Lupin bags USFDA nod for HIV drug Darunavir
The product will be manufactured at Lupin's facility in Nagpur, India.
Mumbai: Global pharma major, Lupin Limited, today announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darunavir Tablets, 600 mg and 800 mg.
The product 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).
Lupin 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.
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).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. 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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas.
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