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 Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOCALIN XR is an extended-release oral capsule formulation of dexmethylphenidate hydrochloride, a CNS stimulant approved for ADHD treatment. The drug's exact mechanism in ADHD remains unclear, though it is presumed to work by increasing dopamine and norepinephrine availability. It serves as a long-acting alternative to immediate-release stimulant formulations.
$0.002BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending indicates a niche franchise requiring defensive and transition planning by the commercial team.
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 XR currently shows zero linked job postings, reflecting its mature lifecycle status and low commercial priority at Novartis. Career opportunities on this product are limited and focused on defensive maintenance rather than growth initiatives.
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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.