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Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Fish and Richardson
Medtronic
Accenture
Moodys
AstraZeneca
US Army
Teva
Julphar

Generated: October 23, 2017

DrugPatentWatch Database Preview

EPIVIR Drug Profile

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Which patents cover Epivir, and what generic Epivir alternatives are available?

Epivir is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs. There are two patents protecting this drug and three Paragraph IV challenges.

This drug has ninety-six patent family members in forty-eight countries and five supplementary protection certificates in four countries.

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

Summary for Tradename: EPIVIR

US Patents:2
Applicants:2
NDAs:4
Suppliers / Packagers: see list5
Bulk Api Vendors: see list87
Clinical Trials: see list28
Patent Applications: see list2,054
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EPIVIR at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 1995ABRXYesNo► Subscribe► Subscribe ► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 1995AARXYesYes► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-003Jun 24, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998ABRXYesYes► Subscribe► Subscribe ► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 1995ABRXYesNo► Subscribe► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-003Jun 24, 2002ABRXYesYes► Subscribe► Subscribe ► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 1995AARXYesYes► Subscribe► Subscribe ► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 1995AARXYesYes► Subscribe► SubscribeY► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 1998RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: EPIVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 1995► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 1995► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 1995► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-003Jun 24, 2002► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 1995► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 1995► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-003Jun 24, 2002► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 1995► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-003Jun 24, 2002► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for EPIVIR

Drugname Dosage Strength RLD Submissiondate
lamivudineTablets100 mgEpivir-HBV10/31/2007
lamivudineTablets150 mg and 300 mgEpivir10/16/2007
lamivudineOral Solution10 mg/mLEpivir11/22/2011

International Patent Family for Tradename: EPIVIR

Country Document Number Estimated Expiration
Norway922182► Subscribe
United Kingdom9111902► Subscribe
Ireland921780► Subscribe
Bulgaria60914► Subscribe
Austria212630► Subscribe
Eurasian Patent Organization001990► Subscribe
Iceland5184► Subscribe
Eurasian Patent Organization199900757► Subscribe
Estonia9900440► Subscribe
Bulgaria103818► 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

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
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
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/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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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Federal Trade Commission
Chinese Patent Office
Cipla
McKesson
Merck
McKinsey
Johnson and Johnson
AstraZeneca
Accenture

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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