Active substance
Armodafinil
- US FDA 8
- US price lines 7
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| NUVIGIL | 50MG; 150MG; 250MG; 200MG | tablet · oral | NUVO PHARMS | Prescription | 15 Jun 2007 |
| ARMODAFINIL | 50MG; 150MG; 250MG; 100MG; 200MG | tablet · oral | MYLAN PHARMS INC | Prescription | 1 Jun 2012 |
| ARMODAFINIL | 50MG; 150MG; 250MG; 100MG; 200MG | tablet · oral | NATCO PHARMA LTD | Prescription | 28 Nov 2016 |
| ARMODAFINIL | 50MG; 150MG; 250MG; 200MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 6 Mar 2018 |
| ARMODAFINIL | 50MG; 150MG; 250MG | tablet · oral | COREPHARMA | Prescription | 25 Mar 2019 |
| NUVIGIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | NUVO PHARMS | Discontinued | 15 Jun 2007 |
| ARMODAFINIL | 100MG; 200MG | tablet · oral | WATSON LABS INC | Discontinued | 29 Aug 2012 |
| ARMODAFINIL | 50MG; 150MG; 200MG; 250MG | tablet · oral | LUPIN | Discontinued | 28 Nov 2016 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ARMODAFINIL 150 MG TABLET | $0.78762 | per EA | 23 Sep 2026 |
| US NADAC | ARMODAFINIL 200 MG TABLET | $0.8028 | per EA | 23 Sep 2026 |
| US NADAC | ARMODAFINIL 250 MG TABLET | $0.90818 | per EA | 23 Sep 2026 |
| US NADAC | ARMODAFINIL 50 MG TABLET | $0.30558 | per EA | 23 Sep 2026 |
| US NADAC | NUVIGIL 150 MG TABLET | $34.752 | per EA | 21 Jan 2026 |
| US NADAC | NUVIGIL 200 MG TABLET | $35.0624 | per EA | 19 Nov 2025 |
| US NADAC | NUVIGIL 250 MG TABLET | $34.77173 | per EA | 23 Sep 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
- 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 - US FDA 7 Feb 2017 NUVIGIL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.