Global pharmaceutical giant Lupin Limited (Lupin) announced today that it has received tentative approval from the United States 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. This approval allows Lupin to market a generic equivalent of Triumeq PD® Tablets for Oral Suspension, a product from ViiV Healthcare Company.

The generic version of this fixed-dose combination is designed to treat HIV-1 infection in pediatric patients aged 3 months and older, with a body weight of at least 6 kg. The once-daily, single-pill regimen contains Abacavir 60 mg, Dolutegravir 5 mg, and Lamivudine 30 mg, offering an effective treatment option for children with HIV.

Lupin will manufacture the product at its state-of-the-art facility in Nagpur, India. The product, which is a critical part of Lupin's growing portfolio in the HIV space, will provide a more affordable alternative to Triumeq PD® Tablets, which had an estimated annual sale of USD 1.3 million in the U.S. as of September 2024, according to IQVIA MAT data.

Lupin's CEO, Nilesh Gupta, commented on the development: "We are pleased to receive tentative approval for this important pediatric HIV treatment. This approval reflects our continued commitment to improving access to life-saving therapies for patients in need, especially children. We believe this product will provide significant value to families affected by HIV and help meet the growing demand for affordable treatment options."

This approval strengthens Lupin’s position in the global HIV treatment market, particularly in the pediatric segment, where treatment options remain limited and costly. The company’s strategic focus on high-quality, affordable generics aims to reduce the financial burden on patients and healthcare systems, ensuring better access to essential medicines.

In the United States, the market for HIV treatments, including pediatric options, remains significant. As per IQVIA data, the original branded product, Triumeq PD® Tablets for Oral Suspension, continues to generate substantial sales, highlighting the need for alternative treatment options to ensure broader access and affordability.

Lupin's Abacavir, Dolutegravir, and Lamivudine Tablets for Oral Suspension will be available for prescription once the product reaches the market. The company is working closely with regulatory bodies and stakeholders to ensure the timely availability of this much-needed treatment for children living with HIV in the U.S.

This approval comes as part of Lupin’s ongoing efforts to expand its global presence in the HIV treatment space, offering affordable alternatives to patients worldwide.