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Ibrutinib - Generic Drug Details

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

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

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

Summary for Generic Name: ibrutinib

Tradenames:1
Patents:14
Applicants:1
NDAs:1
Drug Master File Entries: see list3
Suppliers / Packaging: see list1
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ibrutinib

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, 2013RXYes8,008,309► subscribeYY ► subscribe
Pharmacyclics Inc
IMBRUVICA
ibrutinib
CAPSULE;ORAL205552-001Nov 13, 2013RXYes8,703,780► 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
9,127,012Inhibitors of bruton's tyrosine kinase► subscribe
7,825,118Inhibitors 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 Ingredient: ibrutinib

Country Document Number Estimated Expiration
Australia2013271918► subscribe
Philippines12014502681► subscribe
Israel235894► 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
692Luxembourg► subscribePRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023
2015 00021Denmark► subscribePRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141021
2015017Lithuania► subscribePRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021
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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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