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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 217003


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NDA 217003 describes IMBRUVICA, which is a drug marketed by Pharmacyclics Llc and is included in three NDAs. It is available from one supplier. There are forty-one 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 217003
Tradename:IMBRUVICA
Applicant:Pharmacyclics Llc
Ingredient:ibrutinib
Patents:15
Formulation / Manufacturing:see details
Pharmacology for NDA: 217003
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 217003
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMBRUVICA ibrutinib SUSPENSION;ORAL 217003 NDA Pharmacyclics LLC 57962-007 57962-007-12 1 BOTTLE, GLASS in 1 CARTON (57962-007-12) / 108 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength70MG/ML
Approval Date:Aug 24, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 24, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Feb 24, 2026
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Feb 24, 2030
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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