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Serving 500+ biopharmaceutical companies globally:

Dow
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UBS
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Generated: July 23, 2017

DrugPatentWatch Database Preview

Lamivudine - Generic Drug Details

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What are the generic drug sources for lamivudine and what is the scope of lamivudine patent protection?

Lamivudine
is the generic ingredient in six branded drugs marketed by Mylan Pharms Inc, Glaxosmithkline, Apotex, Lupin Ltd, Cipla Ltd, Aurobindo Pharma Ltd, Apotex Inc, Hetero Labs Ltd V, Silarx Pharms Inc, Viiv Hlthcare, Appco Pharma Llc, Centaur Pharms Pvt, Merck Sharp Dohme, Pharmacare, Hetero Labs Ltd Iii, Strides Pharma, and Teva Pharms, and is included in twenty-nine NDAs. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lamivudine has ninety-three patent family members in forty-eight countries.

There are twenty-seven drug master file entries for lamivudine. Twenty-five suppliers are listed for this compound. There are fifty tentative approvals for this compound.

Summary for Generic Name: lamivudine

Tradenames:6
Patents:8
Applicants:17
NDAs:29
Drug Master File Entries: see list27
Suppliers / Packagers: see list25
Bulk Api Vendors: see list86
Clinical Trials: see list514
Patent Applications: see list3,299
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:lamivudine at DailyMed

Tentative approvals for LAMIVUDINE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe150MG; 300MG; 200MGTABLET; ORAL
► Subscribe► Subscribe150MG; 300MG; 600MGTABLET; ORAL
► Subscribe► Subscribe150MG; 300MG; 300MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo7,217,713► Subscribe ► Subscribe
Aurobindo Pharma Ltd
LAMIVUDINE
lamivudine
TABLET;ORAL202032-002Nov 17, 2011ABRXNoNo► Subscribe► Subscribe
Lupin Ltd
LAMIVUDINE AND ZIDOVUDINE
lamivudine; zidovudine
TABLET;ORAL090246-001May 15, 2012ABRXNoNo► Subscribe► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 1995AARXYesYes6,004,968*PED► SubscribeY► Subscribe
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNoNo7,754,731► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 19957,119,202*PED► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998RE39155*PED► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 19955,905,082*PED► Subscribe
Glaxosmithkline
EPIVIR-HBV
lamivudine
SOLUTION;ORAL021004-001Dec 8, 19985,047,407*PED► Subscribe
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-003Jun 24, 20025,905,082*PED► Subscribe
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International Patent Family for Ingredient: lamivudine

Country Document Number Estimated Expiration
Mexico9202619► Subscribe
Denmark0517145► Subscribe
Cyprus2569► Subscribe
Peru61699► Subscribe
Singapore52455► 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: LAMIVUDINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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/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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Merck
Boehringer Ingelheim
Healthtrust
Colorcon
Daiichi Sankyo
Fuji
Novartis
Accenture
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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