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Last Updated: November 4, 2024

Entecavir - Generic Drug Details


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What are the generic drug sources for entecavir and what is the scope of patent protection?

Entecavir is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Accord Hlthcare, Amneal Pharms, Aurobindo Pharma, Breckenridge, Brightgene, Chartwell Rx, Cipla, Hetero Labs Ltd V, Prinston Inc, Rising, Sunshine, Swiss Pharm, Teva Pharms Usa, Yaopharma Co Ltd, Yung Shin Pharm, and Zydus Pharms, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for entecavir. Sixteen suppliers are listed for this compound.

Summary for entecavir
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Recent Clinical Trials for entecavir

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SponsorPhase
Shanghai HEP Pharmaceutical Co., Ltd.Phase 2
E-DA HospitalN/A
Shanghai Zhimeng Biopharma, Inc.Phase 2

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Paragraph IV (Patent) Challenges for ENTECAVIR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BARACLUDE Tablets entecavir 0.5 mg and 1 mg 021797 1 2010-06-14

US Patents and Regulatory Information for entecavir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms ENTECAVIR entecavir TABLET;ORAL 206745-002 Jun 23, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising ENTECAVIR entecavir TABLET;ORAL 206226-001 Mar 26, 2019 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Brightgene ENTECAVIR entecavir TABLET;ORAL 212126-002 Sep 25, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx ENTECAVIR entecavir TABLET;ORAL 206294-001 Nov 23, 2016 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal Pharms ENTECAVIR entecavir TABLET;ORAL 206652-002 Nov 12, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms ENTECAVIR entecavir TABLET;ORAL 206745-001 Jun 23, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for entecavir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-002 Mar 29, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb BARACLUDE entecavir TABLET;ORAL 021797-001 Mar 29, 2005 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb BARACLUDE entecavir SOLUTION;ORAL 021798-001 Mar 29, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for entecavir

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Mylan Pharmaceuticals Limited Entecavir Mylan entecavir EMEA/H/C/004377
Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.Entecavir Mylan is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to
Authorised yes no no 2017-09-18
Bristol-Myers Squibb Pharma EEIG Baraclude entecavir EMEA/H/C/000623
Baraclude is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis;decompensated liver disease.For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B.
Authorised no no no 2006-06-26
Accord Healthcare S.L.U. Entecavir Accord entecavir EMEA/H/C/004458
Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with:, , , compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis., decompensated liver disease., , , For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine-refractory hepatitis B., , Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to
Authorised yes no no 2017-09-25
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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