Lupin Receives Tentative Approval For Empagliflozin And Metformin Hydrochloride ER Tablets

Lupin Limited (Lupin), global pharmaceutical company, announced today that it has received tentative approval for its Empagliflozin and Metformin Hydrochloride Extended-Release (ER) Tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, from the United States Food and Drug Administration, to market a generic equivalent of Synjardy XR Tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. The product will be manufactured at Lupin’s Nagpur facility in India.

Empagliflozin and Metformin Hydrochloride Extended-Release (ER) Tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, are indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate.

Empagliflozin and Metformin Hydrochloride ER Tablets (RLD: Synjardy XR) had estimated annual sales of USD 357 million in the U.S. (IQVIA MAT November 2020).