Novartis plans generic Lotrel launch
Yesterday the US District Court for the District of New Jersey vacated a restraining order against Teva Pharmaceuticals, freeing the company to resume shipping generic Lotrel. The Israeli firm received FDA approval for the generic in May and began shipping the drug before a temporary restraining order clamped new deliveries.
Novartis vowed to launch an authorized copy through its
Sandoz division but to continue
pursuing its defense of intellectual property rights, as Lotrel has a
Since the underlying patent challenge is unresolved, Teva’s Lotrel launch is at-risk, meaning it could face damages should the court rule in Novartis’ favor. A trial date has not been set.
Branded Lotrel had sales of $1.35 billion in 2006. Novartis said it is evaluating the potential impact of Teva’s actions on its full-year 2007 net sales.
Lotrel, which is only sold in the