BASEL - Novartis announced in a Tuesday press release that it has launched its own generic version of Lotrel in the United States through its Sandoz division after a federal court judge declined a request from Novartis to stop Teva Pharmaceuticals from resuming shipments of generic copies of the hypertension drug.
Novartis will continue pursuing its defense of Intellectual Property Rights (IPRs) for Lotrel since its US patent is still valid until 2017. The court's decision allows Teva to resume shipping generic copies of Lotrel. A trial date has not been set for the ongoing patent infringement lawsuit against Teva in a New Jersey federal court.
Teva, which began selling a generic version of Lotrel in the US in May 2007, risks potentially significant damages if Novartis prevails in patent litigation.
Lotrel, which is sold only in the US, combines in a single capsule the Angiotensin Converting Enzyme (ACE) inhibitor benazepril hydrochloride and the Calcium Channel Blocker (CCB) amlodipine besylate. Both of these active ingredients no longer have US patent protection.
As previously announced publicly, Novartis is evaluating the potential impact of Teva's actions on the full-year 2007 net sales, operating and net income results. Lotrel had 2006 annual sales of USD 1.35 billion. An update on the outlook for 2007 will be provided on July 17 when Novartis reports its 2007 first-half and second-quarter results.
Novartis is a world leader in offering medicines to protect health, cure disease and improve well-being.
