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:YUNG SHIN PHARM. IND. CO., LTD.
Route:ORAL
Strength:1 mg in 1 1
Approved: 2021/11/19
NDC:63126-102
ENTECAVIR
Manufacturer:Solco Healthcare LLC
Route:ORAL
Strength:1 mg in 1 1
Approved: 2022/01/18
NDC:43547-437
Entecavir
Manufacturer:American Health Packaging
Route:ORAL
Strength:0.5 mg in 1 1
Approved: 2023/09/26
NDC:60687-216
Entecavir
Manufacturer:EPIC PHARMA, LLC
Route:ORAL
Strength:1 mg in 1 1
Approved: 2020/06/02
NDC:42806-659
Entecavir
Manufacturer:Zydus Lifesciences Limited
Route:ORAL
Strength:1 mg in 1 1
Approved: 2022/08/26
NDC:70771-1020

Singapore Approved Products

BECAVIR F.C. TABLET 0.5 mg
Manufacturer:UBI Pharma Inc (Hsinchu Plant)
Form:TABLET, FILM COATED
Strength:0.5 mg
Online:Yes
Approved: 2020/06/15
Approval:SIN15955P
ENTECAVIR-TEVA FC TABLETS 1MG
Manufacturer:Remedica Ltd.
Form:TABLET, FILM COATED
Strength:1mg
Online:Yes
Approved: 2021/01/31
Approval:SIN16093P
HOVID-ENTECAVIR FILM COATED TABLET 1 MG
Manufacturer:RA CHEM PHARMA LIMITED
Form:TABLET, FILM COATED
Strength:1mg
Online:Yes
Approved: 2023/03/02
Approval:SIN16724P
HOVID-ENTECAVIR FILM COATED TABLET 0.5 MG
Manufacturer:RA CHEM PHARMA LIMITED
Form:TABLET, FILM COATED
Strength:0.5mg
Online:Yes
Approved: 2023/03/02
Approval:SIN16725P
TECAVIR FILM COATED TABLETS 1 MG
Manufacturer:Hetero Labs Limited
Form:TABLET, FILM COATED
Strength:1.000mg
Online:Yes
Approved: 2023/05/23
Approval:SIN16793P

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