The China National Intellectual Property Administration (CNIPA) has announced a pivotal decision concerning the patent status of Dapagliflozin, a sodium-glucose co-transporter 2 (SGLT-2) inhibitor co-developed by Bristol-Myers Squibb and AstraZeneca. The patent (ZL202011290859.2) related to heart failure has been completely invalidated, while the chronic kidney disease patent (ZL202210071080.4) remains intact.
The invalidated patent, ZL202011290859.2, was significant for its indication in reducing cardiovascular death and progression of heart failure in patients with reduced ejection fraction, as well as improving heart failure symptoms. In contrast, the upheld patent ZL202210071080.4 covers the use of Dapagliflozin in mitigating the risk of various negative outcomes in chronic kidney disease patients, including decline in renal function, end-stage renal disease, cardiovascular and renal death, heart failure hospitalization, and all-cause mortality.
Originally approved in China in 2017, Dapagliflozin has been included in the National Reimbursement Drug List (NDRL) since 2019, marking a significant milestone for its accessibility and affordability. Since then, it has garnered four additional indication approvals, reinforcing its position in the market.- Flcube.com
