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Regadenoson - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for regadenoson?

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

Regadenoson has seventy-eight patent family members in twenty-five countries.

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

Summary for Generic Name: regadenoson

Tradenames:1
Patents:18
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packagers: see list1
Bulk Api Vendors: see list25
Clinical Trials: see list39
Patent Applications: see list74
Drug Prices:see low prices
DailyMed Link:regadenoson at DailyMed

Pharmacology for Ingredient: regadenoson

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYesYes8,106,029► Subscribe ► Subscribe
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYesYes7,683,037► Subscribe ► Subscribe
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYesYes6,642,210► SubscribeYY ► Subscribe
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYesYes8,106,183► SubscribeY ► Subscribe
Astellas
LEXISCAN
regadenoson
SOLUTION;INTRAVENOUS022161-001Apr 10, 2008RXYesYes9,289,446► SubscribeY ► Subscribe
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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► Subscribe
7,956,179Process for preparing an A2A-adenosine receptor agonist and its polymorphs► Subscribe
8,906,878Myocardial perfusion imaging methods and compositions► Subscribe
8,268,988Process for preparing an A2A-adenosine receptor agonist and its polymorphs► Subscribe
7,732,595Process for preparing an A.sub.2A-adenosine receptor agonist and its polymorphs► Subscribe
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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
World Intellectual Property Organization (WIPO)0162979► Subscribe
China101379073► Subscribe
South Korea20130130868► Subscribe
Luxembourg91785► Subscribe
European Patent Office1989214► Subscribe
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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
2011 00005Denmark► Subscribe
90003-2.LSweden► SubscribePRODUCT NAME: REGADENOSON OCH SALTER DAERAV; REG. NO/DATE: EU/1/10/643/001 20100906
C/GB11/005United Kingdom► SubscribePRODUCT NAME: REGADENOSON; REGISTERED: UK EU/1/10/643/001 20100906
00477Netherlands► SubscribePRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
2011Austria► SubscribePRODUCT NAME: REGADENOSON UND DESSEN SALZE; REGISTRATION NO/DATE: EU/1/10/643/001 20100906
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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 verifification 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.

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