India Pharma Outlook Team | Monday, 30 March 2026
Lupin Limited has received a USFDA tentative approval for daytime sleepiness drug, strengthening its position in the US generics market.
The approval covers its generic version of pitolisant tablets, a daytime sleepiness drug used to treat excessive daytime sleepiness in adults with narcolepsy.
The company said the approval is for pitolisant tablets in strengths of 4.45 mg and 17.8 mg. While the product meets all regulatory requirements for safety, quality, and efficacy, it cannot yet be commercially launched in the US due to existing patent protections tied to the reference listed drug.
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Pitolisant works by targeting histamine receptors in the brain, helping regulate the sleep-wake cycle. It is considered an important treatment option for narcolepsy patients dealing with persistent daytime drowsiness. The drug is a generic version of the branded product Wakix, which currently holds market exclusivity.
Lupin confirmed that the product will be manufactured at its Nagpur facility in India. The development highlights the company’s focus on building a strong pipeline in complex generics and central nervous system therapies.
The USFDA tentative approval for excessive daytime sleepiness drug also positions Lupin to enter a niche but growing market once patent barriers are lifted. The move is expected to improve access to more affordable treatment options for patients in the US.
With this approval, Lupin continues to strengthen its presence in the competitive US pharmaceutical market while expanding its portfolio in specialized therapeutic segments.
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