Qilu Pharmaceutical Submits China's First Generic NDA for Empagliflozin/Linagliptin Tablets for Type 2 Diabetes

On March 11, the CDE website showed that Qilu Pharmaceutical's Category 3 generic drug Empagliflozin and Linagliptin Tablets had been submitted for marketing approval for the treatment of Type 2 diabetes. Qilu Pharmaceutical is also the first pharmaceutical company in China to submit a marketing application for a compound generic version of Empagliflozin and Linagliptin.

The original research and development manufacturers of the compound Empagliflozin and Linagliptin (brand name: Glyxambi) are Boehringer Ingelheim and Eli Lilly. It contains two active ingredients: the SGLT2 inhibitor Empagliflozin and the DPP-4 inhibitor Linagliptin. In January 2015, Glyxambi was approved for marketing in the United States, with an indication to improve glycemic control in adult patients with type 2 diabetes as an adjunct to diet and exercise. According to publicly disclosed patent information, the pharmaceutical use patent for Glyxambi will expire in May 2027, and the composition patent will expire in October 2029.

On January 24, 2022, Huahai Pharmaceutical announced that its Empagliflozin and Linagliptin Tablets Abbreviated New Drug Application (ANDA) received tentative approval from the U.S. FDA (indicating that the FDA has completed all review requirements for the generic drug, but due to unexpired patents or exclusivity periods, this is a form of approval), but the product has not yet been filed for marketing in China.

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