Lupin Launches Generic Raltegravir in United States
Lupin has received FDA approval to market 600 mg Raltegravir tablets in the U.S. As the first generic manufacturer to file, the firm secures 180-day market exclusivity.
Lupin Limited has begun distributing 600 mg Raltegravir tablets in the U.S. following regulatory approval from the Food and Drug Administration (FDA). The product is a generic equivalent to the Isentress HD tablets manufactured by Merck Sharp & Dohme.
By filing as the first generic manufacturer, Lupin has secured 180-day market exclusivity for the product. This regulatory status provides the company a temporary advantage in the U.S. market, where the annual sales for the branded version were estimated at $26 million for the period ending September 2026, according to IQVIA.
The medication is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. This launch expands Lupin's portfolio of generic medicines as it continues to compete in the U.S. healthcare sector.