Mumbai, Naples, December 06, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, to market a generic equivalent of Triumeq PD® Tablets for Oral Suspension, of ViiV Healthcare Company. This product would be manufactured at Lupin’s Nagpur facility in India.

The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen, indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and weighing at least 6 kg.

Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension, 60 mg/5 mg/30 mg, (RLD Triumeq PD®) had an estimated annual sale of USD 1.3 million in the U.S. (IQVIA MAT September 2024).

About Lupin
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

For further information or queries please contact:

Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com

*Safe Harbor Statement
Triumeq PD® is a registered trademark of ViiV Healthcare Company