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IMBRUVICA Drug Profile

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Imbruvica is a drug marketed by Pharmacyclics Inc and is included in one NDA. It is available from one supplier. There are fifteen patents protecting this drug.

This drug has one hundred and forty-one patent family members in thirty-six countries.

The generic ingredient in IMBRUVICA is ibrutinib. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.

Summary for Tradename: IMBRUVICA

Patents:15
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list39
Clinical Trials: see list66
Patent Applications: see list162
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:IMBRUVICA at DailyMed

Pharmacology for Tradename: IMBRUVICA

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► subscribe► subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► subscribe► subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► subscribe► subscribe
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Non-Orange Book Patents for Tradename: IMBRUVICA

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
9,133,198Inhibitors of bruton'S tyrosine kinase► subscribe
8,735,404Inhibitors of Bruton's tyrosine kinase► subscribe
8,759,516Inhibitors of Bruton's tyrosine kinase► 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 Tradename: IMBRUVICA

Country Document Number Estimated Expiration
South Korea20130086957► subscribe
BrazilPI0810086► subscribe
South Korea101464424► 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: IMBRUVICA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00056Denmark► subscribePRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530
15/020Ireland► subscribe
692Luxembourg► subscribePRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023
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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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