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Last Updated: December 4, 2020

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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in twenty-six 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 four 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

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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
University of Maryland, BaltimoreEarly Phase 1
National Heart, Lung, and Blood Institute (NHLBI)Early Phase 1
Siemens Medical SolutionsN/A

See all LEXISCAN clinical trials

Pharmacology for LEXISCAN
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   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
>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
>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 SZ 2/2011 Austria   Start Trial PRODUCT NAME: REGADENOSON UND DESSEN SALZE
1189916 122011000010 Germany   Start Trial PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/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 SPC004/2011 Ireland   Start Trial SPC004/2011: 20110719, EXPIRES: 20250620
1189916 CA 2011 00005 Denmark   Start Trial PRODUCT NAME: REGADENOSON OG SALTE DERAF
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Moodys
Medtronic
Merck
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.