The FDA confirmed that Lupin’s generic formulation is therapeutically equivalent to Wakix, a product currently registered to Bioprojet Europe, Ltd. This approval enables the company to expand its presence in the central nervous system therapy sector, a key segment of its global portfolio.

Lupin operates an extensive network spanning 15 manufacturing sites and 6 research centers, employing more than 26,000 people worldwide. By adding this generic to its U.S. offerings, the company reinforces its strategy of providing affordable alternatives across complex therapy areas including cardiovascular, respiratory, and diabetic care.