Shanghai’s Sunshine Medical Procurement All-In-One (SMPA) announced the suspension of procurement for indobufen, manufactured by Hunan Jiudian Pharmaceutical and Zhejiang Tongwu Biomedical, following a patent infringement verdict by the Hangzhou Intellectual Property Office. The decision highlights ongoing disputes over the drug’s patent status in China.
Background
Indobufen, an isoindolylphenylbutyric acid derivative used for ischemic cardiovascular and cerebrovascular diseases, is not yet marketed in China. The originator, Farmfalia Carlo Erba (acquired by Pfizer), holds no local listing. Local firm Huadong Medicine owns a patent for “Crystal Form X and D of Indobufen” (ZL 202011484428.X), valid until 2040. Since crystal form patents are excluded from patent linkage, other generics have filed Class 1 patent declarations.-Fineline Info & Tech
