Viewing data from:

PROVIGIL

NDA

MODAFINIL | N020717 | NUVO PHARMACEUTICALS (IRELAND) DAC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Appco Pharma LLC FDA-2026-P-6706 · 6 docket documents Appco Pharma LLC filed a citizen petition requesting that the FDA establish that pharmaceutical manufacturing of a drug product is suitable for an Abbreviated New Drug Application under 21 CFR 320.1. The petition seeks regulatory guidance on the suitability of the manufacturing process and facilitie	Suitability	2026-06-11	Open	Appco Pharma LLC
Citizen Petition from Public Citizen’s Health Research Group FDA-2025-P-1449 · 20 docket documents Public Citizen's Health Research Group filed this petition under the Federal Food, Drug, and Cosmetic Act sections 352 and 505(o)(4) requesting that the FDA contraindicate modafinil (PROVIGIL and generics) and armodafinil (NUVIGIL and generics) during pregnancy and in females of reproductive potenti	Other	2025-05-29	Open	Public Citizen’s Health Research Group

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

137 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 96 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Orthostatic Intolerance NCT00262470	Phase 1/2	Active	Satish R. Raj	150	1997-04 → 2029-12
Modafinil and Cognitive Function in POTS NCT01988883	Early Phase 1	Active	Vanderbilt University Medical Center	20	2014-10 → 2026-12
Modafinil to Improve Fatiguability NCT05333250	Phase 1/2	Recruiting	Ottawa Hospital Research Institute	40	2026-03-16 → 2028-03
Cognitive Strategies in Early Psychosis 2 NCT07263022	Phase 3	Recruiting	University of Minnesota	24	2026-07-17 → 2030-04-30
Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)NCT00943176	Phase 1	Completed	Mayo Clinic	40	2009-06 → 2011-04
Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior NCT00368290	Phase 2	Completed	Kyle Kampman	94	2006-09 → 2013-01
Effects of Modafinil in Methamphetamine Dependence NCT00751023	Phase 4	Completed	Medical University of South Carolina	40	2009-02 → 2010-07
Brain Imaging Study of the Effects of Modafinil in Cocaine Addiction NCT00701532	Phase 3	Completed	Assistance Publique - Hôpitaux de Paris	29	2009-04 → 2013-01
Medications for Stopping Cocaine Dependence and Preventing Relapse NCT00218023	Phase 2	Completed	The University of Texas Health Science Center, Houston	101	2006-03 → 2012-04
Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia NCT00772005	Phase 2	Completed	Cephalon	287	2008-09 → 2010-05

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 6 NDCs (4 brand, 2 generic)

Highest NADAC/Unit

$80.33

per ea

Lowest NADAC/Unit

$0.2420

per ea

Brand NDCs

Generic NDCs

Avg Brand: $66.74

Avg Generic: $0.2951

100% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
63459020130PROVIGIL 200 MG TABLET	$80.33	EA	Brand	$0.3483	2026-08-19
60505485203PROVIGIL 200 MG TABLET	$80.33	EA	Brand	$0.3483	2026-08-19
63459010130PROVIGIL 100 MG TABLET	$53.15	EA	Brand	$0.2420	2026-08-19
60505485103PROVIGIL 100 MG TABLET	$53.15	EA	Brand	$0.2420	2026-08-19
55253080290MODAFINIL 200 MG TABLET	$0.3483	EA	Generic	—	2026-08-19
55253080130MODAFINIL 100 MG TABLET	$0.2420	EA	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 14 NDCs (7 FSS, 7 Big4)

Lowest Price

$37.08

Highest Price

$1893.44

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60505-4851-03PROVIGIL 100MG TAB	$1121.65	Big4	Apotex Corporation	09/14/2029
60505-4851-03PROVIGIL 100MG TAB	$1253.14	FSS	Apotex Corporation	09/14/2029
60505-4852-03PROVIGIL 200MG TAB	$1694.25	Big4	Apotex Corporation	09/14/2029
60505-4852-03PROVIGIL 200MG TAB	$1893.44	FSS	Apotex Corporation	09/14/2029
55253-0801-30MODAFINIL 100MG TAB	$70.93	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
55253-0801-30MODAFINIL 100MG TAB	$117.92	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026

Showing 6 of 14 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Provigil (2024)

Total Spending

$13.2M

Total Claims

2,880

Beneficiaries

494

Avg Cost/Unit

$72.95

Spending Trend

$18.2M(2019)→$17.5M(2020)→$16.6M(2021)→$14.5M(2022)→$13.2M(2023)→$13.2M(2024)

YoY Change:-0.2%

5yr CAGR:+5.9%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs4 inactive

10 active API suppliers hold Drug Master Files for this ingredient.

CEPHALON INCMODAFINIL DRUG SUBSTANCE

DMF 119701996

WAVELENGTH ENTERPRISES LTDMODAFINIL

DMF 161402002

DIPHARMA FRANCIS SRLMODAFINIL USP

DMF 162502002

MATRIX PHARMACORP PRIVATE LTDMODAFINIL USP

DMF 163062002

TAPI NL BVMODAFINIL

DMF 163102002

ALEMBIC PHARMACEUTICALS LTDMODAFINIL USP

DMF 164772003

ORBION PHARMACEUTICALS PRIVATE LTDMODAFINIL

DMF 196452006

APITORIA PHARMA PRIVATE LTDMODAFINIL USP (NON-STERILE DRUG SUBSTANCE)

DMF 238982010

CHROMO LABORATORIES INDIA PRIVATE LTDMODAFINIL USP

DMF 369752022

SYMED LABS LTDMODAFINIL USP

DMF 385332023

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMODAFINIL

DMF 175452004

HAS HEALTHCARE ADVANCED SYNTHESIS SAInactiveMODAFINIL

DMF 178152004

FLAMMA SPAInactiveMODAFINIL

DMF 180622005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveMODAFINIL

DMF 184112005

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Jan 20, 2015	SUPPL -38	View Letter (PDF)
Jan 20, 2015	SUPPL -37	View Letter (PDF)
Jan 19, 2012	SUPPL -41	View Letter (PDF)
Jan 19, 2012	SUPPL -40	View Letter (PDF)
Oct 25, 2010	SUPPL -30	View Letter (PDF)
Oct 25, 2010	SUPPL -34	View Letter (PDF)
Oct 25, 2010	SUPPL -36	View Letter (PDF)
Aug 22, 2007	SUPPL -20	View Letter (PDF)
Feb 2, 2004	SUPPL -8	View Letter (PDF)
Aug 15, 2003	SUPPL -9	View Letter (PDF)
May 29, 2003	SUPPL -6	View Letter (PDF)
Dec 24, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 24, 1998

No patent or exclusivity listings for this strength.

#002 — 200MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Dec 24, 1998