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Ibrutinib - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ibrutinib?

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

This ingredient has one hundred and forty-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 list115
Patent Applications: see list162
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes8,735,403► SubscribeYY ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes8,754,091► SubscribeY ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes9,125,889► Subscribe ► Subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► 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
9,266,893Inhibitors of Bruton's tyrosine kinase► Subscribe
8,748,438Inhibitors of Bruton's tyrosine kinase► Subscribe
9,079,908Inhibitors of Bruton'S tyrosine kinase► Subscribe
9,556,182Inhibitors of Bruton's tyrosine kinase► Subscribe
9,133,198Inhibitors 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
European Patent Office2854859► Subscribe
Eurasian Patent Organization201300246► Subscribe
LithuaniaPA2016034► Subscribe
Canada2874756► Subscribe
Japan5347202► 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
2015 00021Denmark► SubscribePRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141023
00728Netherlands► SubscribePRODUCT NAME: IBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 20141021
0844Netherlands► SubscribePRODUCT NAME: IBRUTINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 - C(2016)3293 20160530
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
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