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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:YUNG SHIN PHARM. IND. CO., LTD.
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2021/11/19
NDC:63126-101
Entecavir
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2019/12/24
NDC:31722-834
Entecavir
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2019/12/24
NDC:31722-833
Entecavir
Manufacturer:Florida Pharmaceutical Products, LLC
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2021/01/26
NDC:71921-194
ENTECAVIR
Manufacturer:Solco Healthcare LLC
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2022/01/18
NDC:43547-436

Singapore Approved Products

BARACLUDE TABLET 1mg
Manufacturer:AstraZeneca Pharmaceuticals LP, CATALENT ANAGNI S.R.L. (Primary and secondary packaging), Patheon INC.
Form:TABLET, FILM COATED
Strength:1 mg
Online:Yes
Approved: 2006/01/16
Approval:SIN13167P
BEATECAVIR FILM COATED TABLET 1MG
Manufacturer:Remedica Ltd
Form:TABLET, FILM COATED
Strength:1mg
Online:Yes
Approved: 2022/10/05
Approval:SIN16619P
ENTECAVIR SANDOZ FILM-COATED TABLET 1MG
Manufacturer:Lek Pharmaceuticals d.d. (Ljubljana)
Form:TABLET, FILM COATED
Strength:1mg
Online:Yes
Approved: 2018/09/24
Approval:SIN15547P

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