NDAORALFOR SUSPENSION, EXTENDED RELEASE
Approved
Sep 2012
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
13
Data completeness
5/8 — Partial
QUILLIVANT XR (methylphenidate hydrochloride) by Teva is (cns) stimulant. First approved in 2012.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
QUILLIVANT XR is an extended-release oral suspension formulation of methylphenidate hydrochloride, a CNS stimulant approved in 2012 for ADHD treatment. It works by blocking the reuptake of norepinephrine and dopamine into presynaptic neurons, increasing their availability in the extraneuronal space. The suspension formulation enables flexible dosing, particularly for pediatric patients who may have difficulty swallowing tablets.
$0.196BPart D
Peak4.7 years to LOEProduct is at peak lifecycle stage with modest Part D utilization; commercial teams should anticipate competitive pressure and prepare for LOE defensibility strategies by 2031.
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 (13)
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
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
Started Sep 2014
36 enrolled
ADHDAutism
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.