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Serving leading biopharmaceutical companies globally:

McKinsey
Fuji
Express Scripts
Chinese Patent Office
Teva
Cerilliant
Julphar
AstraZeneca
Daiichi Sankyo
US Department of Justice

Generated: January 20, 2018

DrugPatentWatch Database Preview

Epivir-HBV Drug Profile

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Which patents cover Epivir-hbv, and when can generic versions of Epivir-hbv launch?

Epivir-hbv is a drug marketed by Glaxosmithkline and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-seven patent family members in forty-eight 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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine SOLUTION;ORAL 021004-001 Dec 8, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Subscribe ➤ Subscribe
Glaxosmithkline EPIVIR-HBV lamivudine TABLET;ORAL 021003-001 Dec 8, 1998 ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe 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
80018 Netherlands ➤ Subscribe PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
C0022 France ➤ Subscribe PRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
C0020 Belgium ➤ Subscribe PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
C/GB96/043 United Kingdom ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Covington
Dow
Cipla
Federal Trade Commission
Citi
Chinese Patent Office
Novartis
McKinsey

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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