Armodafinil

For excessive sleepiness associated with obstructive sleep apnea (OSA). Sold as Nuvigil. Every FDA application for this active ingredient: 1 branded and 7 generic.

As of Nov 14, 2026, FDA lists 8 applications for Armodafinil (sold as Nuvigil), first approved Jun 15, 2007, with 0 new uses approved and 0 published complete response letters.

First approved: Jun 15, 2007
Applications: 8
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $13.2M

Medicare Spending

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


Armodafinil	Part D	$10.0M	+13%	23,466
Nuvigil	Part D	$3.2M	-8%	365

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

ARMODAFINIL 150 MG TABLET: $0.801 per unitGeneric · -3% in a year
ARMODAFINIL 200 MG TABLET: $0.793 per unitGeneric · -9% in a year
ARMODAFINIL 250 MG TABLET: $0.875 per unitGeneric · -9% in a year
ARMODAFINIL 50 MG TABLET: $0.296 per unitGeneric · -10% in a year
NUVIGIL 150 MG TABLET: $34.75 per unitBrand · 0% in a year
NUVIGIL 200 MG TABLET: $35.06 per unitBrand · +1% in a year
NUVIGIL 250 MG TABLET: $34.70 per unitBrand · 0% in a year

Clinical Trials

1 open or ongoing study names this ingredient as an intervention, including as a comparator; newest first. See all

Study	Phase	Status	Posted
WAKIX® (Pitolisant) Pregnancy RegistryPregnancy Related, Narcolepsy · Harmony Biosciences Management, Inc.	—	Recruiting	Sep 10, 2022

Applications

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


Jun 15, 2007	NuvigilNDA 21875 · New formulation or manufacturer	Nuvo Pharms	12	Marketed
Aug 29, 2012	ArmodafinilANDA 200156	Watson Labs Inc	1	Discontinued
Nov 28, 2016	ArmodafinilANDA 200751	Lupin	2	Discontinued
Nov 28, 2016	ArmodafinilANDA 202768	Natco Pharma Ltd	2	Marketed
Mar 6, 2018	ArmodafinilANDA 206069	Aurobindo Pharma Ltd	0	Marketed
Mar 25, 2019	ArmodafinilANDA 201514	Macleods Pharms	0	Marketed
May 9, 2019	ArmodafinilANDA 200043	Mylan Pharms Inc	3	Marketed
—	ArmodafinilANDA 200152	Teva Pharms USA Inc	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