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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Covington
US Army
US Department of Justice
Colorcon
Johnson and Johnson
Queensland Health
Teva
UBS

Generated: September 20, 2018

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LEXISCAN Drug Profile

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When do Lexiscan patents expire, 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.

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

Drug patent expirations by year 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.

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
D0XE1C
DB06213
DSSTox_CID_31501
DSSTox_GSID_57712
DSSTox_RID_97386
DTXSID4057712
FT-0674337
GTPL5596
HY-A0168
J-018384
Lexiscan (TN)
LS-193008
LZPZPHGJDAGEJZ-AKAIJSEGSA-N
MolPort-006-170-140
NCGC00249892-01
NU001889
NU007666
Rapiscan
Regadenoson
Regadenoson (USAN/INN)
Regadenoson [USAN:INN]
Regadenoson anhydrous
SCHEMBL678893
Tox21_113668
UNII-7AXV542LZ4
ZINC13818943

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

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Paragraph IV (Patent) Challenges for LEXISCAN
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 0.08 mg/mL, 5 mL vial ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for LEXISCAN

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
8,524,883 Monohydrate of (1-{9-[4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopu- rin-2-yl}pyrazol-4-yl)-N-methylcarboxamide ➤ Try a Free Trial
7,956,179 Process for preparing an A2A-adenosine receptor agonist and its polymorphs ➤ Try a Free Trial
8,278,435 N-pyrazole A2A receptor agonists ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for LEXISCAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011 Austria ➤ Try a Free Trial PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
2011000010 Germany ➤ Try a Free Trial PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
90003-2.L Sweden ➤ Try a Free Trial PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Covington
US Army
US Department of Justice
Colorcon
Johnson and Johnson
Queensland Health
Teva
UBS

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