Active substance
Dexlansoprazole
- SFDA 10
- US FDA 6
- Health Canada 4
- US price lines 4
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| DEXILANT 30 mg | 30 mg | Prolonged-release capsule · Oral use | 28 Blister | SAR 72.15 | NCE · Prescription | ACINO PHARMA AG | Valid |
| DEXILANT 30 mg | 30 mg | Prolonged-release capsule · Oral use | 14 Blister | SAR 30.55 | NCE · Prescription | ACINO PHARMA AG | Valid |
| DEXILANT 60 mg | 60 mg | Prolonged-release capsule · Oral use | 28 Blister | SAR 98.95 | NCE · Prescription | ACINO PHARMA AG | Valid |
| INSTIGAR 30 mg Delayed-Release Capsule | 30 mg | Modified-release capsule · Oral use | 14 Blister | SAR 30.55 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| INSTIGAR 30 mg Delayed-Release Capsule | 30 mg | Modified-release capsule · Oral use | 28 Blister | SAR 72.15 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| INSTIGAR 60 mg Delayed-Release Capsule | 60 mg | Modified-release capsule · Oral use | 28 Blister | SAR 98.95 | NCE · Prescription | Jazeera Pharmaceutical Industries (JPI) | Valid |
| DEXILANT 30 mg | 30 mg | Modified-release capsule · Oral use | 14 Blister | SAR 47.25 | NCE · Prescription | TAKEDA | Withdrawn by MAH · Not Marketed |
| DEXILANT 30 mg | 30 mg | Modified-release capsule · Oral use | 28 Blister | SAR 82.30 | NCE · Prescription | TAKEDA | Withdrawn by MAH · Not Marketed |
| DEXILANT 60 mg | 60 mg | Prolonged-release capsule · Oral use | 28 Blister | SAR 83.85 | NCE · Prescription | TAKEDA GMBH | Withdrawn by MAH · Not Marketed |
| DEXILANT 60 mg | 60 mg | Modified-release capsule · Oral use | 28 Blister | SAR 111.45 | NCE · Prescription | TAKEDA | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ANESTHESIA-SUPPORTIVE AGENTS/ ASPIRATION PNEUMONIA PROPHYLAXIS; GASTROESOPHAGEAL REFLUX DISEASE (GERD); THROMBOTIC THROMBOCYTOPENIC PURPURA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DEXILANT | 30MG; 60MG | capsule, delayed release · oral | TAKEDA PHARMS USA | Prescription | 30 Jan 2009 |
| DEXLANSOPRAZOLE | 60MG; 30MG | capsule, delayed release · oral | PH HEALTH | Prescription | 19 Apr 2017 |
| DEXLANSOPRAZOLE | 30MG; 60MG | capsule, delayed release · oral | TWI PHARMS | Prescription | 16 Sep 2022 |
| DEXLANSOPRAZOLE | 30MG; 60MG | capsule, delayed release · oral | MYLAN | Prescription | 19 Jan 2024 |
| DEXLANSOPRAZOLE | 30MG; 60MG | capsule, delayed release · oral | ALEMBIC | Prescription | 12 Nov 2025 |
| DEXILANT SOLUTAB | 30MG | tablet, orally disintegrating, delayed release · oral | TAKEDA PHARMS USA | Discontinued | 26 Jan 2016 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-DEXLANSOPRAZOLE | 02528991 | 30 MG | CAPSULE (DELAYED-RELEASE) · NASOGASTRIC; ORAL | APOTEX INC |
| APO-DEXLANSOPRAZOLE | 02529025 | 60 MG | CAPSULE (DELAYED-RELEASE) · NASOGASTRIC; ORAL | APOTEX INC |
| DEXILANT | 02354950 | 30 MG | CAPSULE (DELAYED-RELEASE) · NASOGASTRIC; ORAL | TAKEDA CANADA INC |
| DEXILANT | 02354969 | 60 MG | CAPSULE (DELAYED-RELEASE) · NASOGASTRIC; ORAL | TAKEDA CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DEXILANT DR 30 MG CAPSULE | $9.8526 | per EA | 23 Sep 2026 |
| US NADAC | DEXILANT DR 60 MG CAPSULE | $9.83942 | per EA | 23 Sep 2026 |
| US NADAC | DEXLANSOPRAZOLE DR 30 MG CAP | $3.77267 | per EA | 23 Sep 2026 |
| US NADAC | DEXLANSOPRAZOLE DR 60 MG CAP | $3.70686 | 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 18 Jul 2023 DEXILANT — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 9 Feb 2017 PRAC signal: Unexpected histopathological findings from a juvenile rat toxicity study
Action for MAH: update of the product information: No - US FDA 24 Oct 2016 DEXILANT SOLUTAB — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 29 Sep 2016 PRAC signal: Unexpected histopathological findings from a juvenile rat toxicity study
Action for MAH: update of the product information: No - EMA PRAC 13 May 2016 PRAC signal: Unexpected histopathological findings from a juvenile rat toxicity study
Action for MAH: update of the product information: No - EMA PRAC 9 Jul 2015 PRAC signal: Subacute cutaneous lupus erythematosus (SCLE)
Action for MAH: update of the product information: Yes
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.