Teva Pharmaceutical Industries Ltd. (TEVA, TEVA.TV) said an appeals court upheld a federal judge's ruling that
Bristol-Myers Squibb Co.'s ( BMY ) patent for hepatitis B treatment Baraclude is invalid, allowing Teva to sell a generic
version.
Teva said its abbreviated new drug application for its generic copy had received tentative approval from the U.S. Food
and Drug Administration, and that it would finalize its launch plans after getting final FDA approval.
The Israel-based drug maker had challenged a patent for Baraclude in filing an application to the FDA to sell a
generic version of the drug before the patent expires in February 2015. Bristol-Myers filed a patent-infringement
lawsuit against Teva in 2010 in U.S. District Court in Delaware to keep Teva's product off the market until the patent
expires, but in February 2013 a judge ruled the patent was invalid.
Labels: Baraclude (Entacavir), generic Baraclude, patent