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Last Updated: May 21, 2022

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 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.

DrugPatentWatch® 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 six 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

DrugPatentWatch® Estimated 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
Siemens Medical SolutionsN/A
Emory UniversityN/A
University of Maryland, BaltimoreEarly Phase 1

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 three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LEXISCAN is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting LEXISCAN

N-pyrazole A2A adenosine receptor agonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR STIMULATING CORONARY VASODILATION FOR PURPOSES OF IMAGING THE HEART

Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process for preparing an A2A-adenosine receptor agonist and its polymorphs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 See Plans and Pricing See Plans and Pricing
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 See Plans and Pricing See Plans and Pricing
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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: See Plans and Pricing

Canada

Patent: 40089
Estimated Expiration: See Plans and Pricing

Patent: 87759
Estimated Expiration: See Plans and Pricing

China

Patent: 1379073
Estimated Expiration: See Plans and Pricing

Patent: 2260311
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 89214
Estimated Expiration: See Plans and Pricing

Patent: 81381
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 27358
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3153
Estimated Expiration: See Plans and Pricing

Patent: 2700
Estimated Expiration: See Plans and Pricing

Japan

Patent: 26156
Estimated Expiration: See Plans and Pricing

Patent: 09525347
Estimated Expiration: See Plans and Pricing

Patent: 13010791
Estimated Expiration: See Plans and Pricing

Patent: 13014620
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10014060
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0239
Estimated Expiration: See Plans and Pricing

Norway

Patent: 1322
Estimated Expiration: See Plans and Pricing

Patent: 083395
Estimated Expiration: See Plans and Pricing

Poland

Patent: 89214
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 89214
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 47081
Estimated Expiration: See Plans and Pricing

Patent: 08131956
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 89214
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0806666
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1494125
Estimated Expiration: See Plans and Pricing

Patent: 080090491
Estimated Expiration: See Plans and Pricing

Patent: 130130868
Estimated Expiration: See Plans and Pricing

Spain

Patent: 93028
Estimated Expiration: See Plans and Pricing

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
Norway 322457 See Plans and Pricing
Israel 252700 See Plans and Pricing
South Africa 200703229 Use of A2A adenosine receptor agonists See Plans and Pricing
Norway 20072540 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LEXISCAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1189916 91785 Luxembourg See Plans and Pricing 91785, EXPIRES: 20250621
1189916 C300477 Netherlands See Plans and Pricing PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 SPC004/2011 Ireland See Plans and Pricing SPC004/2011: 20110719, EXPIRES: 20250620
1189916 2011C/004 Belgium See Plans and Pricing 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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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.