Lamivudine is the generic ingredient in five 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, and Teva Pharms, and is included in sixteen NDAs. There are three 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 fifty-nine tentative approvals for this compound.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|TABLET;ORAL||020857||Sep 26, 1997||RX||Yes||5,905,082*PED||<disabled>||Y||<disabled>|
LAMIVUDINE AND ZIDOVUDINE
|TABLET;ORAL||079081||May 25, 2011||RX||No||<disabled>||<disabled>|
Silarx Pharms Inc
|SOLUTION;ORAL||203564||Oct 31, 2014||RX||No||<disabled>||<disabled>|
Aurobindo Pharma Ltd
|TABLET;ORAL||202032||Nov 17, 2011||RX||No||<disabled>||<disabled>|
|TABLET;ORAL||020564||Jun 24, 2002||RX||Yes||5,905,082*PED||<disabled>||Y||<disabled>|
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