Lupin Secures FDA Approval For Pitolisant Tablets, Generic Of WAKIX; Expects Launch In 2030

(RTTNews) - Lupin Ltd. (LUPIN) on Monday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, 4.45 mg and 17.8 mg, as bioequivalent to Harmony Biosciences Holdings, Inc.'s (HRMY) WAKIX's approved narcolepsy indications.

WAKIX is approved for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy, and for the treatment of excessive daytime sleepiness and cataplexy in pediatric patients aged 6 years and older with narcolepsy.

Narcolepsy is a neurological disease of sleep-wake state instability characterised by excessive daytime sleepiness (EDS), with or without cataplexy. EDS is the inability to stay awake and alert during the day.

Lupin specialises in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

According to the settlement agreement between Harmony Biosciences and LUPIN, made in June 2025 to resolve patent infringement litigation, LUPIN will receive a license to launch its generic product no earlier than January 2030 or July 2030, with pediatric exclusivity, or earlier under certain circumstances.

For the full year 2025, Harmony Biosciences' Narcolpesy drug WAKIX's net revenue increased to $868.45 million from $714.73 million in the prior year.

Looking ahead to full-year 2026, Harmony Biosciences expects WAKIX net revenue to be in the range of $1.0-$1.04 billion, placing it on track to achieve blockbuster status.

The current FDA approval of Pitolisant Tablet reflects a future generic opportunity for Lupin.

LUPIN.NS has traded between 1,875 Indian Rupees and 2,529.50 Indian Rupees over the last year.The stock closed Monday's trade at 2,259 Rupees.

LUPIN.NS is currently down 1.01% at 2,236.30 Rupees.

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