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 36m ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOCALIN XR is an extended-release capsule formulation of dexmethylphenidate hydrochloride, the active d-isomer 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 ApproachingWith LOE approaching and modest Part D claims (~3,495 in 2023), the brand team is likely in defensive/optimization mode rather than growth-focused expansion.
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
FOCALIN XR is in a transition phase: limited near-term career growth opportunities given LOE trajectory, but roles focused on managed decline, generic defense, and patient retention remain critical. Most suitable for professionals comfortable with mature-product portfolio management and defensive market positioning.
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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.