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Last Updated: November 11, 2024

EPIVIR-HBV Drug Patent Profile


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When do Epivir-hbv patents expire, and what generic alternatives are available?

Epivir-hbv is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in EPIVIR-HBV is lamivudine. There are twenty-nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the lamivudine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Epivir-hbv

A generic version of EPIVIR-HBV was approved as lamivudine by APOTEX on December 2nd, 2011.

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Drug patent expirations by year for EPIVIR-HBV
Drug Prices for EPIVIR-HBV

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Recent Clinical Trials for EPIVIR-HBV

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Roswell Park Cancer InstitutePhase 2
Bess Frost, PhDPhase 1/Phase 2
Owens Medical Research FoundationPhase 1/Phase 2

See all EPIVIR-HBV clinical trials

US Patents and Regulatory Information for EPIVIR-HBV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 DISCN Yes 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 EPIVIR-HBV

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ⤷  Sign Up ⤷  Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for EPIVIR-HBV

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Teva B.V.  Lamivudine Teva Pharma B.V. lamivudine EMEA/H/C/001111
Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.
Authorised yes no no 2009-12-10
Teva B.V. Lamivudine Teva lamivudine EMEA/H/C/001113
Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).
Authorised yes no no 2009-10-23
GlaxoSmithKline (Ireland) Limited Zeffix lamivudine EMEA/H/C/000242
Zeffix is indicated for the treatment of chronic hepatitis B in adults with:, , , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;, decompensated liver disease in combination with a second agent without cross-resistance to lamivudine., ,
Authorised no no no 1999-07-29
ViiV Healthcare BV Epivir lamivudine EMEA/H/C/000107
Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.,
Authorised no no no 1996-08-08
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for EPIVIR-HBV

See the table below for patents covering EPIVIR-HBV around the world.

Country Patent Number Title Estimated Expiration
Australia 4920190 ⤷  Sign Up
European Patent Office 0517145 Dérivés d'oxathiolane cristallisés (Crystalline oxathiolane derivatives) ⤷  Sign Up
Japan 2644357 ⤷  Sign Up
European Patent Office 0494119 ⤷  Sign Up
Australia 631786 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EPIVIR-HBV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0382526 19675032 Germany ⤷  Sign Up PRODUCT NAME: LAMIVUDINE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH GEEIGNETEN SALZES; NAT. REGISTRATION NO/DATE: EU/1/96/015/001-002 19960808 FIRST REGISTRATION: CH 53662 53663 19960228
2924034 LUC00114 Luxembourg ⤷  Sign Up PRODUCT NAME: DORAVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC LA LAMIVUDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI EN COMBINAISON AVEC DU TENOFOVIR OU UN DE SES ESTERS, EN PARTICULIER UN ESTER DE DISOPROXIL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SEL DE FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/18/1333 20181126
0382526 C960025 Netherlands ⤷  Sign Up PRODUCT NAME: LAMIVUDINUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/015/001 - EU/1/96/015/002 19960808
2924034 2019/021 Ireland ⤷  Sign Up PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333/001 EU/1/18/1333/002 20181122
2924034 1990024-0 Sweden ⤷  Sign Up PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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