Novartis is planning an immediate US launch of generic Lotrelafter a federal judge declined to stop a rival’s copies from entering themarket.
Yesterday the US District Court for the District of NewJersey vacated a restraining order against Teva Pharmaceuticals, freeing thecompany to resume shipping generic Lotrel. The Israeli firm received FDAapproval for the generic in May and began shipping the drug before a temporaryrestraining order clamped new deliveries.
The New Jerseycourt also denied a Novartis motion for a preliminary injunction in an ongoing patentdispute between the companies.
Novartis vowed to launch an authorized copy through itsSandoz division but to continuepursuing its defense of intellectual property rights, as Lotrel has a US patent validuntil 2017, the Swiss drug firm said.
Since the underlying patent challenge is unresolved, Teva’s Lotrellaunch is at-risk, meaning it could face damages should the court rule inNovartis’ favor. A trial date has not been set.
Branded Lotrel had sales of $1.35 billion in 2006. Novartis saidit is evaluating the potential impact of Teva’s actions on its full-year 2007net sales.
Lotrel, which is only sold in the US, combines ACE inhibitorbenazepril with calcium channel blocker amlodipine besylate, both of which areoff-patent.
