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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 fourteen patents protecting this drug.

This drug has one hundred and thirty-two patent family members in thirty-three countries.

The generic ingredient in IMBRUVICA is ibrutinib. There are three 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:14
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: IMBRUVICA

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYes► subscribe► subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYes► subscribe► subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYes8,476,284► 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
9,139,591Inhibitors of bruton's tyrosine kinase► subscribe
8,952,015Inhibitors of Bruton's tyrosine kinase► subscribe
9,133,201Inhibitors 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
Canada2663116► subscribe
Argentina092844► subscribe
European Patent Office2526933► 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
2015 00021Denmark► subscribePRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141023
90021-0Sweden► subscribePRODUCT NAME: IBRUTINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/14/945 20141023
0150014 00145Estonia► subscribePRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
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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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