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 (ANDA) for Darunavir Tablets, 600 mg and 800 mg, a generic equivalent of Prezista® Tablets of Janssen Products, LP. Lupin is the exclusive first filer for 800 mg tablets and is eligible for 180-day exclusivity. Lupin will also potentially have shared 180-day exclusivity on the 600 mg tablets. The product will be manufactured at Lupin's facility in Nagpur, India.
Darunavir Tablets, 600 mg and 800 mg, (RLD Prezista®) had estimated annual sales of USD 343 million in the U.S. (IQVIA MAT June 2022).