July 9, 2024 Lupin Receives Tentative Approval from U.S. FDA for Empagliflozin, Linagliptin and Metformin Hydrochloride Extended-Release Tablets

Mumbai, Naples, July 09, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. 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 USD111million in the U.S. (IQVIA MAT April 2024).

About Lupin
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 U.S., 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 U.S. by prescriptions. The company invested 7.8% of its revenue in research and development in FY24.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.
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For further information or queries please contact -
Heena Dhedhi
Deputy General Manager - Corporate Communications
Email: [email protected]

*Safe Harbor Statement
Trijardy® is a registered trademark of Boehringer Ingelheim International GmbH.