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. Fifteen 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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Summary for LEXISCAN
| International Patents: | 28 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 69 |
| Clinical Trials: | 47 |
| Patent Applications: | 380 |
| Drug Prices: | Drug price information for LEXISCAN |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LEXISCAN |
| What excipients (inactive ingredients) are in LEXISCAN? | LEXISCAN excipients list |
| DailyMed Link: | LEXISCAN at DailyMed |
Recent Clinical Trials for LEXISCAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| St. Jude Children's Research Hospital | Phase 2 |
| Emory University | N/A |
| Siemens Medical Solutions | N/A |
Pharmacology for LEXISCAN
| Drug Class | Adenosine Receptor Agonist Pharmacologic Cardiac Stress Test Agent |
| Mechanism of Action | Adenosine Receptor Agonists |
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 |
| 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 |
|---|---|---|---|
| Mexico | 2010014060 | PROCESO PARA PREPARAR UN AGONISTA DE RECEPTOR DE ADENOSINA A2A Y SUS POLIMORFAS. (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS.) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 0162979 | ⤷ Sign Up | |
| Australia | 2003259264 | MYOCARDIAL PERFUSION IMAGING USING A2A RECEPTOR AGONISTS | ⤷ Sign Up |
| Germany | 122011000010 | ⤷ Sign Up | |
| South Africa | 200703229 | Use of A2A adenosine receptor agonists | ⤷ Sign Up |
| Poland | 1989214 | ⤷ Sign Up | |
| Norway | 2011002 | ⤷ 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 | 122011000010 | Germany | ⤷ Sign Up | PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 |
| 1189916 | SPC004/2011 | Ireland | ⤷ Sign Up | SPC004/2011: 20110719, EXPIRES: 20250620 |
| 1189916 | C01189916/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017 |
| 1189916 | 2/2011 | Austria | ⤷ Sign Up | PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 |
| 1189916 | 11C0004 | France | ⤷ Sign Up | PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 |
| 1189916 | CA 2011 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: REGADENOSON OG SALTE DERAF |
| 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.
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