Nanjing F&S Pharmatech Co., Ltd has officially launched its generic version of Novartis’s heart failure therapy Entresto (sacubitril, valsartan) in China, with exclusive commercialization rights held by Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196). Entresto, a breakthrough treatment for chronic heart failure, was first approved in China in 2017 and later for primary hypertension in June 2021. The drug achieved sales of nearly RMB 3 billion (USD 415 million) in China last year.
CSPC Pharmaceutical Group Ltd’s (HKG: 1093) generic version became the second to receive generic quality consistency evaluation (GQCE) certification in China in August 2023, followed by Chia Tai Tianqing’s generic version in September.
According to the Orange Book, six patents related to the drug are registered in China, all focusing on “Pharmaceutical composition containing valsartan and NEP inhibitor” (Patent No.: ZL201110029600.7). This patent was invalidated in April 2017, a decision reaffirmed by CNIPA in 2018 and upheld by the People’s Court in 2019. However, this did not clear the way for generic entry, as CNIPA confirmed the drug’s core patent validity in 2021. The 20-year patent protection for Entresto’s core patents is set to expire on November 8, 2026.
Novartis stated on August 28, 2023, that Entresto’s active ingredients, sacubitril + valsartan, are still protected by patents No. ZL200680001733.0 and ZL201210191052.2 in China, both valid through November 2026. Novartis maintains the right to assert its patent rights against infringing generics through relevant judicial and/or administrative channels.- Flcube.com
