NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jun 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Ritalin LA is an extended-release oral capsule formulation of methylphenidate, a central nervous system stimulant approved in 2002. It is indicated for attention-deficit/hyperactivity disorder (ADHD) in children and adults. Methylphenidate works by increasing dopamine and norepinephrine activity in the brain to improve focus and reduce impulsive behavior.
$0.001BPart D
LOE ApproachingMature product approaching loss of exclusivity with minimal Part D market presence; brand team likely focused on defending market share against generics.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Methylphenidate for Apathy in Veterans With Parkinson's Disease
Started Jan 2024
60 enrolled
Parkinson DiseaseApathy
A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine
Started Oct 2019
430,000 enrolled
Attention Deficit Disorder With Hyperactivity
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
Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
Started Sep 2018
0Attention Deficit Hyperactivity Disorder (ADHD)
A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
Started Sep 2018
0Attention Deficit Hyperactivity Disorder
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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.