Lupin gains tentative FDA approval for Empagliflozin, Linagliptin, Metformin Hydrochloride ER tablets

Lupin announced that it has received tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Empagliflozin, Linagliptin and Metformin Hydrochloride Extended-Release (ER) Tablets, 5 mg/2.5 mg/1,000 mg, 10 mg/5 mg/1,000 mg, 12.5 mg/2.5 mg/1,000 mg, and 25 mg/5 mg/1,000 mg, to market a generic equivalent of Trijardy XR Extended-Release Tablets, 5 mg/2.5 mg/1,000 mg, 10 mg/5 mg/1,000 mg, 12.5 mg/2.5 mg/1,000 mg, and 25 mg/5 mg/1,000 mg, of Boehringer Ingelheim Pharmaceuticals. This product will be manufactured at Lupin’s Pithampur facility in India. 

Empagliflozin, Linagliptin and Metformin Hydrochloride Extended-Release (ER) Tablets (RLD Trijardy XR) had an estimated annual sale of USD 111 million in the US (IQVIA MAT April 2024).