Lupin Limited received final USFDA approval for its Pitolisant Tablets. The approval covers the 4.45 mg and 17.8 mg dosage strengths.
This medication is a generic version of Harmony Biosciences' Wakix®. The treatment targets excessive daytime sleepiness in adult patients.
Lupin held tentative approval since March 2026 pending the resolution of patent litigation. The company will now proceed with the commercial launch in the United States.
Manufacturing will occur at the company's facility in Nagpur, India. This development enhances Lupin's presence in the U.S. generics market.