EPIVIR Drug Patent Profile
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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. Seventeen 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 APOTEX on December 2nd, 2011.
Summary for EPIVIR
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 145 |
Clinical Trials: | 46 |
Patent Applications: | 2,772 |
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 |


Recent Clinical Trials for EPIVIR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Roswell Park Cancer Institute | Phase 2 |
Owens Medical Research Foundation | Phase 1/Phase 2 |
Bess Frost, PhD | Phase 1/Phase 2 |
Pharmacology for EPIVIR
Anatomical Therapeutic Chemical (ATC) Classes for EPIVIR
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-001 | Nov 17, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for EPIVIR
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
See the table below for patents covering EPIVIR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Austria | 254125 | ⤷ Try a Trial | |
Japan | H06211848 | CRYSTALLINE OXATHIOLANE DERIVATIVE | ⤷ Try a Trial |
Finland | 111722 | ⤷ Try a Trial | |
Japan | H037282 | ANTIVIRAL SUBSTITUTED 1,3-OXATHIOLANE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EPIVIR
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 |
2924034 | SPC/GB19/024 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL; REGISTERED: UK EU/1/18/1333/001-002 20181122; UK PLGB 5305/0015 20181122 |
2924034 | CA 2019 00024 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE, LAMIVUDINE AND DISOPROXIL; REG. NO/DATE: EU/1/18/1333 20181126 |
2924034 | 300981 | Netherlands | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |