NDAORALTABLET
Approved
Nov 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOCALIN is a prescription oral tablet containing dexmethylphenidate hydrochloride, the active d-isomer of methylphenidate used to treat attention deficit hyperactivity disorder (ADHD). It is a central nervous system stimulant that increases dopamine and norepinephrine activity in the brain. The drug is indicated for ADHD management in pediatric and adult populations.
$0.093BPart D
LOE ApproachingDeclining
Product is in late lifecycle phase with modest Part D spending and relatively low claim volume, suggesting a mature franchise with shrinking commercial team investment.
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
Working on FOCALIN offers exposure to lifecycle management of a mature neuropsychiatric brand in a highly competitive generic-saturated market. This role builds expertise in defensive commercial strategies, payer negotiations, and formulary positioning rather than growth-stage launch experience.
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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.