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EPIVIR-HBV Drug Profile
» See Plans and Pricing
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. Nineteen 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 AUROBINDO PHARMA LTD on November 17th, 2011.
Summary for EPIVIR-HBV
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 126 |
| Clinical Trials: | 31 |
| Patent Applications: | 3,656 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EPIVIR-HBV |
| DailyMed Link: | EPIVIR-HBV at DailyMed |
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 | Start Trial | Start Trial | Start Trial | ||||
| Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | Start Trial | Start Trial |
| Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | Start Trial | Start Trial |
| Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | Start Trial | Start Trial |
| Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | Start Trial | Start Trial |
| Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPIVIR-HBV
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 932442 | Start Trial |
| Hong Kong | 5996 | Start Trial |
| Germany | 69201948 | Start Trial |
| Germany | 69232387 | Start Trial |
| European Patent Office | 0674634 | Start Trial |
| Portugal | 969815 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EPIVIR-HBV
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2924034 | 2019C/005 | Belgium | Start Trial | PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAARZOUT, 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; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126 |
| 0382526 | 96C0035 | Belgium | Start Trial | PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228 |
| 0513917 | C980018 | Netherlands | Start Trial | 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 | 300981 | Netherlands | Start Trial | 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 |
| 0513917 | SPC/GB98/019 | United Kingdom | Start 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 | Start Trial | PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
