NDAORALTABLET
Approved
Dec 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
PROVIGIL (modafinil) by Hikma is mechanism(s) through which modafinil promotes wakefulness is unknown. First approved in 1998.
Drug data last refreshed 16h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROVIGIL (modafinil) is an oral small-molecule sympathomimetic-like CNS stimulant approved in 1998 for promoting wakefulness. The exact mechanism is not fully understood, but it appears to work primarily through dopamine transporter inhibition and selective neuronal activation in discrete brain regions, distinguishing it from traditional amphetamines. Patients with narcolepsy, obstructive sleep apnea, and shift-work sleep disorder are the primary users.
$0.013BPart D
LOE ApproachingProduct is approaching loss of exclusivity with moderate Part D engagement; brand team size likely contracting or consolidating.
Mechanism of Action
mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although the pharmacologic profile is not identical to that of the sympathomimetic amines. Modafinil-induced…
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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.