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Last Updated: May 25, 2022

Details for New Drug Application (NDA): 205552


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NDA 205552 describes IMBRUVICA, which is a drug marketed by Pharmacyclics Inc and is included in two NDAs. It is available from one supplier. There are forty 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 205552
Tradename:IMBRUVICA
Applicant:Pharmacyclics Inc
Ingredient:ibrutinib
Patents:36
Formulation / Manufacturing:see details
Pharmacology for NDA: 205552
Mechanism of Action Protein Kinase Inhibitors
Suppliers and Packaging for NDA: 205552
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMBRUVICA ibrutinib CAPSULE;ORAL 205552 NDA Pharmacyclics LLC 57962-007 57962-007-12 150 mL in 1 BOTTLE, GLASS (57962-007-12)
IMBRUVICA ibrutinib CAPSULE;ORAL 205552 NDA Pharmacyclics LLC 57962-070 57962-070-28 28 CAPSULE in 1 BOTTLE, PLASTIC (57962-070-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength140MG
Approval Date:Nov 13, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:May 6, 2023
Regulatory Exclusivity Use:FOR TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Regulatory Exclusivity Expiration:Mar 4, 2023
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WITHOUT 17P DELETION WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE THERAPY)
Regulatory Exclusivity Expiration:Jan 25, 2022
Regulatory Exclusivity Use:INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB

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