Lupin gets tentative USFDA nod for liver disease drug

The drug maker on Thursday announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA), Obeticholic Acid Tablets.

Obeticholic acid is used alone or in combination with ursodiol (Actigall, Urso) to treat primary biliary cholangitis (PBC; a type of liver disease that destroys bile ducts, which allows bile to stay in the liver and cause damage). Obeticholic acid is in a class of medications called farnesoid X receptor agonists. It works by decreasing the production of bile in the liver and increasing the removal of bile from the liver.

The approved ANDA is a generic equivalent of Ocaliva Tablets of Intercept Pharmaceuticals, Inc.

According to IQVIA MAT December 2022 data, Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of $255 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 U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company reported 71.9% drop in net profit to Rs 153.5 crore despite of 3.8% rise in net sales to Rs to Rs 4,244.6 crore in Q3 FY23 over Q3 FY22.

Shares of Lupin were up 0.23% to Rs 650 on the BSE.

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