Lupin has received approval from the United States Food and Drug Administration (USFDA) 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.
The company 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 $343 million in the U.S. (IQVIA MAT June 2022).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
