Teva to move forward with generic equivalent of BMS' Baraclude
JERUSALEM — Teva Pharmaceutical Industries on Thursday announced that the U.S. Court of Appeals for the Federal Circuit upheld a ruling by the U.S. District Court for the District of Delaware finding Bristol-Myers Squibb's entecavir compound claim of U.S. Patent No. 5,206,244 invalid.
Teva's abbreviated new drug application for entecavir, the generic equivalent to Baraclude (a medicine prescribed to treat chronic hepatitis B) has received tentative approval from the Food and Drug Administration. Teva will finalize the launch plans for this product once it receives final approval from the FDA.
Baraclude is marketed in the U.S. by Bristol-Myers Squibb and had annual sales of approximately $314 million in the United States, according to IMS data as of March 2014, Teva reported.