ABILIFY ASIMTUFII

GrowthSM

aripiprazole

Otsuka
NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASE
Approved
Apr 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

unknown. The efficacy of aripiprazole could be mediated through a combination of partial agonist activity at dopamine D 2 and serotonin 5-HT 1A receptors and antagonist activity at 5-HT 2A receptors.

Pharmacologic Class:

Atypical Antipsychotic

Indications (2)

schizophreniafor the treatment of schizophrenia

Clinical Trials (5)

NCT04907279N/AUnknown

Aripiprazole Once-Monthly in Hospitalized Patients (INITIATE)

Started Nov 2021
200 enrolled
SchizophreniaSchizo Affective DisorderBipolar I Disorder
NCT04203056Phase 4Terminated

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Started Dec 2019
NCT04030143Phase 1/2Completed

A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

Started Aug 2019
266 enrolled
SchizophreniaBipolar I Disorder
NCT03881449Phase 4Unknown

DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole

Started Apr 2019
46 enrolled
SchizophreniaMajor Depressive DisorderBi-Polar Disorder+1 more
NCT03854409Phase 1Completed

A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder

Started Jan 2019
72 enrolled
SchizophreniaBipolar I Disorder

Loss of Exclusivity

LOE Date
Apr 23, 2033
86 months away
Patent Expiry
Apr 23, 2033

Patent Records (4)

Patent #ExpiryTypeUse Code
10517951
Apr 23, 2033
Product
U-3245
11097007
Apr 23, 2033
Product
U-3245
11638757
Apr 23, 2033
Product
U-3245
12016927
Apr 23, 2033
Product
U-3245
Company
Otsuka
Otsuka
Japan - Tokushima
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers