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Generic Baraclude (Entecavir) Tablets Launched in U.S.

Treatment targets hepatitis B virus infection

Teva Pharmaceutical Industries Ltd. has announced the launch of the generic equivalent to Baraclude (entecavir) tablets, 0.5 mg and 1.0 mg, in the U.S. Teva was the first to file, making the product eligible for 180 days of marketing exclusivity.

Baraclude tablets, 0.5 mg and 1.0 mg, marketed by Bristol-Myers Squibb, had annual sales of approximately $328 million in the U.S., according to IMS data as of June 2014.

Entecavir is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic HBV infection in adults with evidence of active viral infection and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The recommended dosage for chronic HBV infection in nucleoside inhibitor treatment-naïve adults and adolescents 16 years of age or older with compensated liver disease is 0.5 mg once daily.

The recommended dosage in adults and adolescents (at least 16 years of age) with compensated liver disease and a history of hepatitis B viremia while receiving lamivudine or lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1.0 mg once daily.

The recommended dosage of entecavir in adults with decompensated liver disease is 1.0 mg once daily.

Generic entecavir tablets are not labeled with information regarding the recommended dosage in pediatric patients.

Entecavir, a guanosine nucleoside analog with activity against HBV reverse transcriptase, is phosphorylated to the active triphosphate form, which has an intracellular half-life of 15 hours. By competing with the natural substrate deoxyguanosine triphosphate, entecavir triphosphate functionally inhibits the activities of HBV reverse transcriptase.

The labeling for generic entecavir includes a boxed warning regarding the potential for severe acute exacerbations of hepatitis B; use in patients with human immunodeficiency virus (HIV) and HBV; and lactic acidosis and hepatomegaly.

Sources: Teva Pharmaceuticals; September 4, 2014; and Entecavir Package Insert; July 2014.

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