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Serving leading biopharmaceutical companies globally:

Deloitte
Fuji
AstraZeneca
Cantor Fitzgerald
Medtronic
Cerilliant
Boehringer Ingelheim
US Department of Justice
Merck
Citi

Generated: February 19, 2018

DrugPatentWatch Database Preview

EPIVIR-HBV Drug 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. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty-six patent family members in forty-three countries.

The generic ingredient in EPIVIR-HBV is lamivudine. There are twenty-eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the lamivudine profile page.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for EPIVIR-HBV
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 100 mg ➤ Subscribe 10/31/2007

International Patents for EPIVIR-HBV

Supplementary Protection Certificates for EPIVIR-HBV

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/019 United Kingdom ➤ Sign Up 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
C/GB96/043 United Kingdom ➤ Sign Up 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
C0020 Belgium ➤ Sign Up PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
C0022 France ➤ Sign Up PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
80018 Netherlands ➤ Sign Up PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Colorcon
Covington
Citi
Teva
AstraZeneca
Baxter
Express Scripts
McKesson

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 verifification 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.

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