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Novartis Faces Another Challenge To Entresto In India

Torrent Seeks Patent Revocation

Executive Summary

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.

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Torrent expects US FDA’s final approval for Allergan/Almirall’s Aczone, a dapsone formulation for acne vulgaris, in February, even as it awaits regulatory clearance for manufacturing sites. Meanwhile, it has launched molnupiravir in India and is hiking its domestic sales force by 400-500.

Novartis Cites ‘Same Labelling’ Rule In FDA Entresto Petition

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.

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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