Novartis is planning an immediate US
launch of generic Lotrel
after a federal judge declined to stop a rival’s copies from entering the
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.
The New Jersey
court also denied a Novartis motion for a preliminary injunction in an ongoing patent
dispute between the companies.
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 US patent valid
until 2017, the Swiss drug firm said.
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
Lotrel, which is only sold in the US, combines ACE inhibitor
benazepril with calcium channel blocker amlodipine besylate, both of which are