Lupin : March 23, 2023 Lupin Receives Tentative Approval from U.S. FDA for Obeticholic Acid Tablets

Mumbai, Baltimore, March 23, 2023: 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 (ANDA), Obeticholic Acid Tablets, 5 mg and 10 mg, to market a generic equivalent of Ocaliva® Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc.

Obeticholic Acid Tablets(RLDOcaliva®) had estimated annual sales of USD255million in the U.S. (IQVIA MAT December2022).

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 8.7% of its revenue in research and development in FY22.

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 -

Shweta Munjal
Vice President & Global Head - Corporate Communications
Email: [e-mail]

*Safe Harbor Statement
Ocaliva® is a registered trademark of Intercept Pharmaceuticals, Inc.

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