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Synopsis

Chemistry

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Also known as:
Molecular Formula
C12H15N5O3
Molecular Weight
277.28  g/mol
InChI Key
QDGZDCVAUDNJFG-FXQIFTODSA-N

Entecavir
1 2D Structure

Entecavir

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-amino-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylidenecyclopentyl]-3H-purin-6-one
2.1.2 InChI
InChI=1S/C12H15N5O3/c1-5-6(3-18)8(19)2-7(5)17-4-14-9-10(17)15-12(13)16-11(9)20/h4,6-8,18-19H,1-3H2,(H3,13,15,16,20)/t6-,7-,8-/m0/s1
2.1.3 InChI Key
QDGZDCVAUDNJFG-FXQIFTODSA-N
2.1.4 Canonical SMILES
C=C1C(CC(C1CO)O)N2C=NC3=C2NC(=NC3=O)N
2.1.5 Isomeric SMILES
C=C1[C@H](C[C@@H]([C@H]1CO)O)N2C=NC3=C2NC(=NC3=O)N
2.2 Create Date
2005-08-01
3 Chemical and Physical Properties
Molecular Weight 277.28 g/mol
Molecular Formula C12H15N5O3
XLogP3-0.8
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count4
Rotatable Bond Count2
Exact Mass277.11748936 g/mol
Monoisotopic Mass277.11748936 g/mol
Topological Polar Surface Area126 A^2
Heavy Atom Count20
Formal Charge0
Complexity480
Isotope Atom Count0
Defined Atom Stereocenter Count3
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameBaraclude
PubMed HealthEntecavir (By mouth)
Drug ClassesAntiviral
Drug LabelBARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,...
Active IngredientEntecavir
Dosage FormTablet; Solution
RouteOral
Strength0.5mg; 0.05mg/ml; 1mg
Market StatusPrescription
CompanyBristol Myers Squibb

2 of 4  
Drug NameEntecavir
PubMed HealthEntecavir (By mouth)
Drug ClassesAntiviral
Drug LabelBARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,...
Active IngredientEntecavir
Dosage FormTablet
RouteOral
Strength0.5mg; 1mg
Market StatusPrescription
CompanyTeva Pharms Usa

3 of 4  
Drug NameBaraclude
PubMed HealthEntecavir (By mouth)
Drug ClassesAntiviral
Drug LabelBARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,...
Active IngredientEntecavir
Dosage FormTablet; Solution
RouteOral
Strength0.5mg; 0.05mg/ml; 1mg
Market StatusPrescription
CompanyBristol Myers Squibb

4 of 4  
Drug NameEntecavir
PubMed HealthEntecavir (By mouth)
Drug ClassesAntiviral
Drug LabelBARACLUDE is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one,...
Active IngredientEntecavir
Dosage FormTablet
RouteOral
Strength0.5mg; 1mg
Market StatusPrescription
CompanyTeva Pharms Usa

USDMF

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01

Medlab Asia & Asia Health
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02

Medlab Asia & Asia Health
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02

Medlab Asia & Asia Health
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GDUFA

DMF Review : Complete

Rev. Date : 2013-10-10

Pay. Date : 2013-08-27

DMF Number : 27401

Submission : 2013-08-31

Status : Active

Type : II

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03

Medlab Asia & Asia Health
Not Confirmed

03

Medlab Asia & Asia Health
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-05-12

Pay. Date : 2013-05-21

DMF Number : 24601

Submission : 2011-01-28

Status : Active

Type : II

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04

Cipla Ltd

India

USDMF

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04

Cipla Ltd

India
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Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-02-07

Pay. Date : 2014-01-29

DMF Number : 23663

Submission : 2010-05-21

Status : Active

Type : II

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05

Hetero Drugs Ltd

India

USDMF

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05

Medlab Asia & Asia Health
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GDUFA

DMF Review : Complete

Rev. Date : 2013-10-01

Pay. Date : 2013-03-18

DMF Number : 26307

Submission : 2012-08-14

Status : Active

Type : II

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06

Kyongbo Pharmaceutical Co Ltd

South Korea

USDMF

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Medlab Asia & Asia Health
Not Confirmed

06

Medlab Asia & Asia Health
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27066

Submission : 2013-04-05

Status : Inactive

Type : II

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07

Lek Pharmaceuticals Dd

Slovenia

USDMF

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Medlab Asia & Asia Health
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07

Medlab Asia & Asia Health
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GDUFA

DMF Review : Complete

Rev. Date : 2014-05-23

Pay. Date : 2013-11-21

DMF Number : 27719

Submission : 2013-12-17

Status : Active

Type : II

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Scinopharm Taiwan Ltd

Taiwan

USDMF

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Medlab Asia & Asia Health
Not Confirmed

08

Medlab Asia & Asia Health
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GDUFA

DMF Review : Complete

Rev. Date : 2014-02-28

Pay. Date : 2013-07-02

DMF Number : 25549

Submission : 2011-11-30

Status : Active

Type : II

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Medlab Asia & Asia Health
Not Confirmed

09

Medlab Asia & Asia Health
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27444

Submission : 2013-11-20

Status : Inactive

Type : II

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10

Medlab Asia & Asia Health
Not Confirmed

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Medlab Asia & Asia Health
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2014-08-13

Pay. Date : 2014-03-12

DMF Number : 27600

Submission : 2014-02-26

Status : Active

Type : II

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CEP/COS

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01

Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Certificate Number : CEP 2021-083 - Rev 01

Status : Valid

Issue Date : 2024-10-17

Type : Chemical

Substance Number : 2815

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02

Medlab Asia & Asia Health
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03

Medlab Asia & Asia Health
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04

Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Certificate Number : R1-CEP 2016-051 - Rev 00

Status : Valid

Issue Date : 2023-01-23

Type : Chemical

Substance Number : 2815

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05

Medlab Asia & Asia Health
Not Confirmed
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Medlab Asia & Asia Health
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Certificate Number : R0-CEP 2018-093 - Rev 00

Status : Valid

Issue Date : 2020-04-09

Type : Chemical

Substance Number : 2815

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06

Medlab Asia & Asia Health
Not Confirmed
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Medlab Asia & Asia Health
Not Confirmed

Certificate Number : CEP 2017-271 - Rev 04

Status : Valid

Issue Date : 2024-06-10

Type : Chemical

Substance Number : 2815

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Medlab Asia & Asia Health
Not Confirmed
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08

Medlab Asia & Asia Health
Not Confirmed
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Medlab Asia & Asia Health
Not Confirmed

Certificate Number : CEP 2018-006 - Rev 01

Status : Valid

Issue Date : 2024-07-09

Type : Chemical

Substance Number : 2815

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09

Medlab Asia & Asia Health
Not Confirmed
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API Reference Price

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CO.KG","supplierCountry":"CHINA","foreign_port":"GUANGZHOU","customer":"COHANCE LIFESCIENCES","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"178000","totalValueFC":"36012.3","currency":"USD","unitRateINR":"15103300","date":"22-Aug-2024","totalValueINR":"3020660","totalValueInUsd":"36012.3","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"5192722","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"GUANGZHOU","supplierAddress":"POSTFACH 305840-20318 HAMBURGSDNFSDNF DE","customerAddress":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE)"}]
15-Jan-2021
11-Oct-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
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Drugs in Development

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Details:

Proceeds will support clinical development of DST1308, using a silica-based drug delivery platform, for Chronic Hepatitis B.


Lead Product(s): Entecavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: DST1308

Study Phase: UndisclosedProduct Type: Small molecule

Sponsor: DRW Venture Capital LLC

Deal Size: $10.8 million Upfront Cash: Undisclosed

Deal Type: Financing January 16, 2024

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01

DelSiTech

Finland
arrow
Medlab Asia & Asia Health
Not Confirmed

DelSiTech

Finland
arrow
Medlab Asia & Asia Health
Not Confirmed

Details : Proceeds will support clinical development of DST1308, using a silica-based drug delivery platform, for Chronic Hepatitis B.

Brand Name : DST1308

Molecule Type : Small molecule

Upfront Cash : Undisclosed

January 16, 2024

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Details:

AB-729 is a subcutaneously-delivered RNAi therapeutic specifically designed to reduce all HBV viral antigens, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to virus.


Lead Product(s): AB-729,Vebicorvir,Entecavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: AB-729

Study Phase: Phase IIProduct Type: Large molecule

Sponsor: Assembly Biosciences

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 24, 2022

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02

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : AB-729 is a subcutaneously-delivered RNAi therapeutic specifically designed to reduce all HBV viral antigens, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to virus.

Brand Name : AB-729

Molecule Type : Large molecule

Upfront Cash : Not Applicable

October 24, 2022

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Details:

AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus.


Lead Product(s): AB-729,Vebicorvir,Entecavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: AB-729

Study Phase: Phase IIProduct Type: Large molecule

Sponsor: Assembly Biosciences

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 20, 2022

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03

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : AB-729 is an RNA interference (RNAi) therapeutic specifically designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is thought to be a key prerequisite to enable reawakening of a patient’s immune system to...

Brand Name : AB-729

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 20, 2022

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Details:

ABI-H0731 (Vebicorvir), is a first-generation core inhibitors has been shown to be well-tolerated and statistically superior in antiviral activity in hepatitis B virus DNA suppression.


Lead Product(s): Vebicorvir,AB-729,Entecavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 04, 2022

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04

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : ABI-H0731 (Vebicorvir), is a first-generation core inhibitors has been shown to be well-tolerated and statistically superior in antiviral activity in hepatitis B virus DNA suppression.

Brand Name : ABI-H0731

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 04, 2022

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Details:

ABI-H0731, a first-generation hepatitis B virus (HBV) core protein inhibitor, has demonstrated effective antiviral activity in chronic hepatitis B (CHB) patients also exhibited selective inhibition of HBV DNA replication.


Lead Product(s): Vebicorvir,Entecavir,Pegylated-interferon Alpha

Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 01, 2021

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05

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : ABI-H0731, a first-generation hepatitis B virus (HBV) core protein inhibitor, has demonstrated effective antiviral activity in chronic hepatitis B (CHB) patients also exhibited selective inhibition of HBV DNA replication.

Brand Name : ABI-H0731

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 01, 2021

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Details:

The Phase 2 clinical study for ABI-H2158 is a multi-center, randomized, placebo-controlled trial in treatment-naïve patients with HBeAg positive or HBeAg negative chronic hepatitis B infection without cirrhosis.


Lead Product(s): ABI-H2158,Entecavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H2158

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 01, 2021

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06

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : The Phase 2 clinical study for ABI-H2158 is a multi-center, randomized, placebo-controlled trial in treatment-naïve patients with HBeAg positive or HBeAg negative chronic hepatitis B infection without cirrhosis.

Brand Name : ABI-H2158

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 01, 2021

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Details:

Trial will evaluate Assembly’s core inhibitor candidate, vebicorvir, with Arbutus’ RNAi therapeutic candidate, AB-729, and standard-of-care NrtI therapy.


Lead Product(s): Vebicorvir,AB-729,Entecavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: BeiGene

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 26, 2021

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07

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Trial will evaluate Assembly’s core inhibitor candidate, vebicorvir, with Arbutus’ RNAi therapeutic candidate, AB-729, and standard-of-care NrtI therapy.

Brand Name : ABI-H0731

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 26, 2021

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Details:

Assembly Biosciences is foregoing its plans to initiate Phase 3 registrational studies of vebicorvir (VBR, or ABI-H0731) as a chronic suppressive therapy (CST) to concentrate its research and development efforts on finite and curative HBV therapies.


Lead Product(s): Vebicorvir,GalNAc-RNAi,Entecavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 25, 2021

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08

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Assembly Biosciences is foregoing its plans to initiate Phase 3 registrational studies of vebicorvir (VBR, or ABI-H0731) as a chronic suppressive therapy (CST) to concentrate its research and development efforts on finite and curative HBV therapies.

Brand Name : ABI-H0731

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 25, 2021

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Details:

In Phase 2 clinical trials, first-generation core inhibitor vebicorvir administered with nucleos(t)ide analogue reverse transcriptase inhibitor therapy has been well-tolerated, has shown statistically superior antiviral activity in HBV DNA suppression to NrtI therapy alone.


Lead Product(s): Vebicorvir,Tenofovir Alafenamide,Entecavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 02, 2020

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09

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : In Phase 2 clinical trials, first-generation core inhibitor vebicorvir administered with nucleos(t)ide analogue reverse transcriptase inhibitor therapy has been well-tolerated, has shown statistically superior antiviral activity in HBV DNA suppression to...

Brand Name : ABI-H0731

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 02, 2020

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Details:

Assembly’s novel core inhibitor vebicorvir in combination with standard-of-care NrtI continues to demonstrate a favorable safety and tolerability profile, with no observed treatment-emergent resistance in patients with HBeAg negative chronic HBV infection.


Lead Product(s): Vebicorvir,Entecavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: ABI-H0731

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 28, 2020

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10

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Assembly’s novel core inhibitor vebicorvir in combination with standard-of-care NrtI continues to demonstrate a favorable safety and tolerability profile, with no observed treatment-emergent resistance in patients with HBeAg negative chronic HBV infect...

Brand Name : ABI-H0731

Molecule Type : Small molecule

Upfront Cash : Not Applicable

August 28, 2020

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FDA Orange Book

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01

BRECKENRIDGE

U.S.A
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Medlab Asia & Asia Health
Not Confirmed

ENTECAVIR

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2018-03-15

Application Number : 208721

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

02

BRECKENRIDGE

U.S.A
arrow
Medlab Asia & Asia Health
Not Confirmed

ENTECAVIR

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2018-03-15

Application Number : 208721

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

03

Medlab Asia & Asia Health
Not Confirmed
arrow
arrow
Medlab Asia & Asia Health
Not Confirmed

ENTECAVIR

Brand Name : BARACLUDE

Dosage Form : SOLUTION;ORAL

Dosage Strength : 0.05MG/ML

Approval Date : 2005-03-29

Application Number : 21798

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

CHARTWELL RX

U.S.A
Medlab Asia & Asia Health
Not Confirmed
arrow

CHARTWELL RX

U.S.A
arrow
Medlab Asia & Asia Health
Not Confirmed

ENTECAVIR

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2017-05-11

Application Number : 206672

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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05

CIPLA

India
Medlab Asia & Asia Health
Not Confirmed
arrow

CIPLA

India
arrow
Medlab Asia & Asia Health
Not Confirmed

ENTECAVIR

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2016-12-06

Application Number : 206872

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

RISING

U.S.A
Medlab Asia & Asia Health
Not Confirmed
arrow

RISING

U.S.A
arrow
Medlab Asia & Asia Health
Not Confirmed

ENTECAVIR

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2019-03-26

Application Number : 206226

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

SUNSHINE

China
Medlab Asia & Asia Health
Not Confirmed
arrow

SUNSHINE

China
arrow
Medlab Asia & Asia Health
Not Confirmed

ENTECAVIR

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2020-05-20

Application Number : 211978

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

Medlab Asia & Asia Health
Not Confirmed
arrow
arrow
Medlab Asia & Asia Health
Not Confirmed

ENTECAVIR

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2014-08-26

Application Number : 202122

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

ZYDUS PHARMS

U.S.A
Medlab Asia & Asia Health
Not Confirmed
arrow

ZYDUS PHARMS

U.S.A
arrow
Medlab Asia & Asia Health
Not Confirmed

ENTECAVIR

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG

Approval Date : 2017-06-23

Application Number : 206745

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

ZYDUS PHARMS

U.S.A
Medlab Asia & Asia Health
Not Confirmed
arrow

ZYDUS PHARMS

U.S.A
arrow
Medlab Asia & Asia Health
Not Confirmed

ENTECAVIR

Brand Name : ENTECAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG

Approval Date : 2017-06-23

Application Number : 206745

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 0.5MG

USFDA APPLICATION NUMBER - 21797

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DOSAGE - TABLET;ORAL - 1MG

USFDA APPLICATION NUMBER - 21797

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DOSAGE - SOLUTION;ORAL - 0.05MG/ML

USFDA APPLICATION NUMBER - 21798

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