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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, 2008RXYes7,655,637<disabled>YY <disabled>
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYes9,289,446<disabled>Y <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
8,071,566Methods of coronary imaging<disabled in preview>
8,906,878Myocardial perfusion imaging methods and compositions<disabled in preview>
8,524,883Monohydrate of (1-{9-[4S,2R,3R,5R)-3,4-dihydroxy-5-(hydroxymethyl)oxolan-2-yl]-6-aminopu- rin-2-yl}pyrazol-4-yl)-N-methylcarboxamide<disabled in preview>
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International Patent Family for Ingredient: regadenoson

Country Document Number Estimated Expiration
South Korea101494125<disabled in preview>
European Patent Office1989214<disabled in preview>
China1358191<disabled in preview>
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Supplementary Protection Certificates for Tradename: REGADENOSON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2Finland<disabled>
C004/2011Ireland<disabled>SPC004/2011: 20110719, EXPIRES: 20250620
C/GB11/005United Kingdom<disabled>PRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906
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