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Astellas Company Profile

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What is the competitive landscape for ASTELLAS, and what generic alternatives to ASTELLAS drugs are available?

ASTELLAS has thirty-one approved drugs.

There are twenty-nine US patents protecting ASTELLAS drugs.

There are three hundred and sixty-six patent family members on ASTELLAS drugs in forty countries and forty-seven supplementary protection certificates in fourteen countries.

Summary for Astellas

International Patents:	366
US Patents:	29
Tradenames:	17
Ingredients:	13
NDAs:	31
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	MYCAMINE	micafungin sodium	INJECTABLE;IV (INFUSION)	021506-002	Mar 16, 2005		RX	Yes	Yes	6,107,458		Y	Y
Astellas	CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER	ceftizoxime sodium	INJECTABLE;INJECTION	050589-001	Oct 3, 1984		DISCN	No	No
Astellas	CEFIZOX IN PLASTIC CONTAINER	ceftizoxime sodium	INJECTABLE;INJECTION	050589-004	Apr 13, 1995		DISCN	No	No
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-003	Jul 19, 2013		RX	Yes	Yes	6,440,458		Y

Expired US Patents for Astellas

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	ADENOSCAN	adenosine	SOLUTION;IV (INFUSION)	020059-001	May 18, 1995	5,070,877
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;IV (INFUSION)	021506-002	Mar 16, 2005	6,265,536
Astellas	AMBISOME	amphotericin b	INJECTABLE, LIPOSOMAL;INJECTION	050740-001	Aug 11, 1997	5,965,156
Astellas	CYCLOCORT	amcinonide	CREAM;TOPICAL	018116-002	Approved Prior to Jan 1, 1982	4,158,055

Paragraph IV (Patent) Challenges for ASTELLAS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Capsules	40 mg		2016-08-31
	Tablets	5 mg and 10 mg		2009-04-08
	Injection	3 mg/mL, 20 mL and 30 mL vials		2005-04-16
	For Injection	50 mg/vial and 100 mg/vial		2014-06-16

Non-Orange Book US Patents for Astellas

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,671,192	Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs
7,112,565	Stabilized pharmaceutical composition in lyophilized form
8,278,435	N-pyrazole A2A receptor agonists
6,174,896	Quinuclidine derivatives and medicinal composition thereof

International Patents for Astellas Drugs

Country	Document Number	Estimated Expiration
Germany	122008000025
Portugal	1280795
Israel	243812
European Patent Office	2581381

Supplementary Protection Certificates for Astellas Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
15/073	Ireland		PRODUCT NAME: ISAVUCONAZOLE AS ISAVUCONAZONIUM SULFATE OR AS ISAVUCONAZONIUM SALT WITH ANY OTHER PHARMACEUTICALLY ACCEPTABLE ANION, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, OR SOLVATE; REGISTRATION NO/DATE: EU/1/15/1036 20151015
C004/2011	Ireland		SPC004/2011: 20110719, EXPIRES: 20250620
2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
0352	Netherlands		300352, 20150929, EXPIRES: 20200928

Similar Applicant Names

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

• Astellas