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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-two 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:	32
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	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096-002	Jul 19, 2013		RX	Yes	No	6,440,458		Y
Astellas	CEFIZOX	ceftizoxime sodium	INJECTABLE;INJECTION	050560-001	Sep 15, 1983		DISCN	No	No
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes	7,183,264		Y
Astellas	CEFIZOX	ceftizoxime sodium	INJECTABLE;INJECTION	050560-002	Sep 15, 1983		DISCN	No	No

Expired US Patents for Astellas

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	PROGRAF	tacrolimus	INJECTABLE;INJECTION	050709-001	Apr 8, 1994	5,260,301
Astellas	ADENOSCAN	adenosine	SOLUTION;INTRAVENOUS	020059-001	May 18, 1995	5,070,877
Astellas	MYCAMINE	micafungin sodium	INJECTABLE;INTRAVENOUS	021506-002	Mar 16, 2005	5,376,634
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
8,906,878	Myocardial perfusion imaging methods and compositions
7,671,192	Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs
9,163,057	Methods of myocardial perfusion imaging
6,174,896	Quinuclidine derivatives and medicinal composition thereof

International Patents for Astellas Drugs

Country	Document Number	Estimated Expiration
Australia	2007245022
Luxembourg	92939
Czech Republic	295720
Israel	147198

Supplementary Protection Certificates for Astellas Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00477	Netherlands		PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
2	Finland
2011000010	Germany		PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
C014/2004	Ireland		SPC014/2004: 20050803, EXPIRES: 20181215

Similar Applicant Names

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

• Astellas