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Doravirine

Generic Name
Doravirine
Brand Names
Delstrigo, Pifeltro
Drug Type
Small Molecule
Chemical Formula
C17H11ClF3N5O3
CAS Number
1338225-97-0
Unique Ingredient Identifier
913P6LK81M

Overview

Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) intended to be administered in combination with other antiretroviral medicines. Doravirine is available by itself or as a combination product of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg). Doravirine is formally indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, further expanding the possibility and choice of therapeutic treatments available for the management of HIV-1 infection.

Background

Doravirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) intended to be administered in combination with other antiretroviral medicines. Doravirine is available by itself or as a combination product of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg). Doravirine is formally indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, further expanding the possibility and choice of therapeutic treatments available for the management of HIV-1 infection.

Indication

Doravirine is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment history. It is also indicated to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

Associated Conditions

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

FDA Approved Products

PIFELTRO
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:100 mg in 1 1
Approved: 2022/06/13
NDC:50090-6237
PIFELTRO
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:100 mg in 1 1
Approved: 2023/11/14
NDC:50090-6268
DELSTRIGO
Manufacturer:Merck Sharp & Dohme LLC
Route:ORAL
Strength:100 mg in 1 1
Approved: 2023/11/14
NDC:0006-5007
PIFELTRO
Manufacturer:Merck Sharp & Dohme LLC
Route:ORAL
Strength:100 mg in 1 1
Approved: 2023/11/14
NDC:0006-3069

Singapore Approved Products

PIFELTRO FILM-COATED TABLET 100MG
Manufacturer:Hovione FarmaCiencia S.A. (DP intermediate), MSD International GmbH T/A MSD Ireland (Ballydine), Merck Sharp & Dohme B.V. (Primary and Secondary packager)
Form:TABLET, FILM COATED
Strength:100.0mg
Online:Yes
Approved: 2019/12/12
Approval:SIN15869P
DELSTRIGO FILM COATED TABLET 100MG/300MG/300MG
Manufacturer:PT Organon Pharma Indonesia Tbk (Primary and secondary packager), MSD International GmbH T/A MSD Ireland (Ballydine), Hovione FarmaCiencia S.A. (DP Intermediate)
Form:TABLET, FILM COATED
Strength:100mg
Online:Yes
Approved: 2020/03/13
Approval:SIN15909P

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