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Last Updated: November 4, 2024

ENTECAVIR Drug Patent Profile


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Which patents cover Entecavir, and what generic alternatives are available?

Entecavir is a drug marketed by 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 seventeen NDAs.

The generic ingredient in ENTECAVIR is entecavir. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Entecavir

A generic version of ENTECAVIR was approved as entecavir by HETERO LABS LTD V on August 21st, 2015.

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Drug patent expirations by year 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
Yung Shin Pharm ENTECAVIR entecavir TABLET;ORAL 208195-002 Nov 10, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa ENTECAVIR entecavir TABLET;ORAL 202122-002 Aug 26, 2014 DISCN 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

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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