Novartis Faces Another Challenge To Entresto In India
Torrent Seeks Patent Revocation
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.
You may also be interested in...
There’s been a significant twist in the Entresto case in India with Novartis securing a patent, but can that put off the launch of generic versions of the blockbuster heart failure therapy later this month?
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.
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.