NDAORALSOLUTION
Approved
Dec 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
4/8 — Partial
METHYLIN (methylphenidate hydrochloride) by Teva is (cns) stimulant. First approved in 2002.
Drug data last refreshed 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
METHYLIN is an oral solution formulation of methylphenidate hydrochloride, a CNS stimulant approved in 2002 for ADHD and off-label use in fatigue and anxiety disorders. The exact mechanism of therapeutic action in ADHD remains unknown, though it functions as a central nervous system stimulant. Primary patient population includes children and adults with attention deficit hyperactivity disorder seeking an alternative to tablet formulations.
$0.004BPart D
LOE ApproachingDeclining
Product approaching LOE with minimal Part D spending ($4K in 2023) and only 44 claims suggests a niche formulation with a small, specialized team focused on brand defense rather than growth.
Mechanism of Action
(CNS) 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 (11)
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
Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder
Started Apr 2011
299 enrolled
Attention Deficit/Hyperactivity Disorder
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
Adult Study / OROS Methylphenidate Hydrochloride (HCL) (OROS MPH) in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Started Jul 2009
357 enrolled
Attention Deficit Disorder With Hyperactivity
Efficacy Study of Methylphenidate Hydrochloride to Reduce Fatigue in Prostate Cancer Patients Receiving Hormone Therapy
Started Jan 2008
33 enrolled
Prostatic NeoplasmsFatigue
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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.