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 15h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUVIGIL (armodafinil) is the R-enantiomer of modafinil, an oral wakefulness-promoting agent approved for excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder. Its mechanism is incompletely understood but involves indirect dopamine receptor agonism and dopamine transporter inhibition, producing wake-promoting effects distinct from traditional sympathomimetic amines. The drug crosses the blood-brain barrier and increases extracellular dopamine in key brain regions.
$0.004BPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Medicare spending ($4M, 2690 claims in 2023); expect commercial team contraction as generic competition intensifies.
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.