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Serving 500+ biopharmaceutical companies globally:

Covington
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Generated: June 22, 2017

DrugPatentWatch Database Preview

Ibrutinib - Generic Drug Details

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What are the generic drug sources for ibrutinib and what is the scope of ibrutinib freedom to operate?

Ibrutinib
is the generic ingredient in one branded drug marketed by Pharmacyclics Inc and is included in one NDA. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ibrutinib has one hundred and fifty-three patent family members in thirty-seven countries.

There are four drug master file entries for ibrutinib. One supplier is listed for this compound.

Summary for Generic Name: ibrutinib

Tradenames:1
Patents:16
Applicants:1
NDAs:1
Drug Master File Entries: see list4
Suppliers / Packagers: see list1
Bulk Api Vendors: see list39
Clinical Trials: see list185
Patent Applications: see list244
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ibrutinib at DailyMed

Pharmacology for Ingredient: ibrutinib

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, 2013RXYesYes9,540,382► Subscribe ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes8,697,711► SubscribeYY ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes8,735,403► SubscribeYY ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes7,514,444► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ibrutinib

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
8,088,781Inhibitors of brutons tyrosine kinase► Subscribe
8,952,015Inhibitors of Bruton's tyrosine kinase► Subscribe
8,940,750Inhibitors of bruton's tyrosine kinase► Subscribe
8,975,266Inhibitors of Bruton's tyrosine kinase► Subscribe
8,741,908Inhibitors 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 Ingredient: ibrutinib

Country Document Number Estimated Expiration
Australia2016250445► Subscribe
South Korea20130086957► Subscribe
China101610676► Subscribe
South Korea101425248► Subscribe
Portugal2529621► 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: IBRUTINIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
15/020Ireland► SubscribePRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021
321Luxembourg► SubscribePRODUCT NAME: INHIBITEURS DE LA TYROSINE KINASE DE BRUTON
2015 00021Denmark► SubscribePRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141023
2015017Lithuania► SubscribePRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021
00728Netherlands► SubscribePRODUCT NAME: IBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; 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 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Cipla
Citi
Dow
McKinsey
QuintilesIMS
Cantor Fitzgerald
Mallinckrodt
Deloitte
Federal Trade Commission

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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