Lupin obtains FDA approval for generic version of Ocaliva Tablets

Indian pharmaceutical company Lupin has announced its approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Obeticholic Acid Tablets, 5 mg and 10 mg.

In March 2023, Lupin was issued tentative approval for Obeticholic Acid Tablets, 5 mg and 10 mg from the FDA.

These tablets are the generic equivalent of Intercept Pharmaceuticals, Inc.’s Ocaliva Tablets, 5 mg, and 10 mg. Lupin will manufacture this product at its Nagpur facility located in India.

The approval from the FDA is a significant milestone for Lupin as it enables the company to introduce a cost-effective generic version of Ocaliva Tablets to the market. Ocaliva is widely used in the treatment of certain liver diseases, including primary biliary cholangitis.

According to IQVIA MAT Mar 2023 data, Ocaliva had estimated annual sales of $262 million in the US.

The approval of Lupin’s generic version of Ocaliva Tablets provides patients with increased accessibility to an affordable treatment option.