Harmony Biosciences (HRMY) Announces Favorable Settlement in ANDA Litigation

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Harmony Biosciences Strengthens Patent Position With Favorable Settlement in ANDA Litigation

June 5, 2025 8:05 AM EDT

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)-- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupins Abbreviated New Drug Application (ANDA) for a generic version of WAKIX® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will be dismissed, and 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 had asserted multiple patents... More