NDATRANSDERMALFILM, EXTENDED RELEASE
Approved
Apr 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
DAYTRANA (methylphenidate) by Noven Pharmaceuticals is stimulant. Approved for attention deficit hyperactivity disorder. First approved in 2006.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DAYTRANA is a transdermal extended-release film formulation of methylphenidate, a CNS stimulant approved in 2006 for ADHD and used off-label across multiple indications including depression, fatigue, and neurological disorders. Its exact mechanism of action in ADHD remains unknown, though it is presumed to work via dopamine and norepinephrine reuptake inhibition. The transdermal delivery system provides sustained therapeutic levels and improved tolerability compared to oral formulations.
$0.429MPart D
LOE ApproachingStable
Limited commercial opportunity with approaching loss of exclusivity and modest Part D spending signals a mature product nearing generic transition.
Mechanism of Action
stimulant. Its mode of therapeutic action in ADHD is not known.
Pharmacologic Class:
Central Nervous System Stimulant
Indications (1)
Clinical Trials (20)
Methylphenidate for Apathy in Veterans With Parkinson's Disease
Started Jan 2024
60 enrolled
Parkinson DiseaseApathy
A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine
Started Oct 2019
430,000 enrolled
Attention Deficit Disorder With Hyperactivity
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
Safety, Tolerability and PK Study of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD.
Started Sep 2018
0Attention Deficit Hyperactivity Disorder (ADHD)
A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD
Started Sep 2018
0Attention Deficit Hyperactivity Disorder
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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.