Lupin bags USFDA approval for Darunavir Tablets; Stock soars near 3%

4 Oct 2022 , 03:10 PM

Global pharma major Lupin Limited (Lupin) on Tuesday 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.

The pharma-major 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).

At around 3:00 PM, Lupin Ltd is currently trading at Rs742.45 per share up by Rs19.85 or 2.75% from its previous closing of Rs722.60 per share on the BSE.

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