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Last Updated: May 26, 2022

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. Seventeen 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 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for EPIVIR-HBV

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

Country Patent Number Title Estimated Expiration
Czech Republic 284513 (-)cis-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan 5-yl)-(1H)-pyrimidin-2-on v krystalické formě ((-)CIS-4-AMINO-1-(2-HYDROXYMETHYL-1,3-OXATHIOLAN-5-YL)- (1H)PYRIMIDIN-2-ONE IN CRYSTALLINE FORM, PROCESS OF ITS PREPARATION AND PHARMACEUTICAL COMPOSITION CONTAINING THEREOF) See Plans and Pricing
Mexico 9202619 DERIVADOS DE OXA TIOLANO CRISTALINO, METODO PARA SU PREPARACION Y FORMULACION FARMACEUTICA QUE LOS CONTIENE. See Plans and Pricing
China 1033640 See Plans and Pricing
Germany 69026971 See Plans and Pricing
Austria 138065 See Plans and Pricing
African Intellectual Property Organization (OAPI) 9913 See Plans and Pricing
Cyprus 2036 Substitued-1,3-oxathiolanes with antiviral properties See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EPIVIR-HBV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513917 C980018 Netherlands See Plans and Pricing PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
2924034 CR 2019 00024 Denmark See Plans and Pricing PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
2924034 LUC00114 Luxembourg See Plans and Pricing 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
0513917 SPC/GB98/019 United Kingdom See Plans and Pricing 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
2924034 CA 2019 00024 Denmark See Plans and Pricing PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126
2924034 300981 Netherlands See Plans and Pricing PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126
0382526 SPC/GB96/043 United Kingdom See Plans and Pricing PRODUCT NAME: LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: CH 53662 19960228; CH 53663 19960228; UK EU/1/96/015/001 19960808; UK EU/1/96/015/002 19960808
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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