NDAORALTABLET
Approved
Jun 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
NUVIGIL (armodafinil) by Teva is mechanism(s) through which armodafinil promotes wakefulness is unknown. First approved in 2007.
Drug data last refreshed 11h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUVIGIL (armodafinil) is an oral wakefulness-promoting agent approved in 2007 for narcolepsy, obstructive sleep apnea, and shift work sleep disorder. The R-enantiomer of modafinil, armodafinil works via dopamine transporter inhibition and indirect dopamine receptor agonism, though its precise mechanism of wakefulness promotion remains incompletely understood. It is structurally distinct from sympathomimetic amines despite similar wake-promoting effects.
$0.004BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending ($4M, 2,690 claims in 2023) signals a mature, niche indication with limited revenue expansion potential for brand teams.
Mechanism of Action
mechanism(s) through which armodafinil promotes wakefulness is unknown. Armodafinil (R-modafinil) has pharmacological properties similar to those of modafinil (a mixture of R- and S-modafinil), to the extent tested in animal and in vitro studies. The R- and S-enantiomers have similar…
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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.