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  • Entresto patent dispute near its end, yet 0 generic approval
  • by Kim, Jin-Gu | translator Hong, Ji Yeon | Oct 14, 2025 06:40am
Generic companies win successive disputes since 2021¡¦two rulings in the Supreme Court remain
10 companies have applied for marketing authorization, yet there are '0 approvals'
MFDS is requesting supplementary documentation¡¦'cocrystal' generic approval remains the key determinant
 ¡ã Product photo of Entresto
The patent dispute of Novartis' heart failure treatment, 'Entresto,' is nearing its final judgment. Still, generic companies may be unable to launch their products early, regardless of the ruling.

To launch a generic early, companies need not only to win the patent dispute but also to secure product approval from the Ministry of Food and Drug Safety (MFDS). The MFDS is reportedly demanding supplementary data from the relevant generic companies. In other words, generic manufacturers, after fighting patent battles for five years, risk winning the legal fight only to be unable to launch their product.


Not a simple combination drug but a 'cocrystal complex'...may be delaying generic approval

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