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news.A US federal judge has ruled that Teva Pharmaceutical Industries cannot launch a version of Helsinn Healthcare's Aloxi antinausea drug until its patent protection expires in 2024.
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Helsinn Healthcare together with Roche Palo Alto filed an infringement lawsuit against Teva Pharmaceuticals USA and Teva Pharmaceutical Industries (collectively Teva) in the US.
The US District Court for the District of New Jersey ruled that the patents at issue are valid and are infringed.
The term of the formulation patent rights and pediatric exclusivity currently provides coverage for Aloxi through to 30 July 2024.
Since 2011, Helsinn and Roche filed patent infringement lawsuits in the US against Dr. Reddy’s Laboratories, Sandoz and Teva, who submitted abbreviated new drug applications (ANDAs) for Aloxi.
Helsinn has already made settlements with Sandoz and Dr. Reddy’s, under which neither of the companies will be allowed to launch a generic version of palonosetron hydrochloride through an ANDA before 30 September 2018, except under several circumstances.
The remaining lawsuits are currently being disputed in US District Courts.
ALoxi is an anti-nausea medication also known as an antiemetic. In adults, it is used to help avoid symptoms of chemotherapy-induced nausea and vomiting in a single intravenous dose by blocking the effects of serotonin.