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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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Appco Pharma LLC FDA-2026-P-6706 Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application (ANDA) for Modafinil Tablets, USP in 50 mg and 150 mg strengths, which differ from the Reference Listed Drug P	Suitability	2026-06-11	Open	Appco Pharma LLC

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Provigil (2023)

Total Spending

$13.2M

Total Claims

2,876

Beneficiaries

509

Avg Cost/Unit

$73.10

Spending Trend

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

YoY Change:+3.7%

5yr CAGR:+7.7%

Source: CMS Medicare Part D Spending by Drug (2023). 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