Harmony Biosciences Issues Statement Regarding Confidence in Pitolisant Drug

Harmony Biosciences has reaffirmed its confidence in the strength of WAKIX® (Pitolisant) patents, after receiving a positive ruling from the U.S. Patent and Trademark Office (USPTO) rejecting the request for reexamination. WAKIX® is used to treat excessive daytime sleepiness (EDS) or cataplexy in adults with Narcolepsy. Read Harmony Biosciences' community-facing statement below:

We are pleased that the U.S. Patent and Trademark Office (USPTO) rejected a challenge to the validity of claims within the patent covering the active ingredient in WAKIX® (pitolisant), in line with our expectations. This decision not only underscores our confidence in the strength of the WAKIX patent portfolio but also reinforces our belief in the potential of the WAKIX franchise. We continue to believe that WAKIX represents a billion-dollar plus opportunity in narcolepsy alone, with the potential to contribute up to an additional $1 billion dollars, if approved, in idiopathic hypersomnia and other current lifecycle management programs. We are proud of the work we do every day to address the unmet medical needs of patients living with rare neurological diseases.

(Harmony Biosciences shared this statement in its official press release announcement: 


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