ARMODAFINIL

Post-LOE

armodafinil

Teva

ANDAORALTABLET

Approved

Mar 2019

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

ARMODAFINIL (armodafinil) by Teva is mechanism(s) through which armodafinil promotes wakefulness is unknown. Approved for excessive sleepiness, wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (osa), narcolepsy and 1 more indications. First approved in 2019.

Drug data last refreshed 19h ago

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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.

Clinical Trials (20)

NCT02552303N/ACompleted

The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia

Started Apr 2014

39 enrolled

Sleep ApneaInsomnia

NCT01781468Phase 3Completed

Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma

Started Jun 2013

328 enrolled

Fatigue

NCT01624480Phase 1Completed

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

Started Jul 2012

40 enrolled

Narcolepsy

NCT01305408Phase 3Completed

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Started Mar 2011

399 enrolled

Depression

NCT01121536Phase 3Terminated

Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Started Apr 2010

867 enrolled

Depression

ARMODAFINIL

Mechanism of Action

Indications (4)

Clinical Trials (20)