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. Sixteen 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: | 146 |
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 |
Bess Frost, PhD | Phase 1/Phase 2 |
Owens Medical Research Foundation | 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 | |||
Glaxosmithkline | EPIVIR-HBV | lamivudine | TABLET;ORAL | 021003-001 | Dec 8, 1998 | 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 | TABLET;ORAL | 020564-003 | Jun 24, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | EPIVIR | lamivudine | SOLUTION;ORAL | 020596-001 | Nov 17, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Viiv Hlthcare | EPIVIR | lamivudine | TABLET;ORAL | 020564-003 | Jun 24, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
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 |
>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 |
---|---|---|---|
Iceland | 1867 | ⤷ Try a Trial | |
Norway | 920018 | ⤷ Try a Trial | |
Uruguay | 24930 | COMPOSICIONES FARMACEUTICAS QUE CONTIENEN (2R, CIS)-4-AMINO-1-(2-HIDROXIMETIL-1,3 -OXATIOLAN-5-IL)-(1H)-PIRIMIDIN-2-ONA (LAMIVUDINA) | ⤷ Try a Trial |
Romania | 112616 | DERIVAT DE 1,3-OXATIOLAN-NUCLEOZIDA, PROCEDEU PENTRU PREPARAREA ACESTUIA, COMPOZITIE FARMACEUTICA SI METODA DE TRATAMENT (1,3-OXOTIOLAN-NUCLEOZIDE DERIVATIVE, METHOD FOR PREPARATION, PHARMACEUTICAL COMPOSITION AND METHOD OF TREATMENT) | ⤷ Try a Trial |
South Africa | 8902645 | ⤷ Try a Trial | |
Japan | H05501117 | ⤷ Try a Trial | |
Denmark | 0517145 | ⤷ 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 |
---|---|---|---|---|
0382526 | SZ 22/1996 | Austria | ⤷ Try a Trial | PRODUCT NAME: LAMIVUDIN UND DESSEN PHARMAZEUTISCH ANNEHMBARE SALZE |
2924034 | 2019C/005 | Belgium | ⤷ 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 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 |
0513917 | SPC/GB98/019 | United Kingdom | ⤷ Try a 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 |
2924034 | CR 2019 00024 | Denmark | ⤷ Try a Trial | 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 | 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 |
0382526 | SPC/GB96/043 | United Kingdom | ⤷ Try a Trial | 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 |
2924034 | 1990024-0 | Sweden | ⤷ Try a Trial | PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |