NDAORALCAPSULE, EXTENDED RELEASE
Approved
May 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOCALIN XR is an extended-release capsule formulation of dexmethylphenidate hydrochloride, the active d-enantiomer of methylphenidate. It is indicated for attention-deficit/hyperactivity disorder (ADHD) in children and adults, providing sustained symptom control throughout the day via extended-release technology.
$0.002BPart D
LOE ApproachingProduct approaching loss of exclusivity signals potential team downsizing and shift from growth-focused commercial activities to defensive market share protection.
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 (3)
Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR
Started Jan 2006
77 enrolled
Attention Deficit Hyperactivity Disorder
Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions
Started Jun 2004
24 enrolled
Healthy
Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions
Started Jun 2004
24 enrolled
Healthy
Career Relevance
Zero linked job postings signal minimal hiring activity for FOCALIN XR; career opportunities are constrained by LOE proximity and mature lifecycle stage. Professionals assigned to this product should expect defensive commercial strategies and possible team restructuring.
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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.