NDAORALCAPSULE, EXTENDED RELEASE
Approved
Apr 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
6/8 — Strong
APTENSIO XR (methylphenidate hydrochloride) by Teva is (cns) stimulant. Approved for attention deficit hyperactivity disorder. First approved in 2015.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APTENSIO XR is an extended-release oral capsule formulation of methylphenidate hydrochloride, a CNS stimulant approved in 2015 for ADHD and investigated for off-label use in cancer-related fatigue, anxiety disorders, and other conditions. The mechanism of action in ADHD remains incompletely understood, though the drug acts as a CNS stimulant to improve attention and reduce hyperactivity symptoms.
$0.044BPart D
PeakProduct is at peak lifecycle with modest Part D spending ($44K), indicating a mature market position with moderate team size supporting brand maintenance.
Mechanism of Action
(CNS) stimulant. The mode of therapeutic action in ADHD is not known.
Indications (1)
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.