Lupin gets USFDA nod for generic HIV drug

New Delhi, Oct 4: Drug firm Lupin on Tuesday said it has received an approval from the US health regulator to market Darunavir Tablets, used to treat Human Immunodeficiency Virus (HIV) infection, in the American market.
The Mumbai-based company said it 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, it added.
The company has received the approval from the US Food and Drug Administration (USFDA) for the medication in strengths of 600 mg and 800 mg, Lupin said.
The drug firm’s product is a generic equivalent of Janssen Products’ Prezista Tablets.
As per MAT June 2022 data, Darunavir tablets (600 mg and 800 mg) had estimated annual sales of USD 343 million in the US.