NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jun 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
RITALIN LA (methylphenidate) by Novartis is stimulant. First approved in 2002.
Drug data last refreshed 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RITALIN LA is an extended-release oral capsule formulation of methylphenidate, a CNS stimulant indicated primarily for Attention Deficit Hyperactivity Disorder, though the exact mechanism of therapeutic action in ADHD remains unknown. The drug is also used off-label for depression, autism spectrum disorder, methamphetamine dependence, fatigue, and other conditions.
$0.001BPart D
LOE ApproachingDeclining
With LOE approaching and modest Part D spending of $1M from only 1,958 claims in 2023, the RITALIN LA brand team is likely consolidating and preparing for generic erosion, signaling reduced headcount and budget allocation.
Mechanism of Action
stimulant. The mode of therapeutic action in ADHD is not known.
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.