PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) recently announced the resolution of its patent litigation against Lupin Limited regarding a generic version of WAKIX® (pitolisant hydrochloride). The settlement agreement, which ends litigation in the United States District Court for the District of Delaware, grants Lupin a license to launch its generic product no earlier than January 2030 or July 2030 with pediatric exclusivity. Other specific circumstances may allow an earlier launch.
The dispute centered on patents protecting WAKIX®, a distinctive FDA-approved treatment for excessive daytime sleepiness (EDS) and cataplexy in adults with narcolepsy, as well as for EDS in pediatric patients aged six and above. Harmony’s intellectual property portfolio has been reinforced by the settlement, securing the company’s innovations in sleep/wake therapies.
“Resolving this matter reinforces the validity of our robust patent estate, which protects important advancements for patients in need,” Harmony said in a statement.
Harmony has been actively defending its intellectual assets and advancing its proprietary technologies. The company is currently developing next-generation formulations of pitolisant and has filed utility patents to extend exclusivity potentially until 2044. These advancements aim to address unmet needs for individuals living with narcolepsy and other hypersomnolence disorders.
Additionally, Harmony’s patent rights were affirmed in July 2024 when the U.S. Patent Office Patent Trial and Appeal Board rejected, for a second time, an Ex Parte Reexamination of the company’s polymorph patent for pitolisant hydrochloride. This decision highlights the strength of Harmony’s patent protections.
The company remains resolute in its commitment to protecting its intellectual property. Harmony continues to litigate against other companies that have filed Abbreviated New Drug Applications (ANDAs) in pursuit of generic versions of WAKIX®.
By ensuring the defense of its patents and exploring new formulations of its therapies, Harmony is positioned to continue delivering innovative treatments to patients facing sleep-related disorders.
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