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Last Updated: October 24, 2021

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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. There are two tentative approvals for this compound.

Summary for regadenoson
Recent Clinical Trials for regadenoson

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

SponsorPhase
University of Maryland, BaltimorePhase 1/Phase 2
GE HealthcarePhase 1/Phase 2
CovancePhase 1/Phase 2

See all regadenoson clinical trials

Generic filers with tentative approvals for REGADENOSON
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial0.4MG/5ML (0.08MG/ML)SOLUTION;INTRAVENOUS
⤷  Free Forever Trial⤷  Free Forever Trial0.4MG/5ML (0.08MG/ML)SOLUTION;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astellas LEXISCAN regadenoson SOLUTION;INTRAVENOUS 022161-001 Apr 10, 2008 ⤷  Free Forever Trial ⤷  Free Forever 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 392 Finland ⤷  Free Forever Trial
1189916 2/2011 Austria ⤷  Free Forever Trial PRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 C300477 Netherlands ⤷  Free Forever Trial PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 122011000010 Germany ⤷  Free Forever Trial PRODUCT NAME: REGADENOSON UND DIE SALZE DAVON; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
1189916 SPC004/2011 Ireland ⤷  Free Forever Trial SPC004/2011: 20110719, EXPIRES: 20250620
1189916 SZ 2/2011 Austria ⤷  Free Forever Trial PRODUCT NAME: REGADENOSON UND DESSEN SALZE
>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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