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EPIVIR-HBV Drug Profile
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» See Plans and PricingWhen 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. Twenty suppliers are listed for this compound. Additional details are available on the lamivudine profile page.
US ANDA 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: | 121 |
| Clinical Trials: | 29 |
| Patent Applications: | 2,382 |
| 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 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EPIVIR-HBV
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| African Regional IP Organization (ARIPO) | 300 | Start Trial |
| Eurasian Patent Organization | 199900757 | Start Trial |
| Canada | 2070230 | 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 | 19C1025 | France | Start Trial | PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE LAMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 20181126 |
| 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 |
| 0817637 | 05C0022 | France | Start Trial | PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
