Novartis Cites ‘Same Labelling’ Rule In FDA Entresto Petition
‘At Least Entresto 18 ANDAs Have Been Submitted To FDA,’ Novartis Reveals
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.
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Entresto, one of the major small molecule opportunities for ANDA sponsors in the US, has seen a key patent knocked out following a challenge by generics manufacturers.
Having strongly made the case for Jardiance as a treatment for chronic heart failure, Boehringer Ingelheim and Eli Lilly believe the SGLT2 inhibitor could have a lot of potential in acute heart failure as well after promising data from the EMPULSE study.
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.