ARISTADA INITIO KIT

Peak

aripiprazole lauroxil

NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASE
Approved
Jun 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
6

Mechanism of Action

aripiprazole. Following intramuscular injection, aripiprazole lauroxil is likely converted by enzyme-mediated hydrolysis to N -hydroxymethyl aripiprazole, which is then hydrolyzed to aripiprazole. The mechanism of action of aripiprazole in schizophrenia is unclear. However, efficacy could be…

Indications (1)

Clinical Trials (5)

NCT04203056Phase 4Terminated

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

Started Dec 2019
NCT03345979Phase 3Completed

A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia

Started Nov 2017
NCT02634320Phase 4Completed

A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia

Started Dec 2015
NCT02636842Phase 1Completed

A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder

Started Dec 2015
NCT02320032Phase 1Completed

An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

Started Dec 2014

Loss of Exclusivity

LOE Date
Apr 6, 2039
159 months away
Patent Expiry
Apr 6, 2039

Patent Records (5)

Patent #ExpiryTypeUse Code
10112903
Jun 24, 2030
Substance
U-543
8796276
Jun 24, 2030
U-543
8431576
Oct 26, 2030
Substance
11154552
Aug 17, 2035
Product
10688091
Aug 17, 2035
Product