Bayer's $4 Billion Antithrombotic Drug Rivaroxaban Faces Market Disruption as Five Chinese Generics Including Qilu and Dong阳光 Receive Same-Day Approval

On May 24, according to the official website of the National Medical Products Administration (NMPA), five companies, including Qilu Pharmaceutical, Dongguan Yangzhikang Medicine Co., Ltd., and JIUDIAN PHARMACEUTICAL, simultaneously received marketing approval for Rivaroxaban Tablets. Data from Menet indicates that in 2020, the combined sales of Rivaroxaban Tablets in China's public medical institutions and urban retail pharmacies reached nearly RMB 4 billion.

Information Release on Drug Approval Documents Ready for Collection on May 24, 2021

According to available information, rivaroxaban tablets, co-developed by Bayer and Janssen Pharmaceuticals, are a novel oral anticoagulant. It primarily exerts its anticoagulant effect by inhibiting the activity of coagulation factor Xa, thereby reducing the generation of thrombin (coagulation factor IIa), without affecting the activity of preformed thrombin.

Sales Performance of Rivaroxaban Tablets in Chinese Public Medical Institutions and Urban Retail Pharmacy Terminals

Source: MENET Database

Data from Menet shows that in recent years, the combined sales of rivaroxaban tablets at Chinese public medical institution terminals (collectively referring to urban public hospitals, county-level public hospitals, urban community centers, and township health clinics) and Chinese urban physical pharmacy terminals reached nearly RMB 4 billion, with Bayer holding the largest market share.

Previously, there were already nearly 20 manufacturers of rivaroxaban tablets. This time, five companies, including Qilu Pharmaceutical, Dongguan Yangzhikang Medicine Co., Ltd., and JIUDIAN PHARMACEUTICAL, were approved via Class 4 generic marketing applications, which are deemed to have passed the consistency evaluation. Currently, marketing applications for this product from over 10 other companies, including Nanjing Hengsheng Pharmaceutical, Changzhou Pharmaceutical Factory, and Shaanxi Buchang High-Tech Pharmaceutical, remain under review and approval at the Center for Drug Evaluation (CDE).

Source: Official Website of the National Medical Products Administration, MENET Database