcinolone acetonide	CREAM;TOPICAL	088819-001	Oct 16, 1984		DISCN	No	No
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Astellas	ARISTOCORT	triamcinolone	TABLET;ORAL	011161-011	Approved Prior to Jan 1, 1982		DISCN	No	No
Astellas	ARISTOCORT A	triamcinolone acetonide	CREAM;TOPICAL	083016-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes	8,183,274
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015		RX	Yes	Yes	6,812,238*PED				Y

Expired US Patents for Astellas

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	6,884,433
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-001	Jul 19, 2013	8,551,522
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	9,045,519
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995	5,070,877
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

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
Spain	2674129
Japan	5822911
South Korea	20210136161
Taiwan	201105326
South Korea	102020721
Taiwan	I756177

Supplementary Protection Certificates for Astellas Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	CR 2020 00006	Denmark		PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
2428508	2020001	Norway		PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAV; REG. NO/DATE: EU/1/19/1399 20191030
1893196	C 2013 041	Romania		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
2428508	PA2020002,C2428508	Lithuania		PRODUCT NAME: GILTERITINIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/19/1399 20191024
1893196	92338	Luxembourg		PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
1893196	1390060-0	Sweden		PRODUCT NAME: ENZALUTAMID OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/13/846 20130621

Similar Applicant Names

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

• Astellas