US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| RILUZOLE | 50MG | tablet · oral | IMPAX LABS | Prescription | 29 Jan 2003 |
| RILUZOLE | 50MG | tablet · oral | GLENMARK PHARMS LTD | Prescription | 18 Jun 2013 |
| RILUZOLE | 50MG | tablet · oral | ALKEM LABS LTD | Prescription | 30 Mar 2016 |
| TIGLUTIK KIT | 50MG/10ML | suspension · oral | ITALFARMACO SA | Prescription | 5 Sep 2018 |
| RILUZOLE | 50MG | tablet · oral | KENTON | Prescription | 9 Dec 2019 |
| RILUZOLE | 50MG/10ML | suspension · oral | ALKEM LABS LTD | Prescription | 22 Aug 2024 |
| RILUTEK | 50MG | tablet · oral | AZURITY | Discontinued | 12 Dec 1995 |
| RILUZOLE | 50MG | tablet · oral | APOTEX CORP | Discontinued | 18 Jun 2013 |
| RILUZOLE | 50MG | tablet · oral | SUN PHARM INDS LTD | Discontinued | 18 Jun 2013 |
| RILUZOLE | 50MG | tablet · oral | PHARMOBEDIENT | Discontinued | 1 Jul 2013 |
| RILUZOLE | 50MG | tablet · oral | DAITO PHARMS CO LTD | Discontinued | 16 Oct 2018 |
| EXSERVAN | 50MG | film · oral | AQUESTIVE | Discontinued | 22 Nov 2019 |
EMA European Union — centrally authorised medicines
Rilutek Sanofi Winthrop Industrie · Authorised · authorised 10 Jun 1996 · ATC N07XX02
Therapeutic indication (EMA)
Rilutek is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Rilutek extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Rilutek exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Rilutek has not been shown to be effective in the late stages of ALS. Safety and efficacy of Rilutek has only been studied in ALS. Therefore, Rilutek should not be used in patients with any other form of motor-neurone disease.
Riluzole Zentiva Zentiva k.s. · Authorised · authorised 7 May 2012 · ATC N07XX02
Therapeutic indication (EMA)
Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS). Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS. Survival was defined as patients who were alive, not intubated for mechanical ventilation and tracheotomy-free. There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms. Riluzole Zentiva has not been shown to be effective in the late stages of ALS. Safety and efficacy of Riluzole Zentiva has only been studied in ALS. Therefore, Riluzole Zentiva should not be used in patients with any other form of motor-neurone disease.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| APO-RILUZOLE | 02352583 | 50 MG | TABLET · ORAL | APOTEX INC |
| MYLAN-RILUZOLE | 02390299 | 50 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| RILUTEK | 02242763 | 50 MG | TABLET · ORAL | SANOFI-AVENTIS CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | RILUZOLE 50 MG TABLET | $0.29336 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Riluzole 25mg/5ml oral suspension sugar free | £100.00 | 300 ml | 1 Oct 2026 |
| NHS Drug Tariff | Riluzole 50mg orodispersible films | £168.00 | 56 film | 1 Oct 2026 |
| NHS Drug Tariff | Riluzole 50mg tablets | £209.49 | 56 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.
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.