NDAORALCAPSULE, EXTENDED RELEASE
Approved
Apr 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
2/8 — Basic
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
METADATE CD is an extended-release oral capsule formulation of methylphenidate hydrochloride, a CNS stimulant approved in 2001 for treating Attention Deficit Hyperactivity Disorder (ADHD). The drug works by blocking the reuptake of norepinephrine and dopamine into presynaptic neurons, increasing monoamine availability in the extraneuronal space, though the exact mechanism in ADHD remains incompletely understood.
LOE Approaching
As an approaching LOE product under Aytu BioPharma ownership, the brand team is likely focused on defending market share against generic and branded competitors rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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.