Harmony Biosciences obtains favorable settlement in litigation over generic Wakix
Harmony Biosciences Holdings announced a settlement agreement with Lupin, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application 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 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 six years of age and older with narcolepsy.
[Read more: AAM report: Generic, biosimilar drugs generate $408B in savings]
This settlement reinforces the validity and strength of Harmony’s intellectual property portfolio, which continues to protect its innovations in sleep/wake therapeutics, the company said.
Harmony is advancing next-generation formulations of pitolisant with utility patents filed with potential exclusivity to 2044.
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, the company said.
Harmony said it 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.
[Read more: What do consumers really think about generics?]