METHYLPHENIDATE

Post-LOE

methylphenidate

Viatris (2)

ANDATRANSDERMALFILM, EXTENDED RELEASE

Approved

Mar 2022

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

Drug Shortage Active

METHYLPHENIDATE is currently in shortage. Reason: Available. This may impact manufacturing, supply chain, and quality hiring at the manufacturer.

METHYLPHENIDATE (methylphenidate) by Viatris (2) is stimulant. Approved for attention deficit hyperactivity disorder (adhd) in pediatric patients 6 to 17 years of age. First approved in 2022.

Drug data last refreshed 19h ago

$0.0BPart D

Mechanism of Action

stimulant. Its mode of therapeutic action in ADHD is not known.

Pharmacologic Class:

Central Nervous System Stimulant

Indications (1)

Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age

Clinical Trials (20)

NCT05669170Phase 2Not Yet Recruiting

Methylphenidate for Apathy in Veterans With Parkinson's Disease

Started Jan 2024

60 enrolled

Parkinson DiseaseApathy

NCT04132557N/ACompleted

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

NCT03785223Phase 4Completed

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

NCT03546400Phase 4Withdrawn

Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.

Started Sep 2018

Attention Deficit Hyperactivity Disorder (ADHD)

NCT03536390Phase 4Withdrawn

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

Attention 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.