NDAORALTABLET
Approved
Nov 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOCALIN is a prescription oral tablet containing dexmethylphenidate hydrochloride, the active d-isomer of methylphenidate. It is indicated for attention-deficit/hyperactivity disorder (ADHD) and works as a central nervous system stimulant by increasing dopamine and norepinephrine activity. The drug has been marketed since 2001 and represents a targeted formulation approach to ADHD management.
$0.093BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Medicare utilization; commercial teams likely focused on lifecycle management and defending market share against generic erosion.
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 Fasting Conditions
Started Jun 2004
24 enrolled
Healthy
Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions
Started Jun 2004
24 enrolled
Healthy
Career Relevance
FOCALIN offers limited new career opportunities given its LOE-approaching status and zero linked open positions; roles are primarily defensive and retention-focused rather than launch-oriented. Professionals joining this product would focus on competitive positioning, payer negotiations, and lifecycle extension rather than growth and market expansion.
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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.