The National Medical Products Administration (NMPA) website has indicated that Chia Tai Tianqing’s generic version of Swiss pharmaceutical giant Novartis’s heart failure therapy Entresto (sacubitril, valsartan) has been approved for marketing. However, the generic version will not be launched until 2026 when the originator’s patent expires. This follows the approval of generic versions from Nanjing F&S Pharmatech Co., Ltd and CSPC Pharmaceutical Group Ltd (HKG: 1093) in late August of this year.
Entresto’s Market Presence and Sales in China
Entresto, a breakthrough therapy for chronic heart failure, was first approved in China in 2017 and later for primary hypertension in June 2021. The drug generated close to RMB 3 billion (USD 415 million) in sales in China last year, highlighting its significance in the treatment of heart failure.
Patent Status and Generic Market Entry
The Orange Book lists six patents relating to the drug registered in China, all concerning “Pharmaceutical composition containing valsartan and NEP inhibitor” (Patent No.: ZL201110029600.7). Despite a patent being declared invalid in April 2017 and subsequent confirmations by CNIPA in 2018 and the People’s Court in 2019, this was not sufficient to allow generics onto the market. In 2021, CNIPA confirmed the drug’s core patent remained valid. The 20-year patent protection period for both of Entresto’s core patents is set to expire on November 8, 2026. According to Fineline Info & Tech’s DRUG IP RADAR, eight more companies have filed Category 3 patent declarations against the originator, indicating they will not launch until patent expiry.
Novartis’ Statement on Patent Protection and Market Launch
Novartis issued a statement on August 28, 2023, clarifying that Entresto’s active ingredients, sacubitril + valsartan, remain under the protection of patents No. ZL200680001733.0 and ZL201210191052.2 in China, both valid through November 2026. The company emphasized that no enterprise or individual shall manufacture, use, promise to sell, sell, or import products that fall within the scope of patent protection before the expiration of the mentioned patent period, unless authorized by Novartis. Novartis reserves the right to claim its patent rights against infringing imitations through relevant judicial and/or administrative authorities.-Fineline Info & Tech
