Harmony Biosciences (HRMY) announced a settlement agreement with Lupin Limited, resolving patent infringement litigation related to Lupin’s Abbreviated New Drug Application for a generic version of WAKIX. Under the agreement, 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. Harmony asserted multiple patents covering WAKIX, its FDA-approved treatment for excessive daytime sleepiness or cataplexy in adults and pediatric patients with narcolepsy.
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