Lupin Limited, a global leader in the pharmaceutical industry, has announced it has secured tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application. This approval pertains to abacavir, dolutegravir, and lamivudine tablets for oral suspension at dosages of 60 mg/5 mg/30 mg. These tablets offer a generic alternative to ViiV Healthcare Company’s Triumeq PD tablets for oral suspension. The production of this medication will take place at Lupin’s facility located in Nagpur, India.
This medication provides a fixed-dose combination of abacavir 60 mg, dolutegravir 5 mg, and lamivudine 30 mg in a single, convenient oral suspension tablet intended for once-daily use. It is designed to treat HIV-1 infection in pediatric patients who are at least 3 months old and weigh a minimum of 6 kg.
In the United States, the abacavir, dolutegravir, and lamivudine tablets for oral suspension, branded as Triumeq PD, had an estimated annual revenue of USD 1.3 million as of IQVIA MAT September 2024.
Headquartered in Mumbai, India, Lupin Limited is a globally recognized pharmaceutical powerhouse, offering products across over 100 international markets. Lupin’s comprehensive portfolio includes branded and generic formulations, complex generics, biotechnology offerings, and active pharmaceutical ingredients.