Harmony Biosciences Holdings, Inc., announced a settlement agreement with Lupin for a generic version of WAKIX (pitolisant hydrochloride).

Harmony Biosciences holds the marketing authorisation for pitolisant (WAKIX). WAKIX was designed and developed by Bioprojet in France. Harmony holds an exclusive license from Bioprojet to develop, manufacture, and commercialise pitolisant in the United States. Pitolisant is used to treat excessive daytime sleepiness caused by narcolepsy. It received approval in the U.S. in August 2019. Seven ANDA filers filed on the NCE-1 date in August 2023. Orange Book listed patents

Harmony Biosciences Holdings, Inc., announced a settlement agreement with Lupin on June 5, 2025, resolving the patent infringement litigation related to Lupin’s 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. The court trial is to start in February 2026. 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.

Out of seven First filers on NCE-1 dates, a few others have also settled; for example, Novugen settled in October 2024. Zenera and MSN have received tentative approval and are litigating the case.

US 8207197 claims crystalline pitolisant monohydrochloride. MSN may be using an amorphous API and has filed a patent application WO2023214431 for a composition using the amorphous API.

Lupin is very likely to use pitolisant monohydrate in its ANDA as claimed in OB listed `197, and the case has been settled for a two-month advanced launch before the expiration of the monohydrochloride patent.

Harmony is currently claiming to advance next-generation formulations of pitolisant, with utility patents filed that potentially provide exclusivity until 2044. These formulations are designed to address ongoing unmet medical needs in patients living with narcolepsy and other central disorders of hypersomnolence. I tried to search for this new patent application, but it may not have been published yet. Since the company claims new composition patents will expire in 2044, it could have a priority date in 2024 and will be published soon.





Location: Mumbai, Maharashtra, India

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