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:EPIC PHARMA, LLC
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2020/06/02
NDC:42806-658
Entecavir
Manufacturer:Breckenridge Pharmaceutical, Inc.
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2020/02/29
NDC:51991-895
ENTECAVIR
Manufacturer:NorthStar RxLLC
Route:ORAL
Strength:1 mg in 1 1
Approved: 2022/11/24
NDC:16714-718
Entecavir
Manufacturer:Amneal Pharmaceuticals LLC
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2023/12/19
NDC:65162-446
Entecavir
Manufacturer:Zydus Pharmaceuticals USA Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2023/10/05
NDC:68382-921

Singapore Approved Products

ENTEVIR FILM-COATED TABLET 1MG
Manufacturer:PHARMATHEN INTERNATIONAL S.A., PHARMATHEN S.A. (Primary and Secondary packager)
Form:TABLET, FILM COATED
Strength:1.00mg
Online:Yes
Approved: 2020/10/28
Approval:SIN16034P
BEATECAVIR FILM COATED TABLET 0.5MG
Manufacturer:Remedica Ltd
Form:TABLET, FILM COATED
Strength:0.5mg
Online:Yes
Approved: 2022/10/05
Approval:SIN16620P
ENTECAVIR SANDOZ FILM-COATED TABLET 0.5MG
Manufacturer:Lek Pharmaceuticals d.d. (Ljubljana)
Form:TABLET, FILM COATED
Strength:0.5mg
Online:Yes
Approved: 2018/09/24
Approval:SIN15548P
ALMACAVIR (ENTECAVIR) FILM COATED TABLETS 0.5MG
Manufacturer:GENUONE Sciences Inc.
Form:TABLET, FILM COATED
Strength:0.5mg
Online:Yes
Approved: 2022/09/23
Approval:SIN16612P
BARACLUDE TABLET 0.5mg
Manufacturer:AstraZeneca Pharmaceuticals LP, CATALENT ANAGNI S.R.L. (Primary and secondary packaging), Patheon INC.
Form:TABLET, FILM COATED
Strength:0.5 mg
Online:Yes
Approved: 2006/01/16
Approval:SIN13165P

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