Global pharma major Lupin Limited on Monday announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg.
These tablets are the generic equivalents of Juluca Tablets, 50 mg/25 mg of ViiV Healthcare Company.
Dolutegravir and Rilpivirine Tablets, 50 mg/25 mg, (RLD Juluca) had estimated annual sales of USD 666 million in the U.S. (IQVIA MAT September 2022).
Dolutegravir and Rilpivirine are antiretroviral medications to treat HIV/AIDS infection.
Lupin has a diverse protfolio in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas.
Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 8.7 percent of its revenue in research and development in FY22.
