CONCERTA

LOE Approaching

methylphenidate hydrochloride

NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20

Mechanism of Action

(CNS) stimulant. The mode of therapeutic action of methylphenidate in the treatment of ADHD is not known. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space.

Clinical Trials (5)

NCT02730572N/ACompleted

Concerta (Methylphenidate) -To-Generic Switch Study

Started Sep 2015
1,464 enrolled
Attention Deficit Disorder With Hyperactivity
NCT01552915Phase 4Completed

Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

Started Apr 2012
464 enrolled
Attention-deficit/Hyperactivity Disorder
NCT01552902Phase 4Completed

Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder

Started Apr 2012
549 enrolled
Attention-deficit/Hyperactivity Disorder
NCT01338818Phase 3Completed

Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder

Started Apr 2011
299 enrolled
Attention Deficit/Hyperactivity Disorder
NCT01259492Phase 3Completed

Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

Started Nov 2010
725 enrolled
Attention Deficit/Hyperactivity Disorder