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Last Updated: October 26, 2020

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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 one branded drug marketed by Astellas and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Regadenoson has fifty-eight patent family members in twenty-six countries.

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

Recent Clinical Trials for regadenoson

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

SponsorPhase
University of Maryland, BaltimoreEarly Phase 1
National Heart, Lung, and Blood Institute (NHLBI)Early Phase 1
Emory UniversityN/A

See all regadenoson clinical trials

Pharmacology for regadenoson
Paragraph IV (Patent) Challenges for REGADENOSON
Tradename Dosage Ingredient NDA Submissiondate
LEXISCAN SOLUTION;INTRAVENOUS regadenoson 022161 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
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 RX Yes Yes   Start Trial   Start Trial Y Y   Start 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   Start Trial   Start Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008   Start Trial   Start Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008   Start Trial   Start Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008   Start Trial   Start Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for regadenoson

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1189916 91785 Luxembourg   Start Trial 91785, EXPIRES: 20250621
1189916 C01189916/01 Switzerland   Start Trial PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
1189916 SPC/GB11/005 United Kingdom   Start Trial PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906
1189916 392 Finland   Start Trial
1189916 122011000010 Germany   Start Trial PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/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:

Baxter
Medtronic
Johnson and Johnson
Merck
Express Scripts
AstraZeneca

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.