Mumbai, Baltimore, January 18, 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 for Febuxostat Tablets, 40 mg and 80 mg, to market a generic equivalent of Uloric® Tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals U.S.A., Inc. The product will be manufactured at Lupin’s Pithampur facility in India.

Febuxostat Tablets, 40 mg and 80 mg, are indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

Febuxostat Tablets(RLD Uloric®) had estimated annual sales of USD27 million in the U.S. (IQVIA MATNovember2023).

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
Uloric® is a registered trademark of Teijin Kabushiki Kaisha (Teijin Limited)