ASTELLAS Company Profile

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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-two patent family members on ASTELLAS drugs in thirty-seven countries and sixty-seven supplementary protection certificates in nineteen countries.

International Patents:	282
US Patents:	13
Tradenames:	19
Ingredients:	14
NDAs:	35
Patent Litigation for ASTELLAS:	See patent lawsuits for ASTELLAS

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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	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes		See Plans and Pricing				See Plans and Pricing
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	AP	RX	Yes	Yes		See Plans and Pricing				See Plans and Pricing
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No	9,126,941	See Plans and Pricing				See Plans and Pricing
Astellas	CEFIZOX	ceftizoxime sodium	INJECTABLE;INJECTION	050560-003	Sep 15, 1983		DISCN	No	No		See Plans and Pricing				See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	CRESEMBA	isavuconazonium sulfate	POWDER;INTRAVENOUS	207501-001	Mar 6, 2015	7,459,561	See Plans and Pricing
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-003	Jun 27, 2006	6,107,458	See Plans and Pricing
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-002	Approved Prior to Jan 1, 1982	4,158,055	See Plans and Pricing
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013	8,551,522	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	2013/061	Ireland	See Plans and Pricing	PRODUCT NAME: ENZALUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/846 20130625
2428508	2020/004	Ireland	See Plans and Pricing	PRODUCT NAME: GILTERITINIB OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1399 20191024
1893196	SPC/GB13/079	United Kingdom	See Plans and Pricing	PRODUCT NAME: ENZLUTAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/846 20130625
1280795	1690011-0	Sweden	See Plans and Pricing	PRODUCT NAME: ISAVUCONAZOLE; REG. NO/DATE: EU/1/15/1036 20151016
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description