Lupin receives USFDA nod for new HIV drug

Lupin announced that it has received an approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets.

Emtricitabine and tenofovir alafenamide combination is used together with other medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection.

The said drug is the generic equivalent of Descovy Tablets of Gilead Sciences, Inc. Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity. This product will be manufactured at Lupins Nagpur facility in India.

 

Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It 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.

Lupins consolidated net profit jumped 74.1% to Rs 852.63 crore on 11.3% increase in sales to Rs 5,497.01 crore in Q2 FY25 over Q2 FY24.

Shares of Lupin shed 0.13% to currently trade at Rs 2,096 on the BSE.

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