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 Lupin’s 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 covering its WAKIX® (pitolisant HCl) product, the first and only non-scheduled FDA-approved treatment for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. This settlement reinforces the validity and strength of Harmony’s intellectual property portfolio, which continues to protect its innovations in sleep/wake therapeutics. Harmony is currently advancing next-generation formulations of pitolisant with utility patents filed with potential exclusivity to 2044, designed to address ongoing unmet medical needs in patients living with narcolepsy and other central disorders of hypersomnolence.
Further underscoring Harmony’s patent strength, on July 31, 2024, the U.S. Patent Office Patent Trial and Appeal Board declined, for the second time, to institute an Ex Parte Reexamination of Harmony’s exclusively licensed polymorph patent for pitolisant hydrochloride. The Board’s decision affirms the validity and enforceability of Harmony’s patent estate.
Harmony remains committed to vigorously defending its intellectual property and will continue litigating its consolidated patent infringement case against several other companies that have filed ANDAs seeking approval for generic versions of WAKIX® (pitolisant hydrochloride).
