Active substance
Clozapine
- SFDA 10
- US FDA 18
- Health Canada 17
- US price lines 10
- NHS prices 5
- WHO EML 1
- Safety 12
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| LEPONEX 100MG TAB | 100 mg | Tablet · Oral use | 50 Blister | SAR 145.15 | NCE · Prescription | Viatris Pharma GmbH | Valid |
| LEPONEX 25MG TAB | 25 mg | Tablet · Oral use | 50 Blister | SAR 47.10 | NCE · Prescription | Viatris Pharma GmbH | Valid |
| Zapnex | 100 mg | Tablet · Oral use | 50 Blister | SAR 109.25 | Generic · Prescription | Aurobindo Pharma Limited | Valid |
| Zapnex | 25 mg | Tablet · Oral use | 50 Blister | SAR 35.45 | Generic · Prescription | Aurobindo Pharma Limited | Valid |
| LEPONEX 100MG TAB | 100 mg | Tablet · Oral use | 50 Blister | SAR 156.10 | NCE · Prescription | NOVARTIS PHARMA AG | Withdrawn by MAH · Not Marketed |
| LEPONEX 100MG TAB | 100 mg | Tablet · Oral use | 50 Blister | SAR 156.10 | NCE · Prescription | BGP products GmbH | Withdrawn by MAH · Not Marketed |
| LEPONEX 100MG TAB | 100 mg | Tablet · Oral use | 50 Blister | SAR 156.10 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
| LEPONEX 25MG TAB | 25 mg | Tablet · Oral use | 50 Blister | SAR 50.65 | NCE · Prescription | NOVARTIS PHARMA AG | Withdrawn by MAH · Not Marketed |
| LEPONEX 25MG TAB | 25 mg | Tablet · Oral use | 50 Blister | SAR 50.65 | NCE · Prescription | BGP products GmbH | Withdrawn by MAH · Not Marketed |
| LEPONEX 25MG TAB | 25 mg | Tablet · Oral use | 50 Blister | SAR 50.65 | NCE · Prescription | NOVARTIS | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ACUTE MANIA; ALZHEIMER / DEMENTIA; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); BIPOLAR I DISORDER MAINTENANCE; SCHIZOPHRENIA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CLOZARIL | 25MG; 100MG | tablet · oral | HERITAGE LIFE | Prescription | 26 Sep 1989 |
| CLOZAPINE | 25MG; 100MG; 12.5MG; 50MG | tablet · oral | IVAX SUB TEVA PHARMS | Prescription | 26 Nov 1997 |
| CLOZAPINE | 25MG; 100MG; 50MG; 200MG | tablet · oral | MYLAN | Prescription | 27 May 1999 |
| CLOZAPINE | 200MG; 100MG; 50MG | tablet · oral | IVAX SUB TEVA PHARMS | Prescription | 16 Dec 2005 |
| VERSACLOZ | 50MG/ML | suspension · oral | DOUGLAS PHARMS | Prescription | 6 Feb 2013 |
| CLOZAPINE | 25MG; 100MG; 150MG; 200MG | tablet, orally disintegrating · oral | MYLAN | Prescription | 15 Sep 2015 |
| CLOZAPINE | 25MG; 100MG; 12.5MG; 150MG; 200MG | tablet, orally disintegrating · oral | BARR LABS INC | Prescription | 25 Nov 2015 |
| CLOZAPINE | 25MG; 100MG | tablet · oral | ACCORD HLTHCARE | Prescription | 25 Nov 2015 |
| CLOZAPINE | 25MG; 50MG; 100MG; 200MG | tablet · oral | AUROBINDO PHARMA | Prescription | 29 Nov 2016 |
| CLOZAPINE | 12.5MG; 25MG; 100MG; 150MG; 200MG | tablet, orally disintegrating · oral | AUROBINDO PHARMA | Prescription | 12 Dec 2024 |
| CLOZARIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | HERITAGE LIFE | Discontinued | 26 Sep 1989 |
| CLOZAPINE | 25MG; 100MG | tablet · oral | SANDOZ | Discontinued | 30 Aug 1996 |
| CLOZAPINE | 12.5MG | tablet · oral | MYLAN | Discontinued | 27 May 1999 |
| CLOZAPINE | 25MG; 100MG; 50MG; 200MG | tablet · oral | SUN PHARM INDS INC | Discontinued | 15 Nov 2002 |
| FAZACLO ODT | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet, orally disintegrating · oral | JAZZ | Discontinued | 10 Feb 2004 |
| CLOZAPINE | 25MG; 100MG | tablet · oral | PAR PHARM | Discontinued | 26 Apr 2005 |
| CLOZAPINE | 25MG; 100MG; 50MG; 200MG | tablet · oral | DR REDDYS LABS SA | Discontinued | 17 Sep 2015 |
| CLOZAPINE | 25MG; 50MG; 100MG; 200MG | tablet · oral | ZYDUS PHARMS | Discontinued | 6 Dec 2017 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AA-CLOZAPINE | 02248034 | 25 MG | TABLET · ORAL | AA PHARMA INC |
| AA-CLOZAPINE | 02248035 | 100 MG | TABLET · ORAL | AA PHARMA INC |
| AA-CLOZAPINE | 02458748 | 50 MG | TABLET · ORAL | AA PHARMA INC |
| AA-CLOZAPINE | 02458756 | 200 MG | TABLET · ORAL | AA PHARMA INC |
| CLOZARIL | 00894737 | 25 MG | TABLET · ORAL | HLS THERAPEUTICS INC |
| CLOZARIL | 00894745 | 100 MG | TABLET · ORAL | HLS THERAPEUTICS INC |
| CLOZARIL | 02490668 | 50 MG | TABLET · ORAL | HLS THERAPEUTICS INC |
| CLOZARIL | 02490676 | 200 MG | TABLET · ORAL | HLS THERAPEUTICS INC |
| GEN-CLOZAPINE | 02247243 | 25 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| GEN-CLOZAPINE | 02247244 | 100 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| GEN-CLOZAPINE | 02305003 | 50 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| GEN-CLOZAPINE | 02305011 | 200 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| GEN-CLOZAPINE | 02554631 | 12.5 MG | TABLET (ORALLY-DISINTEGRATING) · ORAL | MYLAN PHARMACEUTICALS ULC |
| GEN-CLOZAPINE | 02554658 | 25 MG | TABLET (ORALLY-DISINTEGRATING) · ORAL | MYLAN PHARMACEUTICALS ULC |
| GEN-CLOZAPINE | 02554666 | 50 MG | TABLET (ORALLY-DISINTEGRATING) · ORAL | MYLAN PHARMACEUTICALS ULC |
| GEN-CLOZAPINE | 02554674 | 100 MG | TABLET (ORALLY-DISINTEGRATING) · ORAL | MYLAN PHARMACEUTICALS ULC |
| GEN-CLOZAPINE | 02554682 | 200 MG | TABLET (ORALLY-DISINTEGRATING) · ORAL | MYLAN PHARMACEUTICALS ULC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | CLOZAPINE 100 MG TABLET | $0.61031 | per EA | 23 Sep 2026 |
| US NADAC | CLOZAPINE 200 MG TABLET | $0.96891 | per EA | 23 Sep 2026 |
| US NADAC | CLOZAPINE 25 MG TABLET | $0.24238 | per EA | 23 Sep 2026 |
| US NADAC | CLOZAPINE 50 MG TABLET | $0.54183 | per EA | 23 Sep 2026 |
| US NADAC | CLOZAPINE ODT 100 MG TABLET | $4.26464 | per EA | 23 Sep 2026 |
| US NADAC | CLOZAPINE ODT 150 MG TABLET | $14.97084 | per EA | 19 Aug 2026 |
| US NADAC | CLOZAPINE ODT 200 MG TABLET | $21.20325 | per EA | 23 Sep 2026 |
| US NADAC | CLOZAPINE ODT 25 MG TABLET | $1.65786 | per EA | 23 Sep 2026 |
| US NADAC | CLOZARIL 100 MG TABLET | $16.83316 | per EA | 1 Jun 2026 |
| US NADAC | CLOZARIL 25 MG TABLET | $6.54457 | per EA | 1 Jun 2026 |
| NHS Drug Tariff | Clozapine 100mg tablets | £66.53 | 84 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Clozapine 200mg tablets | £158.40 | 100 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Clozapine 25mg tablets | £16.64 | 84 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Clozapine 50mg tablets | £39.60 | 100 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Clozapine 50mg/ml oral suspension sugar free | £77.73 | 100 ml | 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.
WHO WHO Model List of Essential Medicines (2025)
- 24.1. Medicines for psychotic disorders · complementary
Schizophrenia or other primary psychotic disorders
Oral > Solid: 25 mg; 50 mg; 100 mg; 200 mg
Safety signals and safety-related labeling changes
- EMA PRAC 10 Jul 2025 PRAC signal: New aspect of the known risk of neutropenia/agranulocytosis with potential impact on the risk minimisation measures
Action for MAH: update of the product information: Yes - US FDA 13 Jun 2025 CLOZARIL — 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 - US FDA 13 Jun 2025 VERSACLOZ — 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 13 Feb 2025 PRAC signal: Increased risk of haematological malignancies
Action for MAH: update of the product information: No - EMA PRAC 16 Jan 2025 PRAC signal: Appendicitis
Action for MAH: update of the product information: No - EMA PRAC 16 Jan 2025 PRAC signal: New aspect of the known risk of neutropenia/agranulocytosis with potential impact on the risk minimisation measures
Action for MAH: update of the product information: No - US FDA 14 Apr 2020 FAZACLO ODT — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - MHRA 26 Oct 2017 Clozapine: reminder of potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus
If constipation occurs during treatment with clozapine (Clozaril, Denzapine, Zaponex), it is vital that it is recognised and actively treated. - EMA PRAC 13 May 2016 PRAC signal: Myocarditis
Action for MAH: update of the product information: No - EMA PRAC 10 Sep 2015 PRAC signal: Myocarditis
Action for MAH: update of the product information: No - 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.