Being the first to file, Lupin is eligible for 180-day shared generic exclusivity

Mumbai, Naples, December 18, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg, to market a generic equivalent of Descovy® Tablets, 200 mg/25 mg of Gilead Sciences, Inc. Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity. This product will be manufactured at Lupin’s Nagpur facility in India.

Emtricitabine and Tenofovir Alafenamide Tablets are indicated for the treatment of HIV-1 Infection and for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection in adults and adolescents.

Emtricitabine and Tenofovir Alafenamide Tablets (RLD Descovy®) had estimated annual sales of USD 3,556 million in the U.S. (IQVIA MAT October2024).

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
Descovy® is a registered trademark of Gilead Sciences Ireland UC