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EPIVIR-HBV Drug Profile

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Which patents cover Epivir-hbv, and what substitute generic drugs are available?

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-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. Twenty-two 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 list3
Bulk Api Vendors: see list86
Clinical Trials: see list181
Patent Applications: see list2,022
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EPIVIR-HBV at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998RXYesYes5,905,082*PED► Subscribe ► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998RXYesYes6,004,968*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: EPIVIR-HBV

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 19985,047,407*PED► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 19985,047,407*PED► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998RE39155*PED► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 19987,119,202*PED► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 19985,532,246*PED► Subscribe
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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
Canada2286126► Subscribe
Iceland4268► Subscribe
Israel102073► Subscribe
Poland336038► Subscribe
Czech Republic9903403► Subscribe
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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
C/GB98/019United Kingdom► SubscribePRODUCT 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
80018Netherlands► SubscribePRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
C0020Belgium► SubscribePRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
C/GB96/043United Kingdom► SubscribePRODUCT 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
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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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