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Cantor Fitzgerald
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Chinese Patent Office
Covington
AstraZeneca
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Generated: June 18, 2018

DrugPatentWatch Database Preview

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 twenty-four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the IMBRUVICA profile page.

The generic ingredient in IMBRUVICA is ibrutinib. There are thirteen 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:23
Formulation / Manufacturing:see details
Pharmacology for NDA: 205552
Mechanism of ActionProtein 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 57962-070 N 57962-070-28
IMBRUVICA ibrutinib CAPSULE;ORAL 205552 NDA Pharmacyclics LLC 57962-140 N 57962-140-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength140MG
Approval Date:Nov 13, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:May 6, 2019
Regulatory Exclusivity Use:DOSING RECOMMENDATION ADDED TO THE LABELING FOR IMBRUVICA USE IN COMBINATION WITH BENDAMUSTINE AND RITUXIMAB FOR THE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)/SMALL LYMPHOCYTIC LEUKEMIA (SLL)
Regulatory Exclusivity Expiration:Jan 29, 2018
Regulatory Exclusivity Use:FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM MACROGLOBULINEMIA
Regulatory Exclusivity Expiration:May 6, 2023
Regulatory Exclusivity Use:FOR TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)

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