IMBRUVICA

PeakSM

ibrutinib

NDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Protein Kinase Inhibitors

Pharmacologic Class:

Kinase Inhibitor

Clinical Trials (5)

NCT07456891Phase 3Not Yet Recruiting

Remibrutinib Open Label Roll-over Post-trial Access Protocol

Started Apr 2026
212 enrolled
Indication of the Parent Protocol
NCT07222956Phase 2Not Yet Recruiting

A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS

Started Apr 2026
20 enrolled
Multiple Sclerosis (MS) - Relapsing-remittingMultiple Sclerosis (MS) Secondary ProgressiveMultiple Sclerosis (MS) Primary Progressive
NCT07358780N/ARecruiting

Remibrutinib in Real-world Clinical Practice - a US Sub-study

Started Feb 2026
505 enrolled
Chronic Spontaneous Urticaria
NCT07358364N/ARecruiting

Remibrutinib in Real-world Clinical Practice

Started Feb 2026
3,280 enrolled
Chronic Spontaneous Urticaria
NCT07408219N/ARecruiting

A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria Patients

Started Jan 2026
350 enrolled
Chronic Spontaneous Urticaria

Loss of Exclusivity

LOE Date
Sep 3, 2036
127 months away
Patent Expiry
Sep 3, 2036
Exclusivity Expiry
Feb 24, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
8735403
Dec 28, 2026
SubstanceProduct
8476284
Dec 28, 2026
U-1650
8497277
Dec 28, 2026
U-2242
8703780
Dec 28, 2026
U-2242
8952015
Dec 28, 2026
U-2241