Pharma stock in green after receiving approval from USFDA for new generic HIV tablets

Pharma stock surged nearly 2 percent on Thursday morning following the announcement of receiving U.S. FDA approval for its new HIV drug. The approval paves the way for the company to market its generic version of a widely used HIV treatment, enhancing its position in the competitive pharmaceutical market. 

Price Movement 

In Thursday’s trading session, Lupin Ltd’s shares reached an intra-day high of Rs.2,127.60 per share, rising from its previous close of Rs.2,099.10 each. The shares have retreated since then and currently trading at Rs.2,113.50 per share. Over the past year, the shares have delivered over 67 percent returns. 

What is the news 

Lupin has announced receiving approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets. 

This combination is used in conjunction with other medications to treat HIV infection, which causes AIDS, and is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection. The drug is a generic version of Gilead Sciences’ Descovy Tablets. 

Lupin, as one of the first ANDA applicants, is eligible for 180 days of shared generic exclusivity. The product will be manufactured at Lupin’s facility in Nagpur, India. 

Global Reach 

Lupin, based in Mumbai, is an innovation-driven global pharmaceutical company. It develops and markets a diverse range of branded and generic formulations, biotechnology products, and APIs across more than 100 markets, including the U.S., India, South Africa, and regions in Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East. 

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Business Development 

Lupin Ltd. recently completed Phase 3 trials for its Ranibizumab biosimilar. The company also acquired 9 brands from the Medical Nutritional Institute in South Africa and received approval from Canada Health for its biosimilar Pegfilgrastim. These developments mark key steps in Lupin’s ongoing expansion in the biosimilar and pharmaceutical markets. 

Financials 

For the quarter ended September 2024, Lupin Ltd reported revenue from operations of Rs.5,673 crore, a 13 percent rise compared to Rs.5,039 crore in Q2 FY24. Net profit stood at Rs.859 crore, marking a 74 percent incline from Rs.495 crore in the same period. 

About the company 

Lupin Ltd is a leading Indian multinational pharmaceutical company headquartered in Mumbai. It specializes in the development and manufacturing of a diverse range of pharmaceutical products, including generic and branded formulations, biotechnology products, and active pharmaceutical ingredients (APIs).

The company has a strong focus on therapeutic areas such as cardiovascular health, diabetes, and respiratory conditions. 

Written by – Siddesh S Raskar 

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