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Details for Generic Name: lamivudine

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

There are twenty-four drug master file entries for lamivudine. Nine suppliers are listed for this compound. There are sixty tentative approvals for this compound.

Summary for Generic Name: lamivudine

Drug Master File Entries: see list24
Suppliers: see list9
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
Hetero Labs Ltd V
TABLET;ORAL203277-001Jan 6, 2014RXNo<disabled><disabled>
SOLUTION;ORAL021004-001Dec 8, 1998RXYes6,004,968*PED<disabled>Y<disabled>
Aurobindo Pharma Ltd
lamivudine; zidovudine
TABLET;ORAL202418-001May 15, 2012RXNo<disabled><disabled>
Viiv Hlthcare
TABLET;ORAL020564-003Jun 24, 2002RXYes5,905,082*PED<disabled>Y<disabled>
Merck Sharp Dohme
lamivudine; raltegravir potassium
TABLET;ORAL206510-001Feb 6, 2015RXYes7,754,731<disabled>YY<disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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