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Last Updated: January 27, 2020

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Regadenoson - Generic Drug Details

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What are the generic 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 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. Two suppliers are listed for this compound.

Recent Clinical Trials for regadenoson

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SponsorPhase
National Cancer Institute (NCI)Phase 1
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 1
Paul KimPhase 4

See all regadenoson clinical trials

Recent Litigation for regadenoson

Identify potential future generic entrants

District Court Litigation
Case NameDate
Astellas US LLC v. Accord Healthcare, Inc.2019-06-25
Astellas US LLC v. Sandoz Inc.2018-10-25

See all regadenoson litigation

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

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

Supplementary Protection Certificates for regadenoson

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1189916 2011C/004 Belgium   Start Trial PRODUCT NAME: REGADENOSON; AUTHORISATION NUMBER AND DATE: EU/1/10/643/001 20100906
1189916 11C0004 France   Start Trial PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 CA 2011 00005 Denmark   Start Trial PRODUCT NAME: REGADENOSON OG SALTE DERAF
1189916 SPC004/2011 Ireland   Start Trial SPC004/2011: 20110719, EXPIRES: 20250620
1189916 C01189916/01 Switzerland   Start Trial PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Moodys
McKinsey
Mallinckrodt
Colorcon

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