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Last Updated: March 19, 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

See drug prices for LEXISCAN

Recent Clinical Trials for LEXISCAN

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

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

See all LEXISCAN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LEXISCAN
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Try a Trial ⤷  Try a Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 40089
Estimated Expiration: ⤷  Try a Trial

Patent: 87759
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1379073
Estimated Expiration: ⤷  Try a Trial

Patent: 2260311
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 89214
Estimated Expiration: ⤷  Try a Trial

Patent: 81381
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 27358
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3153
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 26156
Estimated Expiration: ⤷  Try a Trial

Patent: 09525347
Estimated Expiration: ⤷  Try a Trial

Patent: 13010791
Estimated Expiration: ⤷  Try a Trial

Patent: 13014620
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10014060
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0239
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 1322
Estimated Expiration: ⤷  Try a Trial

Patent: 083395
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 89214
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 89214
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 47081
Estimated Expiration: ⤷  Try a Trial

Patent: 08131956
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 89214
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0806666
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1494125
Estimated Expiration: ⤷  Try a Trial

Patent: 080090491
Estimated Expiration: ⤷  Try a Trial

Patent: 130130868
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 93028
Estimated Expiration: ⤷  Try a Trial

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
Mexico PA05001123 FORMACION DE IMAGENES POR PERFUSION DE MIOCARDIO MEDIANTE EL USO DE AGONISTAS RECEPTORES DE A2A. (MYOCARDIAL PERFUSION IMAGING USING A2A RECEPTOR AGONISTS.) ⤷  Try a Trial
Japan 2009525347 ⤷  Try a Trial
Poland 1989214 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LEXISCAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1189916 SZ 2/2011 Austria ⤷  Try a Trial PRODUCT NAME: REGADENOSON UND DESSEN SALZE
1189916 2/2011 Austria ⤷  Try a Trial PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 392 Finland ⤷  Try a Trial
>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.