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Serving leading biopharmaceutical companies globally:

Cerilliant
Covington
McKinsey
Deloitte
Fish and Richardson
US Department of Justice
Farmers Insurance
McKesson
QuintilesIMS
Baxter

Generated: November 18, 2017

DrugPatentWatch Database Preview

IMBRUVICA Drug Profile

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What is the patent landscape for Imbruvica, and when can generic versions of Imbruvica launch?

Imbruvica is a drug marketed by Pharmacyclics Inc and is included in one NDA. There are eighteen patents protecting this drug.

This drug has two hundred patent family members in thirty-eight countries and twenty-two supplementary protection certificates in ten countries.

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

Pharmacology for IMBRUVICA

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► 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
8,236,812Inhibitors of bruton's tyrosine kinase► Subscribe
9,801,883Use of inhibitors of bruton's tyrosine kinase (Btk)► Subscribe
9,206,189Inhibitors of bruton's tyrosine kinase► Subscribe
9,127,012Inhibitors of bruton's tyrosine kinase► Subscribe
9,133,201Inhibitors of Bruton's tyrosine kinase► Subscribe
8,809,273Inhibitors of Bruton's tyrosine kinase► Subscribe
9,212,185Inhibitors of Bruton's tyrosine kinase► Subscribe
7,732,454Inhibitors of Bruton's tyrosine kinase► Subscribe
9,079,908Inhibitors of Bruton'S tyrosine kinase► Subscribe
8,088,781Inhibitors of brutons 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
Eurasian Patent Organization201270793► Subscribe
HungaryS1500018► Subscribe
South Korea101464424► Subscribe
Canada2681756► Subscribe
China101610676► Subscribe
New Zealand702548► Subscribe
Japan2013060466► Subscribe
Japan2013527249► Subscribe
Portugal2526771► Subscribe
SloveniaEP2529621► 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
2017009Lithuania► SubscribePRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
2017 00012Denmark► SubscribePRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2015)4704 20150707
0868Netherlands► SubscribePRODUCT NAME: IBRUTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/14/945 - C(2015)4704 20150707
2015 00021Denmark► SubscribePRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141021
692Luxembourg► SubscribePRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023
2015017Lithuania► SubscribePRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021
90021-0Sweden► SubscribePRODUCT NAME: IBRUTINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/14/945 20141023
0728Netherlands► SubscribeDETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN
2016 00056Denmark► SubscribePRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530
2015017,C2201840Lithuania► SubscribePRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 20141021
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Cerilliant
US Department of Justice
Harvard Business School
Medtronic
Daiichi Sankyo
Covington
Deloitte
US Army
Baxter

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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