Novartis Secures Injunction Against Entresto Challengers In India
Novartis has secured an injunction order against alleged infringers of heart failure therapy Entresto in India. Court also makes key observations around the “scientific opinion”, which had gone in favor of challenger Natco.
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Ahead of a proposed patent infringement trial set for September 2022, Novartis is urging the FDA not to approve any generic versions of its blockbuster heart failure therapy Entresto before February 2024 at the earliest, in part because of the agency’s own ‘same labelling’ regulations for ANDA products.
More patent-related turbulence appears ahead for Novartis’s sacubitril/valsartan combination in India, with Torrent emerging as the new challenger. The companies are engaged in a legal battle and the Indian firm is also seeking a revocation of the patent on the star heart failure treatment.
Natco has launched a cut-price version of sacubitril/valsartan (Novartis' Entresto) on the Indian market and is also believed to have opposed the patent for the heart failure therapy.