Lupin Secures USFDA Approval for Generic Pitolisant

Lupin Limited has secured final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) to market generic Pitolisant Tablets in 4.45 mg and 17.8 mg strengths. Determined to be bioequivalent to the reference product Wakix—which is marketed by Harmony Biosciences—the medication is indicated for the treatment of excessive daytime sleepiness (EDS). This regulatory milestone significantly bolsters Lupin's generic portfolio in the crucial US healthcare market while broadening its therapeutic footprint in sleep-related disorders. The approval highlights Lupin's ongoing strategy to expand its lineup of specialized generic therapeutics across regulated global markets. By meeting rigorous USFDA equivalence standards through the ANDA pathway, the company introduces a viable generic alternative for patients experiencing excessive daytime sleepiness. This addition enables Lupin to capture market share within the US sleep-disorder segment, reinforcing the broader role of Indian pharmaceutical firms in delivering accessible, high-value generic medicines internationally.