Novartis plans generic Lotrel launch

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Novartis is planning an immediate US launch of generic Lotrelafter a federal judge declined to stop a rival’s copies from entering the market.

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 net sales.

Lotrel, which is only sold in the US, combines ACE inhibitor benazepril with calcium channel blocker amlodipine besylate, both of which are off-patent.

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