Latuda Aziende Chimiche Riunite Angelini Francesco S.p.A. · Authorised · authorised 21 Mar 2014 · ATC N05AE05
Therapeutic indication (EMA)
Treatment of schizophrenia in adults aged 18 years and over.
Active substance
Lurasidone
- SFDA 17
- US FDA 21
- EMA 1
- Health Canada 33
- US price lines 10
- NHS prices 3
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Debilur | 80 mg | Film-coated tablet · Oral use | 30 Blister | SAR 206.60 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| Debilur | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 206.60 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| Debilur | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 206.60 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| Elbaluran | 120 mg | Film-coated tablet · Oral use | 30 Blister | SAR 179.85 | Generic · Prescription | Apex Pharma | Valid |
| Elbaluran | 80 mg | Film-coated tablet · Oral use | 30 Blister | SAR 179.85 | Generic · Prescription | Apex Pharma | Valid |
| Elbaluran | 60 mg | Film-coated tablet · Oral use | 30 Blister | SAR 179.85 | Generic · Prescription | Apex Pharma | Valid |
| Elbaluran | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 179.85 | Generic · Prescription | Apex Pharma | Valid |
| Elbaluran | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 179.85 | Generic · Prescription | Apex Pharma | Valid |
| LATUDA 20 MG F.C.TABLET | 20 mg | Film-coated tablet · Oral use | 28 Blister | SAR 243.10 | NCE · Prescription | Medius AG | Valid |
| LATUDA 40 MG F.C.TABLET | 40 mg | Film-coated tablet · Oral use | 28 Blister | SAR 243.10 | NCE · Prescription | Medius AG | Valid |
| LATUDA 80 MG F.C.TABLET | 80 mg | Film-coated tablet · Oral use | 28 Blister | SAR 243.10 | NCE · Prescription | Medius AG | Valid |
| Laroza | 120 mg | Film-coated tablet · Oral use | 30 Blister | SAR 196.25 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Laroza | 80 mg | Film-coated tablet · Oral use | 30 Blister | SAR 196.25 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Laroza | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 196.25 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Laroza | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 196.25 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| Novus | 40 mg | Film-coated tablet · Oral use | 30 Blister | SAR 186.45 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
| Novus | 80 mg | Film-coated tablet · Oral use | 30 Blister | SAR 186.45 | Generic · Prescription | MS Pharma Saudi (MSPS) | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| LATUDA | 40MG; 80MG; 20MG; 120MG; 60MG | tablet · oral | SUNOVION PHARMS INC | Prescription | 28 Oct 2010 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | INVAGEN PHARMS | Prescription | 3 Jan 2019 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | LUPIN | Prescription | 3 Jan 2019 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | ACCORD HLTHCARE | Prescription | 3 Jan 2019 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 80MG; 120MG; 60MG | tablet · oral | TORRENT | Prescription | 3 Jan 2019 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG | tablet · oral | SUN PHARM | Prescription | 4 Jan 2019 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | ZYDUS PHARMS | Prescription | 19 Mar 2019 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | HERITAGE PHARMA AVET | Prescription | 4 Sep 2019 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | CHARTWELL RX | Prescription | 28 Dec 2020 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | ALEMBIC | Prescription | 13 May 2021 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG | tablet · oral | DR REDDYS | Prescription | 24 Aug 2021 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | MSN | Prescription | 9 Sep 2022 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | ALKEM LABS LTD | Prescription | 13 Dec 2022 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 10 Mar 2023 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | MACLEODS PHARMS | Prescription | 9 Jun 2023 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | ANNORA PHARMA | Prescription | 21 Aug 2024 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | JUBILANT GENERICS | Prescription | 6 Dec 2024 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | AMNEAL PHARMS CO | Discontinued | 3 Jan 2019 |
| LURASIDONE HYDROCHLORIDE | 120MG | tablet · oral | SUN PHARM | Discontinued | 4 Jan 2019 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | TEVA PHARMS USA | Discontinued | 17 May 2019 |
| LURASIDONE HYDROCHLORIDE | 20MG; 40MG; 60MG; 80MG; 120MG | tablet · oral | WATSON LABS TEVA | Discontinued | 2 Feb 2021 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AURO-LURASIDONE | 02513986 | 20 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-LURASIDONE | 02513994 | 40 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-LURASIDONE | 02514001 | 60 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-LURASIDONE | 02514028 | 80 MG | TABLET · ORAL | AURO PHARMA INC |
| AURO-LURASIDONE | 02514036 | 120 MG | TABLET · ORAL | AURO PHARMA INC |
| JAMP LURASIDONE | 02516438 | 20 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP LURASIDONE | 02516446 | 40 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP LURASIDONE | 02516454 | 60 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP LURASIDONE | 02516462 | 80 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP LURASIDONE | 02516470 | 120 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| LURASIDONE | 02548585 | 20 MG | TABLET · ORAL | SANIS HEALTH INC |
| LURASIDONE | 02548593 | 40 MG | TABLET · ORAL | SANIS HEALTH INC |
| LURASIDONE | 02548607 | 60 MG | TABLET · ORAL | SANIS HEALTH INC |
| LURASIDONE | 02548615 | 80 MG | TABLET · ORAL | SANIS HEALTH INC |
| NRA-LURASIDONE | 02522314 | 20 MG | TABLET · ORAL | NORA PHARMA INC |
| NRA-LURASIDONE | 02522322 | 40 MG | TABLET · ORAL | NORA PHARMA INC |
| NRA-LURASIDONE | 02522330 | 60 MG | TABLET · ORAL | NORA PHARMA INC |
| NRA-LURASIDONE | 02522349 | 80 MG | TABLET · ORAL | NORA PHARMA INC |
| PMS-LURASIDONE | 02505878 | 20 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-LURASIDONE | 02505886 | 40 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-LURASIDONE | 02505894 | 60 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-LURASIDONE | 02505908 | 80 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-LURASIDONE | 02505916 | 120 MG | TABLET · ORAL | PHARMASCIENCE INC |
| SANDOZ LURASIDONE | 02521075 | 20 MG | TABLET · ORAL | SANDOZ CANADA INCORPORATED |
| SANDOZ LURASIDONE | 02521091 | 40 MG | TABLET · ORAL | SANDOZ CANADA INCORPORATED |
8 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | LATUDA 120 MG TABLET | $69.27954 | per EA | 23 Sep 2026 |
| US NADAC | LATUDA 20 MG TABLET | $46.45672 | per EA | 23 Sep 2026 |
| US NADAC | LATUDA 40 MG TABLET | $47.11307 | per EA | 23 Sep 2026 |
| US NADAC | LATUDA 60 MG TABLET | $46.81093 | per EA | 23 Sep 2026 |
| US NADAC | LATUDA 80 MG TABLET | $46.36946 | per EA | 23 Sep 2026 |
| US NADAC | LURASIDONE HCL 120 MG TABLET | $0.48665 | per EA | 23 Sep 2026 |
| US NADAC | LURASIDONE HCL 20 MG TABLET | $0.14167 | per EA | 23 Sep 2026 |
| US NADAC | LURASIDONE HCL 40 MG TABLET | $0.20953 | per EA | 23 Sep 2026 |
| US NADAC | LURASIDONE HCL 60 MG TABLET | $0.29118 | per EA | 23 Sep 2026 |
| US NADAC | LURASIDONE HCL 80 MG TABLET | $0.3278 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Lurasidone 18.5mg tablets | £46.45 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Lurasidone 37mg tablets | £45.71 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Lurasidone 74mg tablets | £54.27 | 28 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
- US FDA 22 Jan 2025 LATUDA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 11 Jun 2015 PRAC signal: Acute renal failure
Action for MAH: update of the product information: No - EMA PRAC 6 Nov 2014 PRAC signal: Acute renal failure
Action for MAH: update of the product information: No
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.