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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 210563


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NDA 210563 describes IMBRUVICA, which is a drug marketed by Pharmacyclics Llc and is included in three NDAs. It is available from one supplier. There are fifty-six patents protecting this drug and four Paragraph IV challenges. Additional details are available on the IMBRUVICA profile page.

The generic ingredient in IMBRUVICA is ibrutinib. There are sixteen 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 210563
Tradename:IMBRUVICA
Applicant:Pharmacyclics Llc
Ingredient:ibrutinib
Patents:37
Pharmacology for NDA: 210563
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 210563
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMBRUVICA ibrutinib TABLET;ORAL 210563 NDA Pharmacyclics LLC 57962-014 57962-014-28 1 BLISTER PACK in 1 CARTON (57962-014-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK
IMBRUVICA ibrutinib TABLET;ORAL 210563 NDA Pharmacyclics LLC 57962-280 57962-280-28 1 BLISTER PACK in 1 CARTON (57962-280-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength140MG
Approval Date:Feb 16, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 24, 2025
Regulatory Exclusivity Use:ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Regulatory Exclusivity Expiration:Aug 24, 2025
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Feb 24, 2026
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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