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Last Updated: March 29, 2024

Regadenoson - Generic Drug Details


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What are the generic sources for regadenoson and what is the scope of freedom to operate?

Regadenoson is the generic ingredient in two branded drugs marketed by Astellas, Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Ims Ltd, Meitheal, and Mylan, and is included in twelve NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Regadenoson has twenty-eight patent family members in eighteen countries.

There are nine drug master file entries for regadenoson. Fourteen suppliers are listed for this compound.

Drug Prices for regadenoson

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Recent Clinical Trials for regadenoson

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 regadenoson clinical trials

Pharmacology for regadenoson
Anatomical Therapeutic Chemical (ATC) Classes for regadenoson
Paragraph IV (Patent) Challenges for REGADENOSON
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 regadenoson

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ims Ltd REGADENOSON regadenoson SOLUTION;INTRAVENOUS 214252-001 May 23, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma REGADENOSON regadenoson SOLUTION;INTRAVENOUS 215827-001 Feb 2, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
Gland Pharma Ltd REGADENOSON regadenoson SOLUTION;INTRAVENOUS 207320-001 Jul 12, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys REGADENOSON regadenoson SOLUTION;INTRAVENOUS 213210-001 Apr 11, 2022 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 regadenoson

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
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 regadenoson

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 regadenoson

Country Patent Number Title Estimated Expiration
Spain 2593028 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2007092372 ⤷  Try a Trial
Japan 2013014620 PROCESS FOR PREPARING A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS ⤷  Try a Trial
New Zealand 570239 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 ⤷  Try a Trial
European Patent Office 1989214 PROCEDE DE PREPARATION D'UN AGONISTE DE RECEPTEUR A2A-ADENOSINE ET SES POLYMORPHES (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for regadenoson

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1189916 2011C/004 Belgium ⤷  Try a Trial PRODUCT NAME: REGADENOSON; AUTHORISATION NUMBER AND DATE: EU/1/10/643/001 20100906
1189916 C300477 Netherlands ⤷  Try a Trial PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 122011000010 Germany ⤷  Try a Trial PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 2/2011 Austria ⤷  Try a Trial PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 C01189916/01 Switzerland ⤷  Try a Trial PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
>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.