Zhejiang’s Provincial Center for Drug & Medical Device Procurement has issued a notification suspending the online trading qualifications for generic versions of Takeda’s (TYO: 4502) Nesina (alogliptin). The notice specifically targets products manufactured by Jiangsu Zhongtian Pharmaceutical Co., Ltd and Sinopharm Guorui Pharmaceutical Co. Ltd. This suspension is part of recent policies aimed at ensuring that intellectual property (IP) rights protections and ongoing disputes are reflected during centralized drug procurement. Products currently involved in legal disputes are to be barred from provincial tenders.
Background on Nesina
Nesina is a dipeptidyl peptidase-4 (DPP-4) inhibitor used to treat type 2 diabetes. It was first approved in Japan in 2010 and introduced to China in 2013. Takeda filed for an invention patent in China for the drug (Patent Three) in September 2006, based on which another four patents were filed, including Patent One and Patent Two. All five patents were authorized, with a validation period lasting until September 13, 2026.
Patent Challenges and Outcomes
Yabao Pharma challenged Patent One (No. ZL201210332271.8), Patent Two (No. ZL201210399309.3), and Patent Three (No. ZL200680042417.8), all named “Dipeptidyl peptidase inhibitors for the treatment of diabetes.” The challenges were respectively for the protection of the pharmaceutical composition containing alogliptin and carrier (Patent One), the pharmaceutical use of alogliptin for the preparation of treatment of type 2 diabetes (Patent Two), and the pharmaceutical composition of alogliptin in the form of a single dose of a specific specification (Patent Three). The outcomes were that Patent One was declared partially invalid (while keeping the technical scheme of combined medication), Patent Two was declared invalid overall, and Patent Three was confirmed to enjoy priority rights (remaining valid). Yabao Pharma’s product eventually became the generic of Nesina to be marketed in China in November 2019.
Market Landscape and Patent Declarations
Since then, Zhongtian Pharma and Sinopharm, among a total of eight companies, have had generic versions approved for marketing in China. Only Ideal Pharma and Xinhua Pharma have made patent declarations for the drug under China’s new patent linkage system. Both made Category 3 declarations, indicating that the generics applicants promise not to market the product before patent expiration.
DPP-4 Inhibitors in China
Six DPP-4 inhibitors, including MSD’s sitagliptin, BMS/AZ’s saxagliptin, Novartis’s vildagliptin, BI’s linagliptin, and Mitsubishi Tanabe’s teneligliptin, as well as alogliptin, are commercially available in China. Saxagliptin and vildagliptin were involved in the fifth and third volume-based procurement (VBP) rounds, and linagliptin was suspended for procurement due to an IP issue involving HEC.
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