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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Citi
Daiichi Sankyo
Covington
Moodys
Fish and Richardson
Argus Health
UBS
Chinese Patent Office
Mallinckrodt

Generated: December 16, 2017

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

Lamivudine has ninety-seven patent family members in forty-eight countries and five supplementary protection certificates in four countries.

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

Medical Subject Heading (MeSH) Categories for lamivudine

Tentative approvals for LAMIVUDINE

Applicant Application No. Strength Dosage Form
u► Subscribe150MG; 300MG; 200MGTABLET; ORAL
u► Subscribe150MG; 300MG; 600MGTABLET; ORAL
u► 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
Viiv HlthcareEPIVIRlamivudineTABLET;ORAL020564-001Nov 17, 1995ABRXYesNo► Subscribe► Subscribe► Subscribe
Viiv HlthcareEPIVIRlamivudineTABLET;ORAL020564-003Jun 24, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
Viiv HlthcareEPIVIRlamivudineTABLET;ORAL020564-001Nov 17, 1995ABRXYesNo► Subscribe► Subscribe► Subscribe
Silarx Pharms IncLAMIVUDINElamivudineSOLUTION;ORAL203564-001Oct 31, 2014AARXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdLAMIVUDINE AND ZIDOVUDINElamivudine; zidovudineTABLET;ORAL077558-001May 5, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Viiv HlthcareEPIVIRlamivudineTABLET;ORAL020564-003Jun 24, 2002ABRXYesYes► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdLAMIVUDINElamivudineSOLUTION;ORAL077695-001Nov 21, 2016AARXNoNo► Subscribe► Subscribe► Subscribe
Lupin LtdLAMIVUDINElamivudineTABLET;ORAL205217-001Dec 18, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Viiv HlthcareEPIVIRlamivudineSOLUTION;ORAL020596-001Nov 17, 1995AARXYesYes► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeDUTREBISlamivudine; raltegravir potassiumTABLET;ORAL206510-001Feb 6, 2015DISCNNoNo► Subscribe► SubscribeY► 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 HlthcareEPIVIRlamivudineTABLET;ORAL020564-003Jun 24, 2002► Subscribe► Subscribe
Viiv HlthcareEPIVIRlamivudineTABLET;ORAL020564-001Nov 17, 1995► Subscribe► Subscribe
GlaxosmithklineEPIVIR-HBVlamivudineSOLUTION;ORAL021004-001Dec 8, 1998► Subscribe► Subscribe
Viiv HlthcareEPIVIRlamivudineSOLUTION;ORAL020596-001Nov 17, 1995► Subscribe► Subscribe
GlaxosmithklineEPIVIR-HBVlamivudineTABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
GlaxosmithklineEPIVIR-HBVlamivudineTABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
GlaxosmithklineEPIVIR-HBVlamivudineSOLUTION;ORAL021004-001Dec 8, 1998► Subscribe► Subscribe
GlaxosmithklineEPIVIR-HBVlamivudineSOLUTION;ORAL021004-001Dec 8, 1998► Subscribe► Subscribe
GlaxosmithklineEPIVIR-HBVlamivudineTABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
GlaxosmithklineEPIVIR-HBVlamivudineTABLET;ORAL021003-001Dec 8, 1998► Subscribe► Subscribe
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International Patent Family for Ingredient: lamivudine

Country Document Number Estimated Expiration
Bulgaria98254► Subscribe
Portugal969815► Subscribe
Canada2070230► Subscribe
Bulgaria60914► Subscribe
Bulgaria103818► Subscribe
Australia656379► Subscribe
New Zealand242981► Subscribe
Australia1881092► Subscribe
Czech Republic9903403► Subscribe
Indonesia29294► 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
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
C0020Belgium► SubscribePRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

QuintilesIMS
Citi
Julphar
Chubb
Harvard Business School
Daiichi Sankyo
Fuji
Medtronic
Healthtrust
Covington

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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