Global pharmaceutical major Lupin Limited announced today that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Raltegravir Tablets USP, 600 mg. These tablets are the generic equivalent of Isentress® HD Tablets, 600 mg, originally developed by Merck Sharp & Dohme LLC.
Lupin holds the exclusive first-to-file status for this product, making it eligible for 180 days of generic drug exclusivity in the U.S. market. The product will be manufactured at Lupin’s state-of-the-art facility in Nagpur, India.
Raltegravir Tablets USP, 600 mg are indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients and pediatric patients weighing at least 40 kg.
According to industry estimates, Raltegravir Tablets USP, 600 mg (reference listed drug Isentress® HD) recorded annual sales of approximately USD 34 million in the U.S.
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 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
