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EPIVIR-HBV Drug Profile

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

This drug has ninety-two patent family members in forty-eight countries.

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

Summary for Tradename: EPIVIR-HBV

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list2

Clinical Trials for: EPIVIR-HBV

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998RXYes5,905,082*PED<disabled>Y<disabled>
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998RXYes6,004,968*PED<disabled>Y<disabled>
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Expired Patents for Tradename: EPIVIR-HBV

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998RE39155*PED<disabled>
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 19985,047,407*PED<disabled>
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 19985,047,407*PED<disabled>
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Paragraph IV activity for: EPIVIR-HBV

Drugname Dosage Strength RLD Submissiondate
lamivudineTablets100 mgEpivir-HBV10/31/2007

International Patent Family for Tradename: EPIVIR-HBV

Country Document Number Estimated Expiration
Australia1736192<disabled in preview>
Estonia03996<disabled in preview>
Slovakia125793<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: EPIVIR-HBV

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0020Belgium<disabled>PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
80018Netherlands<disabled>PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
C/GB98/019United Kingdom<disabled>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
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