Astellas Company Profile

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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.

Summary for Astellas

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	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No
Astellas	ARISTOCORT A	triamcinolone acetonide	OINTMENT;TOPICAL	080750-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020	AB	RX	Yes	No	12,502,357
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No
Astellas	ARISTOCORT A	triamcinolone acetonide	OINTMENT;TOPICAL	080745-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No

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	204096-002	Jul 19, 2013	6,884,433
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020	9,126,941
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,133,879
Astellas	IZERVAY	avacincaptad pegol sodium	SOLUTION;INTRAVITREAL	217225-001	Aug 4, 2023	7,803,931
Astellas	PROGRAF	tacrolimus	INJECTABLE;INJECTION	050709-001	Apr 8, 1994	5,260,301

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
Hungary	E026647
Russian Federation	2668972
European Patent Office	2068842
China	104404046
Hong Kong	1124612

Supplementary Protection Certificates for Astellas Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1893196	2013C/074	Belgium		PRODUCT NAME: ENZALUTAMIDE (ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/13/846 20130625
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
1893196	CA 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
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

Similar Applicant Names

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

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