NDAORALTABLET, CHEWABLE
Approved
Apr 2003
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 2003.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
METHYLIN is an oral chewable tablet formulation of methylphenidate hydrochloride, a CNS stimulant approved in 2003 for Attention Deficit Hyperactivity Disorder (ADHD). It works by blocking the reuptake of norepinephrine and dopamine into presynaptic neurons, increasing their availability in the extraneuronal space. The mechanism of therapeutic action in ADHD, while not fully understood, is thought to involve these monoamine pathways.
$0.004BPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Medicare spending; brand team likely focused on generic transition planning and specialty formulation retention strategies.
Mechanism of Action
(CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
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
Worked on METHYLIN at Teva? 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.