MedPath

Darunavir

Generic Name
Darunavir
Brand Names
Prezcobix, Prezista, Rezolsta, Darunavir Viatris (previously Darunavir Mylan), Darunavir Krka
Drug Type
Small Molecule
Chemical Formula
C27H37N3O7S
CAS Number
206361-99-1
Unique Ingredient Identifier
YO603Y8113

Overview

Darunavir is a protease inhibitor used with other HIV protease inhibitor drugs as well as ritonavir for the effective management of HIV-1 infection. As a second-generation protease inhibitor, darunavir is designed to combat resistance to standard HIV therapy. It was initially approved by the FDA in 2006. Darunavir is being studied as a possible treatment for SARS-CoV-2, the coronavirus responsible for COVID-19, due to in vitro evidence supporting its ability to combat this infection. Clinical trials are underway and are expected to conclude in August 2020.

Background

Darunavir is a protease inhibitor used with other HIV protease inhibitor drugs as well as ritonavir for the effective management of HIV-1 infection. As a second-generation protease inhibitor, darunavir is designed to combat resistance to standard HIV therapy. It was initially approved by the FDA in 2006. Darunavir is being studied as a possible treatment for SARS-CoV-2, the coronavirus responsible for COVID-19, due to in vitro evidence supporting its ability to combat this infection. Clinical trials are underway and are expected to conclude in August 2020.

Indication

Darunavir, co-administered with ritonavir, and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) in children age 3 or above and adults with HIV-1 infection.

Associated Conditions

  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

FDA Approved Products

DARUNAVIR
Manufacturer:Lupin Pharmaceuticals, Inc.
Route:ORAL
Strength:600 mg in 1 1
Approved: 2024/01/03
NDC:68180-345
Darunavir
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:400 mg in 1 1
Approved: 2023/10/05
NDC:31722-567
Darunavir
Manufacturer:Dr.Reddys Laboratories Inc
Route:ORAL
Strength:600 mg in 1 1
Approved: 2023/11/25
NDC:43598-704
PREZCOBIX
Manufacturer:Janssen Products LP
Route:ORAL
Strength:800 mg in 1 1
Approved: 2023/08/15
NDC:59676-575
PREZISTA
Manufacturer:Physicians Total Care, Inc.
Route:ORAL
Strength:600 mg in 1 1
Approved: 2012/10/22
NDC:54868-6369

Singapore Approved Products

PREZISTA™ TABLET 400MG
Manufacturer:JANSSEN-CILAG SpA, JANSSEN-ORTHO LLC
Form:TABLET, FILM COATED
Strength:400mg
Online:Yes
Approved: 2010/08/26
Approval:SIN13855P
PREZISTA™ TABLET 75MG
Manufacturer:JANSSEN-CILAG SpA, JANSSEN-ORTHO LLC
Form:TABLET, FILM COATED
Strength:75mg
Online:Yes
Approved: 2010/08/26
Approval:SIN13853P
PREZISTA™ TABLET 150MG
Manufacturer:JANSSEN-CILAG SpA, JANSSEN-ORTHO LLC
Form:TABLET, FILM COATED
Strength:150mg
Online:Yes
Approved: 2010/08/26
Approval:SIN13854P
PREZISTA™ TABLET 800MG
Manufacturer:JANSSEN-ORTHO LLC, JANSSEN-CILAG SpA
Form:TABLET, FILM COATED
Strength:800 mg
Online:Yes
Approved: 2014/08/28
Approval:SIN14595P
PREZISTA™ TABLET 600MG
Manufacturer:JANSSEN-ORTHO LLC
Form:TABLET, FILM COATED
Strength:600mg
Online:Yes
Approved: 2010/08/26
Approval:SIN13856P

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