Lupin has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Abacavir, Dolutegravir, and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg. The approval allows Lupin to market a generic version of ViiV Healthcare’s Triumeq PD Tablets for Oral Suspension. The product will be manufactured at Lupin’s facility in Nagpur, India.
The fixed-dose combination of Abacavir 60 mg, Dolutegravir 5 mg, and Lamivudine 30 mg for oral suspension is a once-daily regimen. It is indicated for the treatment of HIV-1 infection in pediatric patients who are at least three months old and weigh at least 6 kg.
The reference listed drug, Triumeq PD, had estimated annual sales of USD 1.3 million in the U.S. as of September 2024, according to IQVIA data.