NDAORALCAPSULE
Approved
Nov 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
3/8 — Basic
Drug data last refreshed 11h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STRATTERA (atomoxetine hydrochloride) is a selective norepinephrine reuptake inhibitor approved for attention-deficit/hyperactivity disorder (ADHD) in children and adults. It is the first non-stimulant ADHD medication, offering an alternative mechanism to traditional amphetamine-based treatments. Atomoxetine works by increasing norepinephrine levels in the prefrontal cortex, improving attention and impulse control.
$0.002BPart D
LOE ApproachingDeclining
Product is entering loss-of-exclusivity phase with modest Part D presence, signaling reduced commercial team investment and transition focus toward market defense and generic transition planning.
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 (14)
Impact of Strattera and Behavior Therapy on the Home and School Functioning of Children With ADHD
Started Jan 2007
56 enrolled
Attention Deficit Hyperactivity Disorder
Efficacy and Tolerability of Atomoxetine (Strattera) in Adult Patients With Generalized Social Anxiety Disorder
Started Nov 2005
27 enrolled
Generalized Social Phobia
Placebo-Controlled Study of Atomoxetine Hydrochloride in the Treatment of Adults With ADHD and Comorbid Social Anxiety Disorder
Started Jun 2005
440 enrolled
Attention Deficit Hyperactivity DisorderComorbid Social Anxiety Disorder
A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Started Sep 2004
502 enrolled
Attention Deficit Hyperactivity Disorder
Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months)
Started Sep 2004
440 enrolled
ADHD
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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.