Abacavir sulfate/Dolutegravir sodium/Lamivudine

The approval covers dosages of the medicine comprising 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg. Credit: Shidlovski/Shutterstock. The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin ’s Sacubitril and Valsartan tablets for heart failure patients. Sacubitril and Valsartan tablets are the generic equivalent of Novartis ‘ Entresto, used to reduce cardiovascular risks in adults with chronic heart failure and decreased ejection fraction. The approval covers dosages of 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg. They are also used for treating symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older. The tablets are expected to tap into a market with annual US sales of $6.06bn. The company has also announced the receipt of tentative approval from the US regulator under the US President’s Emergency Plan for AIDS Relief (PEPFAR) for its Abacavir, Dolutegravir and Lamivudine tablets for oral suspension. This generic equivalent of ViiV Healthcare’s Triumeq PD tablets for oral suspension is set to be manufactured at the company’s Nagpur facility in India. The tablets are for distribution in low and middle-income nations. The Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg fixed-dose combo is intended for the treatment of human immunodeficiency virus (HIV)-1 infection in children aged three and above weighing at least 6kg, and is a once-a-day single-pill regimen. Lupin API Plus SBU head, global chief financial officer and executive director Ramesh Swaminathan stated: “We are committed to providing affordable and high-quality treatments for patients worldwide. The tentative approval from the US FDA for our Abacavir, Dolutegravir and Lamivudine tablets enables us to improve the well-being of paediatric patients with HIV-1, thereby significantly boosting our HIV medication portfolio.” In September 2024, the company entered a non-exclusive patent licence agreement with Takeda Pharmaceutical for the commercialisation of Vonoprazan tablets in India.

Lupin has been granted tentative approval from the United States Food and Drug Administration (US 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 US. Lupin 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 US 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.