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Regadenoson - Generic Drug Details

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What are the generic drug sources for regadenoson and what is the scope of patent protection?

Regadenoson is the generic ingredient in one branded drug marketed by Astellas and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Regadenoson has fifty-eight patent family members in twenty-six countries.

There are nine drug master file entries for regadenoson. Two suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for regadenoson

International Patents:	58
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	58
Patent Applications:	1,006
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for regadenoson
What excipients (inactive ingredients) are in regadenoson?	regadenoson excipients list
DailyMed Link:	regadenoson at DailyMed

Recent Clinical Trials for regadenoson

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Maryland, Baltimore	Phase 1/Phase 2
GE Healthcare	Phase 1/Phase 2
Covance	Phase 1/Phase 2

See all regadenoson clinical trials

Generic filers with tentative approvals for REGADENOSON

Applicant	Application No.	Strength	Dosage Form
		0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS
		0.4MG/5ML (0.08MG/ML)	SOLUTION;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for regadenoson

Drug Class	Adenosine Receptor Agonist
Mechanism of Action	Adenosine Receptor Agonists

Paragraph IV (Patent) Challenges for REGADENOSON

Tradename	Dosage	Ingredient	NDA	Submissiondate
LEXISCAN	SOLUTION;INTRAVENOUS	regadenoson	022161	2012-04-10

US Patents and Regulatory Information for regadenoson

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes			Y	Y
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes			Y
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes				Y

Expired US Patents for regadenoson

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008

International Patents for regadenoson

Country	Patent Number	Estimated Expiration
Japan	5326156
Israel	147198
Canada	2640089
South Africa	200200301
China	1167709
Norway	341322

Supplementary Protection Certificates for regadenoson

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	392	Finland
1189916	2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916	C300477	Netherlands		PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916	122011000010	Germany		PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916	SPC004/2011	Ireland		SPC004/2011: 20110719, EXPIRES: 20250620
1189916	SZ 2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE