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.
Summary for EPIVIR-HBV
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 132 |
Clinical Trials: | 46 |
Patent Applications: | 70 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EPIVIR-HBV |
DailyMed Link: | EPIVIR-HBV at DailyMed |


Recent Clinical Trials for EPIVIR-HBV
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Roswell Park Cancer Institute | Phase 2 |
Bess Frost, PhD | Phase 1/Phase 2 |
Owens Medical Research Foundation | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for EPIVIR-HBV
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 |