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Lamivudine - Generic Drug Details

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

This ingredient has ninety-two patent family members in forty-eight countries.

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

Summary for Generic Name: lamivudine

Tradenames:6
Patents:7
Applicants:13
NDAs:22
Drug Master File Entries: see list26
Suppliers / Packaging: see list19
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Tentative approvals for LAMIVUDINE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL150MG; 300MG; 200MG
<disabled><disabled>TABLET; ORAL150MG; 300MG; 200MG
<disabled><disabled>TABLET; ORAL150MG; 300MG; 600MG

Clinical Trials for: lamivudine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 1995RXNo5,905,082*PED<disabled>Y<disabled>
Glaxosmithkline
EPIVIR-HBV
lamivudine
TABLET;ORAL021003-001Dec 8, 1998RXYes5,905,082*PED<disabled>Y<disabled>
Merck Sharp Dohme
DUTREBIS
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015DISCNNo7,217,713<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: lamivudine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
EPIVIR
lamivudine
TABLET;ORAL020564-001Nov 17, 19957,119,202*PED<disabled>
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 19957,119,202*PED<disabled>
Viiv Hlthcare
EPIVIR
lamivudine
SOLUTION;ORAL020596-001Nov 17, 19955,047,407*PED<disabled>
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International Patent Family for Ingredient: lamivudine

Country Document Number Estimated Expiration
South Africa9204007<disabled in preview>
Germany69232387<disabled in preview>
Denmark0969815<disabled in preview>
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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
80018Netherlands<disabled>PRODUCT NAME: LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001-002 19980318
C0020Belgium<disabled>PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
C/GB96/043United Kingdom<disabled>PRODUCT 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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