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 17h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROVIGIL (modafinil) is an oral small-molecule sympathomimetic-like agent approved in 1998 for promoting wakefulness in patients with narcolepsy, sleep apnea, and shift work sleep disorder. Its exact mechanism remains incompletely understood, but it acts primarily through dopamine transporter inhibition and selective brain region activation, distinguishing it from classical stimulants like amphetamine. The drug produces wake-promoting, psychoactive, and mood-altering effects typical of CNS stimulants.
$0.013BPart D
LOE ApproachingAs a maturing product approaching loss of exclusivity with modest Part D spending ($13M in 2023), PROVIGIL brand teams face stabilization focus rather than growth-driven expansion.
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…
Worked on PROVIGIL at Hikma? Share your interview experience or compensation data (+7 days Pro)
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.