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Last Updated: May 19, 2022

Details for New Drug Application (NDA): 210563


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NDA 210563 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 210563
Tradename:IMBRUVICA
Applicant:Pharmacyclics Inc
Ingredient:ibrutinib
Patents:36
Formulation / Manufacturing:see details
Pharmacology for NDA: 210563
Mechanism of Action Protein 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: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
Patent:See Plans and PricingPatent Expiration:Jun 3, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
Patent:See Plans and PricingPatent Expiration:Jun 3, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

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