Epivir-hbv is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in EPIVIR-HBV is lamivudine. There are twenty-four drug master file entries for this compound. Nine suppliers are listed for this compound. There are fifty-nine tentative approvals for this compound. Additional details are available on the lamivudine profile page.
|Suppliers: see list||3|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|SOLUTION;ORAL||021004||Dec 8, 1998||RX||Yes||6,004,968*PED||<disabled>||Y||<disabled>|
|SOLUTION;ORAL||021004||Dec 8, 1998||RX||Yes||RE39155*PED||<disabled>||<disabled>|
|TABLET;ORAL||021003||Dec 8, 1998||RX||Yes||5,905,082*PED||<disabled>||Y||<disabled>|
|TABLET;ORAL||021003||Dec 8, 1998||RX||Yes||RE39155*PED||<disabled>||<disabled>|
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