Active substance
Ramelteon
- US FDA 12
- US price lines 2
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ROZEREM | 8MG | tablet · oral | TAKEDA PHARMS USA | Prescription | 22 Jul 2005 |
| RAMELTEON | 8MG | tablet · oral | DR REDDYS LABS SA | Prescription | 26 Jul 2013 |
| RAMELTEON | 8MG | tablet · oral | ACTAVIS LABS FL INC | Prescription | 19 Aug 2015 |
| RAMELTEON | 8MG | tablet · oral | ZYDUS PHARMS | Prescription | 22 Jul 2019 |
| RAMELTEON | 8MG | tablet · oral | PHARMAZONE | Prescription | 10 Apr 2020 |
| RAMELTEON | 8MG | tablet · oral | APPCO | Prescription | 26 Oct 2020 |
| RAMELTEON | 8MG | tablet · oral | ANDAS 5 HOLDING | Prescription | 24 Aug 2022 |
| RAMELTEON | 8MG | tablet · oral | XIROMED | Prescription | 25 Nov 2022 |
| RAMELTEON | 8MG | tablet · oral | MICRO LABS | Prescription | 9 Feb 2023 |
| RAMELTEON | 8MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 10 Jul 2023 |
| RAMELTEON | 8MG | tablet · oral | ADAPTIS | Prescription | 4 Jun 2026 |
| RAMELTEON | 8MG | tablet · oral | GRANULES | Discontinued | 21 Aug 2020 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | RAMELTEON 8 MG TABLET | $0.65983 | per EA | 7 Oct 2026 |
| US NADAC | ROZEREM 8 MG TABLET | $12.41691 | 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
- US FDA 21 Dec 2018 ROZEREM — safety-related labeling change
Labeling sections changed: 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.