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Last Updated: January 23, 2020

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LEXISCAN Drug Profile

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Which patents cover Lexiscan, and when can generic versions of Lexiscan launch?

Lexiscan is a drug marketed by Astellas and is included in one NDA. There are seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-seven patent family members in twenty-seven countries.

The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the regadenoson profile page.

US ANDA Litigation and Generic Entry Outlook for Lexiscan

Lexiscan was eligible for patent challenges on April 10, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 2, 2027. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for LEXISCAN
Drug Prices for LEXISCAN

See drug prices for LEXISCAN

Generic Entry Opportunity Date for LEXISCAN
Generic Entry Date for LEXISCAN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LEXISCAN

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

SponsorPhase
Paul KimPhase 4
Christine Lau, MDPhase 1
Astellas Pharma US, Inc.Phase 2

See all LEXISCAN clinical trials

Recent Litigation for LEXISCAN

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 LEXISCAN litigation

Pharmacology for LEXISCAN
Synonyms for LEXISCAN
(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 (TN)
LS-193008
LZPZPHGJDAGEJZ-AKAIJSEGSA-N
MolPort-006-170-140
NCGC00249892-01
Rapiscan
Regadenoson
Regadenoson (USAN/INN)
Regadenoson [USAN:INN]
Regadenoson anhydrous
Regadenoson; CVT-3146
SCHEMBL678893
Tox21_113668
UNII-7AXV542LZ4
ZINC13818943
Paragraph IV (Patent) Challenges for LEXISCAN
Tradename Dosage Ingredient NDA Submissiondate
LEXISCAN SOLUTION;INTRAVENOUS regadenoson 022161 2012-04-10

US Patents and Regulatory Information for LEXISCAN

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

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
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 LEXISCAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1189916 SPC004/2011 Ireland   Start Trial SPC004/2011: 20110719, EXPIRES: 20250620
1189916 CA 2011 00005 Denmark   Start Trial PRODUCT NAME: REGADENOSON OG SALTE DERAF
1189916 11C0004 France   Start Trial PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 SPC/GB11/005 United Kingdom   Start Trial PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906
1189916 1190003-2.L Sweden   Start Trial PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
1189916 2/2011 Austria   Start Trial PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 392 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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