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 Pirfenidone Tablets, 267 mg and 801 mg, to market a generic equivalent of Esbriet Tablets, 267 mg and 801 mg of Hoffmann La Roche Inc.

This product will be manufactured at Lupin's Pithampur facility in India.

Pirfenidone Tablets (RLD Esbriet) had estimated annual sales of USD 218 million in the U.S. (IQVIA MAT June 2023).