MedPath

Entecavir

Generic Name
Entecavir
Brand Names
Baraclude, Entecavir Viatris (previously Entecavir Mylan), Entecavir Accord
Drug Type
Small Molecule
Chemical Formula
C12H15N5O3
CAS Number
142217-69-4
Unique Ingredient Identifier
NNU2O4609D

Overview

Entecavir is an oral antiviral drug used in the treatment of hepatitis B infection. It is marketed under the trade name Baraclude (BMS). Entecavir is a guanine analogue that inhibits all three steps in the viral replication process, and the manufacturer claims that it is more efficacious than previous agents used to treat hepatitis B (lamivudine and adefovir). It was approved by the U.S. Food and Drug Administration (FDA) in March 2005.

Background

Entecavir is an oral antiviral drug used in the treatment of hepatitis B infection. It is marketed under the trade name Baraclude (BMS). Entecavir is a guanine analogue that inhibits all three steps in the viral replication process, and the manufacturer claims that it is more efficacious than previous agents used to treat hepatitis B (lamivudine and adefovir). It was approved by the U.S. Food and Drug Administration (FDA) in March 2005.

Indication

For the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Associated Conditions

  • Chronic Hepatitis B Infection

FDA Approved Products

Entecavir
Manufacturer:AvKARE
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2024/01/09
NDC:42291-261
Entecavir
Manufacturer:Zydus Lifesciences Limited
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2022/08/26
NDC:70771-1019
Entecavir
Manufacturer:Aurobindo Pharma Limited
Route:ORAL
Strength:1 mg in 1 1
Approved: 2023/11/23
NDC:65862-842
Entecavir
Manufacturer:Aurobindo Pharma Limited
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2023/11/23
NDC:65862-841
Entecavir
Manufacturer:Breckenridge Pharmaceutical, Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2020/02/29
NDC:51991-896

Singapore Approved Products

ENTECAVIR-TEVA FC TABLETS 0.5MG
Manufacturer:Remedica Ltd.
Form:TABLET, FILM COATED
Strength:0.5mg
Online:Yes
Approved: 2021/01/31
Approval:SIN16092P
HEPURI F.C. TABLETS 0.5 MG
Manufacturer:Standard Chem. & Pharm. Co. Ltd., 2nd Plant
Form:TABLET, FILM COATED
Strength:0.5 mg
Online:Yes
Approved: 2021/01/28
Approval:SIN16090P
ENTECAVIR ALVOGEN FILM COATED TABLETS 1 MG
Manufacturer:Sanofi Ilac Sanayi ve Ticaret Anonim Sirketi, MEDIS INTERNATIONAL a.s., výrobní závod Bolatice (Primary and Secondary packager)
Form:TABLET, FILM COATED
Strength:1.00mg
Online:Yes
Approved: 2021/04/06
Approval:SIN16145P
TECAVIR FILM COATED TABLETS 0.5 MG
Manufacturer:Hetero Labs Limited
Form:TABLET, FILM COATED
Strength:0.500 mg
Online:Yes
Approved: 2023/05/23
Approval:SIN16792P
ENTECAVIR ALVOGEN FILM COATED TABLETS 0.5 MG
Manufacturer:Sanofi Ilac Sanayi ve Ticaret Anonim Sirketi, MEDIS INTERNATIONAL a.s., výrobní závod Bolatice (Primary and Secondary packager)
Form:TABLET, FILM COATED
Strength:0.5mg
Online:Yes
Approved: 2021/04/06
Approval:SIN16146P

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