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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-seven patent family members in twenty-seven countries.

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

Summary for regadenoson

International Patents:	87
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	43
Clinical Trials:	53
Patent Applications:	84
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for regadenoson
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

DB06213

DSSTox_CID_31501

DSSTox_GSID_57712

DSSTox_RID_97386

DTXSID4057712

EX-A2148

FT-0674337

GTPL5596

HY-A0168

J-018384

Lexiscan

Lexiscan (TN)

LS-193008

LZPZPHGJDAGEJZ-AKAIJSEGSA-N

MolPort-006-170-140

NCGC00249892-01

Rapiscan

Regadenoson (USAN/INN)

Regadenoson [USAN:INN]

Regadenoson anhydrous

Regadenoson; CVT-3146

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			Y
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
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

International Patents for regadenoson

Country	Patent Number	Estimated Expiration
Brazil	0011856
Denmark	1189916
Hong Kong	1044952
South Korea	20130130868

Supplementary Protection Certificates for regadenoson

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1189916	1190003-2.L	Sweden		PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
1189916	SPC/GB11/005	United Kingdom		PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906
1189916	SZ 2/2011	Austria		PRODUCT NAME: REGADENOSON UND DESSEN SALZE
1189916	392	Finland