Astellas Company Profile

What is the competitive landscape for ASTELLAS

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 sixty-seven patent family members on ASTELLAS drugs in forty-three countries and eighty-one supplementary protection certificates in twenty countries.

Summary for Astellas

International Patents:	467
US Patents:	31
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	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020	AB	RX	Yes	No	11,839,689		Y
Astellas	ARISTOCORT A	triamcinolone acetonide	CREAM;TOPICAL	083015-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	AB	RX	Yes	No
Astellas	ARISTOCORT A	triamcinolone acetonide	OINTMENT;TOPICAL	080750-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	AP	RX	Yes	Yes	8,106,183			Y

Expired US Patents for Astellas

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	6,642,210
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,133,879
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	6,576,259
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023	7,803,931
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020	9,126,941

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
Taiwan	I673051
Hong Kong	1214816
Japan	2022101657
Spain	2667706
Israel	278018

Supplementary Protection Certificates for Astellas Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2428508	8/2020	Austria		PRODUCT NAME: GILTERITINIB ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1399 (MITTEILUNG) 20191028
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
2948455	202440015	Slovenia		PRODUCT NAME: FEZOLINETANT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1771/001-003; DATE OF NATIONAL AUTHORISATION: 20231207; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2428508	CR 2020 00006	Denmark		PRODUCT NAME: GILTERITINIB ELLER ET SALT DERAF; REG. NO/DATE: EU/1/19/1399 20191028
2948455	C202430026	Spain		PRODUCT NAME: FEZOLINETANT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1771; DATE OF AUTHORISATION: 20231207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1771; DATE OF FIRST AUTHORISATION IN EEA: 20231207

Similar Applicant Names

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

• Astellas