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Last Updated: May 24, 2024

Details for New Drug Application (NDA): 205552

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NDA 205552 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-four 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
Applicant:Pharmacyclics Llc
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 57962-070-28 28 CAPSULE in 1 BOTTLE, PLASTIC (57962-070-28)
IMBRUVICA ibrutinib CAPSULE;ORAL 205552 NDA Pharmacyclics LLC 57962-140 57962-140-09 90 CAPSULE in 1 BOTTLE, PLASTIC (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:Aug 24, 2025
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Feb 2, 2025
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Feb 24, 2026
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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