SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| Darista | 600 mg | Film-coated tablet · Oral use | 60 Tablet Container | SAR 1721.40 | Generic · Prescription | Aurobindo Pharma Saudi Arabia Limited | Valid |
| Darista | 400 mg | Film-coated tablet · Oral use | 60 Tablet Container | SAR 1080.60 | Generic · Prescription | Aurobindo Pharma Saudi Arabia Limited | Valid |
| Dunarez | 400 mg | Film-coated tablet · Oral use | 30 Bottle | SAR 501.70 | Generic · Prescription | SUDAIR PHARMA COMPANY | Valid |
| Dunarez | 600 mg | Film-coated tablet · Oral use | 30 Bottle | SAR 803.85 | Generic · Prescription | SUDAIR PHARMA COMPANY | Valid |
| PREZISTA 400 mg film-coated tablet | 400 mg | Film-coated tablet · Oral use | 60 Tablet Container | SAR 1157.75 | NCE · Prescription | Janssen-Cilag International NV | Valid |
| PREZISTA 600 mg film-coated tablet | 600 mg | Film-coated tablet · Oral use | 60 Tablet Container | SAR 1855.05 | NCE · Prescription | JANSSEN PHARMACEUTICA N.V | Valid |
| PREZISTA 300MG F.C. TABLETS | 300 mg | Film-coated tablet · Oral use | 120 Blister | SAR 1884.65 | NCE · Prescription | JANSSEN-CILAG | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
HUMAN IMMUNODEFICIENCY VIRUS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| PREZISTA | 600MG; 75MG; 150MG; 800MG | tablet · oral | JANSSEN PRODS | Prescription | 23 Jun 2006 |
| PREZISTA | 100MG/ML | suspension · oral | JANSSEN PRODS | Prescription | 16 Dec 2011 |
| DARUNAVIR | 600MG; 800MG | tablet · oral | LUPIN | Prescription | 29 Sep 2022 |
| DARUNAVIR | 400MG; 600MG | tablet · oral | HETERO LABS LTD III | Prescription | 14 Sep 2023 |
| DARUNAVIR | 600MG; 800MG | tablet · oral | CIPLA | Prescription | 28 Nov 2023 |
| DARUNAVIR | 600MG; 800MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 28 Nov 2023 |
| DARUNAVIR | 600MG; 800MG | tablet · oral | DR REDDYS | Prescription | 28 Nov 2023 |
| DARUNAVIR | 600MG; 800MG | tablet · oral | MSN | Prescription | 28 Nov 2023 |
| DARUNAVIR | 600MG; 800MG | tablet · oral | AMNEAL | Prescription | 8 Dec 2023 |
| DARUNAVIR | 600MG; 800MG | tablet · oral | ZYDUS LIFESCIENCES | Prescription | 13 Dec 2023 |
| DARUNAVIR | 600MG; 800MG | tablet · oral | ANNORA PHARMA | Prescription | 21 Jan 2025 |
| DARUNAVIR | 75MG; 150MG; 300MG; 400MG; 600MG | tablet · oral | MYLAN | Prescription | 22 Jul 2025 |
| PREZISTA | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | JANSSEN PRODS | Discontinued | 23 Jun 2006 |
| DARUNAVIR | 600MG | tablet · oral | TEVA PHARMS USA | Discontinued | 21 Nov 2017 |
EMA European Union — centrally authorised medicines
Prezista Janssen-Cilag International NV · Authorised · authorised 11 Feb 2007 · ATC J05AE10
Therapeutic indication (EMA)
PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adult and paediatric patients from the age of 3 years and at least 15 kg body weight. PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). In deciding to initiate treatment with PREZISTA co administered with cobicistat or low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA. PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection. PREZISTA 75 mg, 150 mg, and 600 mg tablets may be used to provide suitable dose regimens: For the treatment of HIV 1 infection in antiretroviral treatment (ART) experienced adult patients, including those that have been highly pre treated. For the treatment of HIV 1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. In deciding to initiate treatment with PREZISTA co administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of PREZISTA. PREZISTA, co administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV 1) infection. PREZISTA, co administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg). PREZISTA 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV 1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART) naïve. ART experienced with no darunavir resistance associated mutations (DRV RAMs) and who have plasma HIV 1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 106/L. In deciding to initiate treatment with PREZISTA in such ART experienced patients, genotypic testing should guide the use of PREZISTA.
Therapeutic indication (EMA)
Darunavir, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection (see section 4.2). Darunavir Viatris 75 mg, 150 mg, 300 mg and 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated. For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir (see sections 4.2, 4.4 and 5.1). Darunavir co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and adolescents (aged 12 years and older, weighing at least 40 kg) (see section 4.2). Darunavir Viatris 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2). ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 10?/L. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).
Darunavir Krka KRKA, d.d., Novo mesto · Authorised · authorised 26 Jan 2018 · ATC J05AE10
Therapeutic indication (EMA)
400 and 800 mg Darunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir Krka 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2). ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1). 600 mg Darunavir Krka, co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir Krka 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated. For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.
Darunavir Krka d.d. KRKA, d.d., Novo mesto · Expired · authorised 18 Jan 2018 · ATC J05AE10
Therapeutic indication (EMA)
400mg and 800 mg Film-coated Tablets Darunavir Krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir Krka d.d., co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2). Darunavir Krka d.d. 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2). ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ? 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1). 600mg Film-coated Tablets Darunavir Krka d.d., co-administered with low dose ritonavir is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection. Darunavir Krka d.d. 600 mg tablets may be used to provide suitable dose regimens (see section 4.2): For the treatment of HIV-1 infection in antiretroviral treatment (ART)-experienced adult patients, including those that have been highly pre-treated. For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least 15 kg body weight. In deciding to initiate treatment with darunavir co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | DARUNAVIR 600 MG TABLET | $1.16284 | per EA | 23 Sep 2026 |
| US NADAC | DARUNAVIR 800 MG TABLET | $2.38195 | per EA | 23 Sep 2026 |
| US NADAC | PREZISTA 600 MG TABLET | $34.89014 | per EA | 23 Sep 2026 |
| US NADAC | PREZISTA 800 MG TABLET | $70.10727 | 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.
WHO WHO Model List of Essential Medicines (2025)
- 6.4.2.3. Antiretrovirals > Protease inhibitors · core
Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
Oral > Solid: 75 mg; 400 mg (EML); 600 mg (EML); 800 mg (EML)
Safety signals and safety-related labeling changes
- US FDA 27 Feb 2026 PREZCOBIX — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 31 Mar 2023 PREZISTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 31 Mar 2023 PREZISTA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 31 Mar 2023 SYMTUZA — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes - EMA PRAC 8 Mar 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
All safety entries for darunavir →
Combinations containing Darunavir
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.