Modafinil

For excessive sleepiness associated with narcolepsy. Sold as Provigil. Every FDA application for this active ingredient: 1 branded and 14 generic.

As of Nov 14, 2026, FDA lists 15 applications for Modafinil (sold as Provigil), first approved Dec 24, 1998, with 1 new use approved and 0 published complete response letters.

First approved: Dec 24, 1998
Applications: 15
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $37.6M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Modafinil	Part D	$24.2M	-10%	85,029
Provigil	Part D	$13.5M	+2%	454

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

MODAFINIL 100 MG TABLET: $0.254 per unitGeneric · -15% in a year
MODAFINIL 200 MG TABLET: $0.353 per unitGeneric · -9% in a year
PROVIGIL 100 MG TABLET: $53.18 per unitBrand · +0% in a year
PROVIGIL 200 MG TABLET: $80.25 per unitBrand · 0% in a year

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of excessive daytime sleepiness in narcolepsy.Cephalon, Inc. · designated Mar 15, 1993 · approved Dec 24, 1998

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

ModiodalA drug with a new indication for the treatment of excessive daytime sleepiness associated with idiopathic hypersomnia. · Alfresa Pharma Corporation · Feb 21, 2020
ModiodalA drug with a new additional indication for the treatment of excessive daytime sleepiness in patients with obstructive sleep apnea syndrome who receive… · Alfresa Pharma Corporation · Nov 25, 2011

Clinical Trials

15 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Psilocybin for Depression in VeteransMajor Depression · VA Office of Research and Development	Phase 2	Not yet recruiting	Oct 26, 2026
Efficacy and Safety of Modafinil to Treat Fatigue in People With Mitochondrial Disease.Mitochondrial Disease · Kenneth Myers, MD	Phase 3	Not yet recruiting	Oct 21, 2026
Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial)Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Chronic Fatigue · Radboud University Medical Center	Phase 2 / Phase 3	Recruiting	May 12, 2026
Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite AthletesSafety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes · Enhanced Emirates Limited	Not applicable	Enrolling by invitation	May 6, 2026
Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled TrialCrohn Disease (CD), Ulcerative Colitis (UC) · Imperial College London	Phase 2	Not yet recruiting	Dec 22, 2025
Cognitive Strategies in Early Psychosis 2Psychosis, Schizophrenia Disorder · University of Minnesota	Phase 3	Recruiting	Dec 4, 2025
Cognitive Strategies in Early Psychosis 1Cognition, Healthy Participants · University of Minnesota	Phase 3	Recruiting	Nov 17, 2025
MODAFIMS: A Trial to Evaluate Predictors of Response to MODAFinil in Patients With Multiple SclerosisMultiple Sclerosis, Cognitive Impairment · Clinical Academic Center (2CA-Braga)	Phase 2	Recruiting	Sep 19, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 24, 1998	ProvigilNDA 20717 · New molecular entity	Nuvo Pharms	29	Marketed
Jul 16, 2012	ModafinilANDA 76594	Natco Pharma	2	Discontinued
Sep 26, 2012	ModafinilANDA 78963	Orbion Pharms	1	Marketed
Sep 26, 2012	ModafinilANDA 90543	Hikma Pharms	0	Discontinued
Sep 27, 2012	ModafinilANDA 202566	Aurobindo Pharma Ltd	2	Marketed
Oct 18, 2012	ModafinilANDA 202700	Alembic	1	Marketed
Nov 1, 2012	ModafinilANDA 76715	Watson Labs Inc	1	Discontinued
Feb 3, 2014	ModafinilANDA 77667	Apotex	3	Marketed
Aug 16, 2017	ModafinilANDA 207196	Appco	1	Marketed
Sep 14, 2017	ModafinilANDA 209966	Cadila	0	Marketed
Sep 3, 2026	ModafinilANDA 208343	Lupin	0	Marketed
—	ModafinilANDA 76596	Teva Pharms	0	Discontinued
—	ModafinilANDA 76597	Barr	0	Discontinued
—	ModafinilANDA 76935	Sandoz	0	Discontinued
—	ModafinilANDA 77892	Caraco	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA