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Last Updated: February 22, 2024

Regadenoson - Generic Drug Details


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What are the generic drug sources for regadenoson and what is the scope of patent protection?

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
Emory UniversityN/A
Siemens Medical SolutionsN/A

See all regadenoson clinical trials

Pharmacology 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
Apotex REGADENOSON regadenoson SOLUTION;INTRAVENOUS 207604-001 Apr 11, 2022 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
Mylan REGADENOSON regadenoson SOLUTION;INTRAVENOUS 213856-001 Apr 4, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma REGADENOSON regadenoson SOLUTION;INTRAVENOUS 216437-001 Oct 26, 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
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
Slovenia 1989214 ⤷  Try a Trial
Norway 341322 ⤷  Try a Trial
Australia 2007212542 Process for preparing an A2A-Adenosine receptor agonist and its polymorphs ⤷  Try a Trial
Portugal 1989214 ⤷  Try a Trial
Hong Kong 1127358 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) ⤷  Try a Trial
South Korea 20080090491 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 11C0004 France ⤷  Try a Trial PRODUCT NAME: REGADENOSON ET SES SELS; REGISTRATION NO/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 SZ 2/2011 Austria ⤷  Try a Trial PRODUCT NAME: REGADENOSON UND DESSEN SALZE
1189916 CA 2011 00005 Denmark ⤷  Try a Trial PRODUCT NAME: REGADENOSON OG SALTE DERAF
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Johnson and Johnson
Merck
Express Scripts
AstraZeneca

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