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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 regadenoson freedom to operate?

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

Regadenoson has eighty-five patent family members in twenty-six countries.

There are nine drug master file entries for regadenoson. One supplier is listed for this compound.

Summary for regadenoson

International Patents:	85
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	38
Clinical Trials:	52
Patent Applications:	82
DailyMed Link:	regadenoson at DailyMed

Pharmacology for regadenoson

Drug Class	Adenosine Receptor Agonist
Mechanism of Action	Adenosine Receptor Agonists

Synonyms for regadenoson

(1-(9-(3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl)-6-aminopurin-2-yl)pyrazol-4-yl)-N-methylcarboxamide

(1-{9-[(4s,2r,3r,5r)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopurin-2-yl}pyrazol-4-yl)-n-methylcarboxamide

1-(6-Amino-9-beta-D-ribofuranosyl-9H-purin-2-yl)-N-methyl-1H-pyrazole-4-carboxamide

1-[6-Amino-9-((2R,3R,4S,5R)-3,4-dihydroxy-5-hydroxymethyl-tetrahydro-furan-2-yl)-9H-purin-2-yl]-1H-pyrazole-4-carboxylic acid methylamide

1-[6-amino-9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]purin-2-yl]-N-methylpyrazole-4-carboxamide

1-[6-amino-9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl]purin-2-yl]-N-methyl-pyrazole-4-carboxamide

1-{6-amino-9-[(2R,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-9H-purin-2-yl}-N-methyl-1H-pyrazole-4-carboxamide

2-[4-(methylcarbamoyl)-1h-pyrazol-1-yl]adenosine

2-[4-[(Methylamino)carbonyl]-1H-pyrazol-1-yl]adenosine

313348-27-5

348R275

6-Amino-2-[4-(methylcarbamoyl)-1H-pyrazol-1-yl]purine-9-yl-beta-D-ribofuranoside;1-(6-amino-9-((2S,3R,4S,5R)-3,4-dihydroxy-5-(hydroxymethyl)-tetrahydrofuran-2-yloxy)-9H-purin-2-yl)-N-methyl-1H-pyrazole-4-carboxamide

7AXV542LZ4

AC1L55X1

AC1Q5LB1

Adenosine, 2-(4-((methylamino)carbonyl)-1H-pyrazol-1-yl)-

Adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-

Adenosine,2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-

AKOS026750593

AOB6869

API0000807

AT-36942

B5904

BDBM50119132

CAS-313348-27-5

CHEBI:135613

CHEMBL317052

CS-5612

CTK4G6871

CV-3146

CVT 3146

CVT-3146

CVT-3146;CVT3146;CVT 3146

D05711

D0XE1C

DB06213

DSSTox_CID_31501

DSSTox_GSID_57712

DSSTox_RID_97386

DTXSID4057712

FT-0674337

GTPL5596

HY-A0168

J-018384

Lexiscan

Lexiscan (TN)

LS-193008

LZPZPHGJDAGEJZ-AKAIJSEGSA-N

MolPort-006-170-140

NCGC00249892-01

NU001889

NU007666

Rapiscan

Regadenoson (USAN/INN)

Regadenoson [USAN:INN]

Regadenoson anhydrous

SCHEMBL678893

Tox21_113668

UNII-7AXV542LZ4

ZINC13818943

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
Astellas	LEXISCAN	regadenoson	SOLUTION;INTRAVENOUS	022161-001	Apr 10, 2008		RX	Yes	Yes
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	Y

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Non-Orange Book US Patents for regadenoson

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
8,278,435	N-pyrazole A2A receptor agonists
8,569,260	N-pyrazole A.sub.2A receptor agonists
8,071,566	Methods of coronary imaging
9,163,057	Methods of myocardial perfusion imaging

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International Patents for regadenoson

Country	Document Number	Estimated Expiration
Mexico	2010014060
World Intellectual Property Organization (WIPO)	2006044856
Japan	4727880
Japan	2013010791

Supplementary Protection Certificates for regadenoson

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE
2011000010	Germany		PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
785	Luxembourg		91785, EXPIRES: 20250621
2011 00005	Denmark		PRODUCT NAME: REGADENOSON OG SALTE DERAF