Lupin Receives Approval From U.S. FDA For Pirfenidone Tablets

Global pharma major Lupin Limited on Friday 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, through an exchange filing. 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).

Lupin earlier this month announced the acquisition of diabetes brands ONDERO and ONDERO MET, from Boehringer Ingelheim International GmbH (Boehringer Ingelheim), including the trademark rights associated with these brands.

Lupin shares

The shares of Lupin Limited on Friday afternoon at 1:20 pm IST were trading at Rs 1,079.70, down by 0.90 per cent.