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EPIVIR Drug Profile
» See Plans and Pricing
Which patents cover Epivir, and when can generic versions of Epivir launch?
Epivir is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs.
The generic ingredient in EPIVIR 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
A generic version of EPIVIR was approved as lamivudine by AUROBINDO PHARMA LTD on November 17th, 2011.
Summary for EPIVIR
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 4 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 126 |
Clinical Trials: | 31 |
Patent Applications: | 3,569 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EPIVIR |
What excipients (inactive ingredients) are in EPIVIR? | EPIVIR excipients list |
DailyMed Link: | EPIVIR at DailyMed |


US Patents and Regulatory Information for EPIVIR
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | AA | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | Start Trial | Start Trial |
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | Start Trial | Start Trial |
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | Start Trial | Start Trial |
Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPIVIR
Country | Patent Number | Estimated Expiration |
---|---|---|
African Regional IP Organization (ARIPO) | 9200395 | Start Trial |
Guatemala | 199800052 | Start Trial |
African Intellectual Property Organization (OAPI) | 9913 | Start Trial |
European Patent Office | 1099700 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EPIVIR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0817637 | 05C0022 | France | Start Trial | PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217 |
2924034 | 2019/021 | Ireland | Start Trial | 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 |
0382526 | SZ 22/1996 | Austria | Start Trial | PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE |
2924034 | LUC00114 | Luxembourg | Start Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |