NDAORALTABLET
Approved
Nov 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
FOCALIN (dexmethylphenidate hydrochloride) by Novartis is stimulant. First approved in 2001.
Drug data last refreshed 20h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOCALIN is a central nervous system stimulant containing dexmethylphenidate hydrochloride, the active d-isomer of methylphenidate, approved for ADHD treatment. It is delivered as an oral tablet and works through sympathomimetic mechanisms, though the exact therapeutic action in ADHD remains not fully elucidated. FOCALIN is a small-molecule NDA product sponsored by Novartis since its 2001 approval.
$0.093MPart D
LOE ApproachingDeclining
Product is in LOE-approaching phase with modest Part D utilization (829 claims in 2023), signaling preparation for generic competition and potential rightsizing of commercial teams.
Mechanism of Action
stimulant. The mode of therapeutic action in ADHD is not known.
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
FOCALIN offers limited career growth potential due to its LOE-approaching status and minimal current job openings (0 linked positions). Roles on this product are primarily defensive in nature—focused on managing decline, maintaining market share against generics, and optimizing the exit strategy rather than building market presence or innovation.
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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.