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:Zydus Pharmaceuticals USA Inc.
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2023/10/05
NDC:68382-920
BARACLUDE
Manufacturer:E.R. Squibb & Sons, L.L.C.
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2018/12/20
NDC:0003-1611
BARACLUDE
Manufacturer:E.R. Squibb & Sons, L.L.C.
Route:ORAL
Strength:1.0 mg in 1 1
Approved: 2018/12/20
NDC:0003-1612
ENTECAVIR
Manufacturer:Cipla USA Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2022/12/23
NDC:69097-425
BARACLUDE
Manufacturer:E.R. Squibb & Sons, L.L.C.
Route:ORAL
Strength:0.05 mg in 1 mL
Approved: 2018/12/20
NDC:0003-1614

Singapore Approved Products

ENTECA FILM COATED TABLET 0.5MG
Manufacturer:SUN PHARMACEUTICAL INDUSTRIES LIMITED
Form:TABLET, FILM COATED
Strength:0.5mg
Online:Yes
Approved: 2022/09/12
Approval:SIN16601P
ENTECAVIR STELLA FILM-COATED TABLET 0.5MG
Manufacturer:STELLAPHARM J.V. CO., LTD. - BRANCH 1
Form:TABLET, FILM COATED
Strength:0.5mg
Online:Yes
Approved: 2022/06/23
Approval:SIN16519P
ENTECA FILM-COATED TABLET 1MG
Manufacturer:SUN PHARMACEUTICAL INDUSTRIES LIMITED
Form:TABLET, FILM COATED
Strength:1mg
Online:Yes
Approved: 2022/09/12
Approval:SIN16600P
ENTEVIR FILM-COATED TABLET 0.5MG
Manufacturer:PHARMATHEN INTERNATIONAL S.A., PHARMATHEN S.A. (Primary and Secondary packager)
Form:TABLET, FILM COATED
Strength:0.50mg
Online:Yes
Approved: 2020/10/28
Approval:SIN16035P
PMS-ENTECAVIR FILM COATED TABLET 0.5mg
Manufacturer:Pharmascience Inc
Form:TABLET, FILM COATED
Strength:0.50 mg
Online:Yes
Approved: 2021/02/02
Approval:SIN16094P

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