NDAORALTABLET, EXTENDED RELEASE, CHEWABLE
Approved
Dec 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
6/8 — Strong
QUILLICHEW ER (methylphenidate hydrochloride) by Teva is (cns) stimulant. Approved for attention deficit hyperactivity disorder. First approved in 2015.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QUILLICHEW ER is an extended-release chewable tablet formulation of methylphenidate hydrochloride, a CNS stimulant approved in 2015 for ADHD and other neuropsychiatric indications. It works by blocking reuptake of norepinephrine and dopamine into presynaptic neurons, increasing their availability in the extraneuronal space. The chewable formulation addresses administration barriers for pediatric and patients with swallowing difficulties.
$0.26MPart D
Peak7.3 years to LOEProduct is in peak commercial phase with stable but modest Part D utilization; relatively small brand team given low claim volume.
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 (1)
Clinical Trials (12)
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
A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.
Started Oct 2018
0Attention Deficit Hyperactivity Disorder (ADHD)Attention Deficit Hyperactivity Disorder
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
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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.