Lupin has secured tentative approval from the United States Food and Drug Administration (US FDA)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, Inc.

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.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the US by prescriptions. The company invested 7.8 percent of its revenue in research and development in FY24.