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

There are four hundred and thirty-five patent family members on ASTELLAS drugs in forty-two countries and sixty-five supplementary protection certificates in nineteen countries.

Summary for Astellas

International Patents:	435
US Patents:	30
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	XOSPATA	gilteritinib fumarate	TABLET;ORAL	211349-001	Nov 28, 2018		RX	Yes	Yes	10,786,500		Y
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015		RX	Yes	Yes
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-002	Nov 22, 2022		RX	Yes	No
Astellas	CEFIZOX	ceftizoxime sodium	INJECTABLE;INJECTION	050560-003	Sep 15, 1983		DISCN	No	No
Astellas	CEFIZOX IN PLASTIC CONTAINER	ceftizoxime sodium	INJECTABLE;INJECTION	050589-004	Apr 13, 1995		DISCN	No	No

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	7,582,617
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008	8,470,801
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013	6,576,259
Astellas	CRESEMBA	isavuconazonium sulfate	CAPSULE;ORAL	207500-001	Mar 6, 2015	7,459,561
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	6,884,433
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995	5,070,877

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
South Korea	101878888
China	101155822
China	101460467
Brazil	112016000546
Mexico	2008012492
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
1893196	C300632	Netherlands		PRODUCT NAME: ENZALUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/846 20130621
2428508	132020000000016	Italy		PRODUCT NAME: GILTERITINIB E SUOI SALI(XOSPATA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1399, 20191028
1893196	CA 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1280795	122014000122	Germany		PRODUCT NAME: SITAGLIPTIN IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
0801067	SPC/GB04/029	United Kingdom		PRODUCT NAME: SOLIFENACIN AND/OR PHARMACEUTICALLY ACTIVE SALT THEREOF; REGISTERED: NL RVG 29151 20031216; NL RVG 29152 20031216; UK PL 00166/0197 20040816; UK PL 0016/0198 20040816

Similar Applicant Names

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

• Astellas