Lupin : March 28, 2024 Lupin Receives Approval from U.S. FDA for Eslicarbazepine Acetate Tablets

Mumbai, Naples, March 28, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, to market a generic equivalent of Aptiom® Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, of Sumitomo Pharma America, Inc. Lupin is one of the first ANDA applicants and may be eligible for 180 days of shared generic exclusivity. The product will be manufactured at Lupin's Pithampur facility in India.

Eslicarbazepine Acetate Tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

Eslicarbazepine Acetate Tablets (RLD Aptiom®) had estimated annual sales of USD 354 million in the U.S. (IQVIA MAT January 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 7.9% of its revenue in research and development in FY23.

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: heenadhedhi@lupin.com

*Safe Harbor Statement
Aptiom® is a registered trademark of Bial - Portela & C^a. S.A.