NDAORALTABLET
Approved
Jul 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
Pharmacologic Class:
Atypical Antipsychotic
Clinical Trials (5)
REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)
Started Apr 2025
200 enrolled
Alzheimer Disease
Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia
Started Oct 2023
59 enrolled
Schizophrenia
Real-life Assessment of Brexpiprazole (Rexulti) in Schizophrenia and in Depressive Disorders
Started Jul 2023
40 enrolled
PsychosisDepression
A Trial to Assess the Effects of Prazosin or Propranolol on Blood Pressure in the Presence of Brexpiprazole/Sertraline
Started Sep 2022
34 enrolled
Post-traumatic Stress Disorder (PTSD)
Open-label Brexpiprazole fMRI Trial in Adults With Major Depressive Disorder and Anxiety
Started Aug 2022
0Major Depressive Disorder (MDD)
Loss of Exclusivity
LOE Date
Apr 12, 2033
86 months away
Patent Expiry
Apr 12, 2033
Exclusivity Expiry
May 9, 2028
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 9839637 | Apr 12, 2026 | Product | U-543 |
| 7888362 | Apr 12, 2026 | Substance | — |
| 8349840 | Apr 12, 2026 | Product | U-1529 |
| 8618109 | Apr 12, 2026 | U-3281 | |
| 8618109*PED | Oct 12, 2026 | — |
Company
Otsuka
Japan - Tokushima