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).