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Last Updated: March 28, 2024

EPIVIR-HBV Drug Patent Profile


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Which patents cover Epivir-hbv, and when can generic versions of Epivir-hbv launch?

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
Owens Medical Research FoundationPhase 1/Phase 2
Bess Frost, PhDPhase 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 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 SOLUTION;ORAL 021004-001 Dec 8, 1998 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ⤷  Try a Trial ⤷  Try a Trial
>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
Netherlands 960025 ⤷  Try a Trial
Germany 69233014 ⤷  Try a Trial
Japan 3264937 ⤷  Try a Trial
Japan 3085675 ⤷  Try a Trial
Honduras 1998000045 COMPOSICIONES FARMACEUTICAS ⤷  Try a Trial
Peru 61699 COMPOSICION FARMACEUTICA DE LAMIVUDINA ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EPIVIR-HBV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513917 98C0020 Belgium ⤷  Try a Trial PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
0382526 C960025 Netherlands ⤷  Try a Trial 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
0382526 96C0035 Belgium ⤷  Try a Trial PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228
0513917 SPC/GB98/019 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318
0382526 SZ 22/1996 Austria ⤷  Try a Trial PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE
0817637 05C0022 France ⤷  Try a Trial PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.