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 Obeticholic Acid Tablets, 5 mg and 10 mg, a generic equivalent of Ocaliva® Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc. This product will be manufactured at Lupin's Nagpur facility in India.

Obeticholic Acid Tablets (RLD Ocaliva®) had estimated annual sales of USD 262 million in the U.S. (IQVIA MAT Mar 2023).