Epivir-HBV Drug Patent Profile
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Which patents cover Epivir-hbv, 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. Sixteen 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: | 146 |
| Clinical Trials: | 46 |
| Patent Applications: | 2,772 |
| 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 |
Pharmacology for Epivir-HBV
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 | ⤷ 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-HBV
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline | EPIVIR-HBV | lamivudine | SOLUTION;ORAL | 021004-001 | Dec 8, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for Epivir-HBV
| 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-HBV
See the table below for patents covering Epivir-HBV around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 932442 | ⤷ Try a Trial | |
| Hong Kong | 5996 | 2-substituted-4-substituted-1,3-dioxolanes synthesis and use thereof | ⤷ Try a Trial |
| Germany | 69201948 | ⤷ Try a Trial | |
| Germany | 69232387 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Epivir-HBV
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 0382526 | 96C0035 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228 |
| 0513917 | C980018 | Netherlands | ⤷ Try a 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 | ⤷ 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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