NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
Schedule 2
CONCERTA (methylphenidate hydrochloride) by Johnson & Johnson is (cns) stimulant. Approved for attention deficit hyperactivity disorder (adhd) in patients aged 6 to 65 years old. First approved in 2000.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CONCERTA is an oral, extended-release tablet formulation of methylphenidate hydrochloride, a CNS stimulant approved by the FDA in August 2000. It is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older, as well as adolescents. The drug works by blocking the reuptake of norepinephrine and dopamine into presynaptic neurons, thereby increasing the release of these monoamines into the extraneuronal space. As a Schedule II controlled substance with a small-molecule, immediate-release competitor base, CONCERTA remains a foundational therapy in ADHD management despite approaching loss of exclusivity.
$0.0BPart D
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 (20)
A 14 Week, Randomized, Placebo-Controlled Cross-Over Study of Methylphenidate Hydrochloride Controlled Release Capsules in Adult ADHD With and Without Anxiety Disorder Comorbidity
Started Apr 2019
60 enrolled
Attention Deficit Hyperactivity DisorderGeneralized Anxiety DisorderSocial Anxiety Disorder+2 more
Concerta (Methylphenidate) -To-Generic Switch Study
Started Sep 2015
1,464 enrolled
Attention Deficit Disorder With Hyperactivity
A Study Comparing Long-acting Methylphenidate (ConcertaTM) vs. Placebo in the Treatment of Memory Loss Due to HIV
Started May 2012
40 enrolled
HIV Dementia
Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
Started Apr 2012
464 enrolled
Attention-deficit/Hyperactivity Disorder
Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
Started Apr 2012
549 enrolled
Attention-deficit/Hyperactivity Disorder
Worked on CONCERTA at Johnson & Johnson? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.