Lupin gains on bagging US FDA nod for HIV treatment drug

Shares of the global pharma major Lupin advanced 1.67% to Rs 734.65 after the company announced that it has received approval from the United States Food and Drug Administration (US FDA) for its ANDA for Darunavir Tablets, 600 mg and 800 mg.

The approved abbreviated new drug application (ANDA) is a generic equivalent of Prezista Tablets of Janssen Products, LP.

Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS).

Darunavir Tablets, 600 mg and 800 mg, (reference listed drug: Prezista) had estimated annual sales of $343 million in the U.S. (IQVIA MAT June 2022).

Lupin is the exclusive first filer for 800 mg tablets and is eligible for 180-day exclusivity. The company 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, the drug maker said in a statement.

Lupin is an innovation-led transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The drug maker reported a net loss of Rs 89.1 crore in Q1 FY23 as against a net profit of Rs 542.5 crore in Q1 FY22. Total revenue from operations declined 12.3% YoY to Rs 3,743.8 crore during the quarter.

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