Lupin receives US FDA approval for raltegravir tablets USP, 600 mg

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for raltegravir tablets USP, 600 mg.  Raltegravir tablets are bioequivalent to Isentress HD tablets, 600 mg of Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.
 
Raltegravir tablets USP, 600 mg are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients and in paediatric patients weighing at least 40 kg.
 
Raltegravir tablets USP, 600 mg (Isentress HD) had an estimated annual sale of USD 34 million in the US (IQVIA MAT March 2025).