Lupin Limited receives tentative approval from the U.S. Food and Drug Administration for its ANDA for Pitolisant Tablets 4.45 mg and 17.8 mg, the generic version of Wakix for excessive daytime sleepiness in narcolepsy.
Written By: Pharmacally Medical News Desk
Lupin Limited has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, 4.45 mg and 17.8 mg, the company announced.
This tentative approval allows Lupin to market its generic version of pitolisant once all regulatory requirements are met, including the expiration of any applicable patents or regulatory exclusivities on the reference product. The product is a generic version of Wakix® (pitolisant) and has been approved as bioequivalent to the reference listed drug in the approved labeling.
Pitolisant is indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy, a chronic neurological disorder that disrupts the brain’s ability to regulate sleep–wake cycles. The drug works as a histamine‑3 (H₃) receptor antagonist/inverse agonist, thereby increasing histamine release in the brain and promoting wakefulness.
According to Lupin, the generic Pitolisant Tablets 4.45 mg and 17.8 mg will be manufactured at the company’s Nagpur manufacturing facility in India, which already supplies multiple products to the U.S. market.
The approval strengthens Lupin’s U.S. generics portfolio, particularly in the central nervous system (CNS) therapeutic segment. Tentative approvals are granted by the U.S. FDA when a generic drug meets all quality, safety, and efficacy requirements but cannot yet be marketed in the United States due to existing patent or exclusivity protections on the reference product.
Wakix® is marketed in the United States by Harmony Biosciences, a U.S.‑based biopharmaceutical company. The drug has become an important treatment option for narcolepsy‑related excessive daytime sleepiness and cataplexy, and generic competition is expected to expand patient access once relevant intellectual property protections expire.
With this tentative approval, Lupin Limited moves closer to launching a lower‑cost generic alternative in the U.S. market following the expiry of applicable patents and exclusivities related to Wakix®.
References
Lupin Receives Tentative Approval from U.S. FDA for Pitolisant Tablets, 25 March 2026, https://www.lupin.com/media/press-releases/lupin-receives-tentative-approval-from-u-s-fda-for-pitolisant-tablets
