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Serving leading biopharmaceutical companies globally:

Argus Health
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Chubb
Daiichi Sankyo
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Cerilliant
Harvard Business School
Federal Trade Commission
Accenture
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Generated: November 19, 2017

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 and five supplementary protection certificates in four 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.
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
TABLET;ORAL021003-001Dec 8, 1998ABRXYesYes► Subscribe► Subscribe ► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998RXYesYes► Subscribe► 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
SOLUTION;ORAL021004-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
Austria295150► Subscribe
African Regional IP Organization (ARIPO)1141► Subscribe
Panama8449301► Subscribe
Australia656379► Subscribe
Slovakia283417► Subscribe
Yugoslavia47799► Subscribe
Bulgaria103818► Subscribe
European Patent Office0969815► Subscribe
Australia7208498► Subscribe
Iceland5184► 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
C0020Belgium► SubscribePRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 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
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
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
C0022France► SubscribePRODUCT NAME: ABACAVIR SULFATE; LAMIVUDINE; REGISTRATION NO/DATE: EU/1/04/298/001 20041217
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Serving leading biopharmaceutical companies globally:

Healthtrust
Novartis
Cantor Fitzgerald
US Army
Farmers Insurance
Merck
Cerilliant
Mallinckrodt
Citi
Federal Trade Commission

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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