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Last Updated: July 18, 2024

LEXISCAN Drug Patent 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 two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eighteen countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Lexiscan

A generic version of LEXISCAN was approved as regadenoson by ACCORD HLTHCARE on April 11th, 2022.

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Drug patent expirations by year for LEXISCAN
Drug Prices for LEXISCAN

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Recent Clinical Trials for LEXISCAN

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

SponsorPhase
St. Jude Children's Research HospitalPhase 2
Emory UniversityN/A
Siemens Medical SolutionsN/A

See all LEXISCAN clinical trials

Paragraph IV (Patent) Challenges for LEXISCAN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LEXISCAN Injection regadenoson 0.08 mg/mL, 5 mL vial 022161 1 2012-04-10

US Patents and Regulatory Information for LEXISCAN

LEXISCAN is protected by two US patents.

Patents protecting LEXISCAN

Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Sign Up ⤷  Sign Up
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Sign Up ⤷  Sign Up
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Sign Up ⤷  Sign Up
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for LEXISCAN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GE Healthcare AS  Rapiscan regadenoson EMEA/H/C/001176
This medicinal product is for diagnostic use only.Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.
Authorised no no no 2010-09-06
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for LEXISCAN

When does loss-of-exclusivity occur for LEXISCAN?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 07212542
Patent: Process for preparing an A2A-Adenosine receptor agonist and its polymorphs
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 40089
Patent: PROCEDE DE PREPARATION D'UN AGONISTE DE RECEPTEUR A2A-ADENOSINE ET SES POLYMORPHES (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS)
Estimated Expiration: ⤷  Sign Up

Patent: 87759
Patent: PROCEDE DE PREPARATION D'UN AGONISTE DE RECEPTEUR A2A-ADENOSINE ET SES POLYMORPHES (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1379073
Patent: Process for preparing an a2a-adenosine receptor agonist and its polymorphs
Estimated Expiration: ⤷  Sign Up

Patent: 2260311
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 89214
Patent: PROCEDE DE PREPARATION D'UN AGONISTE DE RECEPTEUR A2A-ADENOSINE ET SES POLYMORPHES (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS)
Estimated Expiration: ⤷  Sign Up

Patent: 81381
Patent: Procédé de préparation d'un agoniste du récepteur A2A-adénosine et ses polymorphes (Process for preparing an A2A-adenosine receptor agonist and its polymorphs)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 27358
Patent: 製備種 型腺苷受體激動劑及其多晶形物的方法 (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS A2A)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3153
Patent: תהליך להכנת אגוניסט לקולטן אדנוזין a2a (Process for preparing an a2a-adenosine receptor agonist)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 26156
Estimated Expiration: ⤷  Sign Up

Patent: 09525347
Estimated Expiration: ⤷  Sign Up

Patent: 13010791
Patent: PROCESS FOR PREPARING A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS
Estimated Expiration: ⤷  Sign Up

Patent: 13014620
Patent: PROCESS FOR PREPARING A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10014060
Patent: PROCESO PARA PREPARAR UN AGONISTA DE RECEPTOR DE ADENOSINA A2A Y SUS POLIMORFAS. (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0239
Patent: Preparation of (1-{ 9-[(4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopurin-2-yl} pyrazol-4-yl)-N-methylcarboxamide monohydrate
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 1322
Estimated Expiration: ⤷  Sign Up

Patent: 083395
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 89214
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 89214
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 47081
Patent: СПОСОБ ПОЛУЧЕНИЯ АГОНИСТА A2A-АДЕНОЗИНОВОГО РЕЦЕПТОРА И ЕГО ПОЛИМОРФОВ (METHOD OF PRODUCING A2A-ADENOSINE RECEPTOR AGONIST AND POLYMORPHS THEREOF)
Estimated Expiration: ⤷  Sign Up

Patent: 08131956
Patent: СПОСОБ ПОЛУЧЕНИЯ АГОНИСТА А2А-АДЕНОЗИНОВОГО РЕЦЕПТОРА И ЕГО ПОЛИМОРФОВ
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 89214
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0806666
Patent: Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1494125
Estimated Expiration: ⤷  Sign Up

Patent: 080090491
Patent: PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS
Estimated Expiration: ⤷  Sign Up

Patent: 130130868
Patent: PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 93028
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LEXISCAN around the world.

Country Patent Number Title Estimated Expiration
Spain 2209974 ⤷  Sign Up
Norway 322457 ⤷  Sign Up
South Korea 20080090491 PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS ⤷  Sign Up
Canada 2439222 PROCEDE PERMETTANT D'IDENTIFIER DES AGONISTES PARTIELS DU RECEPTEUR A2A (IDENTIFICATION OF PARTIAL AGONISTS OF THE A2A ADENOSINE RECEPTOR) ⤷  Sign Up
China 1167709 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LEXISCAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1189916 2/2011 Austria ⤷  Sign Up PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 SPC004/2011 Ireland ⤷  Sign Up SPC004/2011: 20110719, EXPIRES: 20250620
1189916 122011000010 Germany ⤷  Sign Up PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 C01189916/01 Switzerland ⤷  Sign Up PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1189916 2011C/004 Belgium ⤷  Sign Up PRODUCT NAME: REGADENOSON; AUTHORISATION NUMBER AND DATE: EU/1/10/643/001 20100906
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.