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Serving 500+ biopharmaceutical companies globally:

Novartis
Federal Trade Commission
Cerilliant
Fish and Richardson
Covington
Farmers Insurance
Fuji
Medtronic
US Army
Express Scripts

Generated: September 21, 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 one hundred and sixty-one patent family members in thirty-seven countries.

The generic ingredient in IMBRUVICA is ibrutinib. There are eight 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:18
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list39
Clinical Trials: see list83
Patent Applications: see list170
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 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► 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
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► 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
8,563,563Inhibitors of bruton's tyrosine kinase► Subscribe
8,759,516Inhibitors of Bruton's tyrosine kinase► Subscribe
8,658,653Inhibitors of Bruton's tyrosine kinase► Subscribe
9,193,735Inhibitors of Bruton's tyrosine kinase► Subscribe
8,748,438Inhibitors of Bruton's tyrosine kinase► Subscribe
9,206,189Inhibitors of bruton's tyrosine kinase► Subscribe
7,732,454Inhibitors of Bruton's tyrosine kinase► Subscribe
8,158,786Inhibitors of Bruton's tyrosine kinase► Subscribe
9,079,908Inhibitors of Bruton'S tyrosine kinase► Subscribe
8,809,273Inhibitors 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
HungaryS1600049► Subscribe
South Korea20100051863► Subscribe
Hong Kong1178144► Subscribe
European Patent Office2529621► Subscribe
Canada2663116► Subscribe
Denmark2081435► Subscribe
South Korea101464424► Subscribe
Israel235894► Subscribe
Spain2376424► Subscribe
Eurasian Patent Organization200900351► 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
321Luxembourg► SubscribePRODUCT NAME: INHIBITEURS DE LA TYROSINE KINASE DE BRUTON
0150014 00145Estonia► SubscribePRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
2016034Lithuania► SubscribePRODUCT NAME: IBRUTINIBAS ARBA FARMACISKAI PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2016)3293 20160526
3 5006-2015Slovakia► SubscribePRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023
0728Netherlands► SubscribeDETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN
15/020Ireland► SubscribePRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021
2017009Lithuania► SubscribePRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
2017000015Germany► SubscribePRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945-C(2015)4704 20150703
2015 00021Denmark► SubscribePRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141021
2016000093Germany► SubscribePRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20160526
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Covington
Express Scripts
Baxter
Farmers Insurance
Federal Trade Commission
US Army
QuintilesIMS
UBS
Fuji

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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