Active substance
Modafinil
- US FDA 11
- Health Canada 7
- US price lines 4
- NHS prices 2
- Safety 5
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PROVIGIL | 100MG; 200MG | tablet · oral | NUVO PHARMS | Prescription | 24 Dec 1998 |
| MODAFINIL | 100MG; 200MG | tablet · oral | ORBION PHARMS | Prescription | 26 Sep 2012 |
| MODAFINIL | 100MG; 200MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 27 Sep 2012 |
| MODAFINIL | 100MG; 200MG | tablet · oral | ALEMBIC | Prescription | 18 Oct 2012 |
| MODAFINIL | 100MG; 200MG | tablet · oral | APOTEX | Prescription | 3 Feb 2014 |
| MODAFINIL | 100MG; 200MG | tablet · oral | APPCO | Prescription | 16 Aug 2017 |
| MODAFINIL | 100MG; 200MG | tablet · oral | CADILA | Prescription | 14 Sep 2017 |
| MODAFINIL | 100MG; 200MG | tablet · oral | LUPIN | Prescription | 3 Sep 2026 |
| MODAFINIL | 100MG; 200MG | tablet · oral | NATCO PHARMA | Discontinued | 16 Jul 2012 |
| MODAFINIL | 100MG; 200MG | tablet · oral | HIKMA PHARMS | Discontinued | 26 Sep 2012 |
| MODAFINIL | 100MG; 200MG | tablet · oral | WATSON LABS INC | Discontinued | 1 Nov 2012 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ALERTEC | 02239665 | 100 MG | TABLET · ORAL | NEURAXPHARM PHARMACEUTICALS, S.L. |
| APO-MODAFINIL | 02285398 | 100 MG | TABLET · ORAL | APOTEX INC |
| AURO-MODAFINIL | 02430487 | 100 MG | TABLET · ORAL | AURO PHARMA INC |
| JAMP MODAFINIL | 02503727 | 100 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| MAR-MODAFINIL | 02432560 | 100 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
| MODAFINIL | 02530244 | 100 MG | TABLET · ORAL | SANIS HEALTH INC |
| TEVA-MODAFINIL | 02420260 | 100 MG | TABLET · ORAL | TEVA CANADA LIMITED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | MODAFINIL 100 MG TABLET | $0.24793 | per EA | 23 Sep 2026 |
| US NADAC | MODAFINIL 200 MG TABLET | $0.34362 | per EA | 23 Sep 2026 |
| US NADAC | PROVIGIL 100 MG TABLET | $53.1528 | per EA | 23 Sep 2026 |
| US NADAC | PROVIGIL 200 MG TABLET | $80.34944 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Modafinil 100mg tablets | £2.41 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Modafinil 200mg tablets | £6.48 | 30 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- MHRA 16 Nov 2020 Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy
Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil. - EMA PRAC 11 Apr 2019 PRAC signal: Evaluation of data on foetal outcomes including congenital anomalies from a single observational study in the US
Action for MAH: update of the product information: Yes - EMA PRAC 14 Feb 2019 PRAC signal: Evaluation of data on foetal outcomes including congenital anomalies from a single observational study in the US
Action for MAH: update of the product information: No - MHRA 11 Dec 2014 Modafinil (Provigil): now restricted to narcolepsy
Further information is available to support safer use - MHRA 11 Dec 2014 Modafinil: restricted use recommended
European Medicines Agency has recommends the use of modafinil should be restricted to treat only sleepiness associated with narcolepsy - should no longer be used for obstructive sleep apnoea or chronic shift work sleep disorder.
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.