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Regadenoson - Generic Drug Details

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

This ingredient has seventy-seven patent family members in twenty-four countries.

There are five drug master file entries for regadenoson. One supplier is listed for this compound.

Summary for Generic Name: regadenoson

Tradenames:1
Patents:17
Applicants:1
NDAs:1
Drug Master File Entries: see list5
Suppliers / Packaging: see list1

Pharmacology for Ingredient: regadenoson

Clinical Trials for: regadenoson

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes7,655,636<disabled> <disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes9,289,446<disabled>Y <disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes7,655,637<disabled>YY <disabled>
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Non-Orange Book Patents for Generic Ingredient: regadenoson

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,278,435N-pyrazole A2A receptor agonists<disabled in preview>
8,906,878Myocardial perfusion imaging methods and compositions<disabled in preview>
7,956,179Process for preparing an A2A-adenosine receptor agonist and its polymorphs<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: regadenoson

Country Document Number Estimated Expiration
China1358191<disabled in preview>
Portugal1189916<disabled in preview>
Spain2209974<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: REGADENOSON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C004/2011Ireland<disabled>SPC004/2011: 20110719, EXPIRES: 20250620
90003-2.LSweden<disabled>PRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
2Finland<disabled>
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