Harmony Biosciences Bolsters Patent Position After Positive ANDA Litigation Settlement

Harmony Biosciences Holdings, Inc., a pharmaceutical firm based in Plymouth Meeting, Pennsylvania, has reached a settlement with Lupin Limited regarding a patent infringement case. This case stemmed from Lupin's application to produce a generic version of Harmony's medication, WAKIX® (pitolisant hydrochloride). As part of the agreement, the litigation in Delaware will be concluded, and Lupin will be permitted to introduce its generic product starting in January 2030, or July 2030 if pediatric exclusivity is considered, unless certain conditions allow for an earlier release.

WAKIX® is notable for being the first non-scheduled treatment approved by the FDA specifically for excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy, and also for EDS in children aged six and above with the same condition. This settlement highlights the robustness of Harmony's patent portfolio, which safeguards its innovations in sleep disorder treatments. Harmony is also working on advanced versions of pitolisant, supported by patents that could extend exclusivity until 2044, to meet ongoing medical needs in treating narcolepsy and other hypersomnolence disorders.

Further affirming Harmony's patent strength, the U.S. Patent Office's Patent Trial and Appeal Board, on July 31, 2024, denied an Ex Parte Reexamination of Harmony's polymorph patent for pitolisant hydrochloride for the second time. This outcome supports the validity and enforceability of Harmony’s patent assets. Harmony continues to defend its intellectual property assertively and is engaged in ongoing litigation against other companies pursuing approval for generic variations of WAKIX®.

WAKIX® (pitolisant) is a pioneering medication in its class, approved in the United States for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, and for EDS in children over six years old with narcolepsy. It received orphan drug designation in 2010 for narcolepsy treatment, followed by breakthrough therapy designation for cataplexy in 2018. WAKIX functions as a selective histamine 3 (H₃) receptor antagonist/inverse agonist. Although the exact mechanism is not fully understood, it is believed to work by increasing histamine levels, promoting wakefulness. Originally developed by Bioprojet in France, Harmony holds exclusive U.S. rights to develop, produce, and market pitolisant.

Concerning safety, WAKIX is contraindicated for individuals with known hypersensitivity to its components and those with severe liver impairment. It can extend the QT interval, necessitating caution in patients with a history of heart rhythm disorders or those taking medications that can prolong the QT interval. Patients with liver or kidney issues should be monitored for increased QTc intervals, with dosage adjustments as needed for those with moderate liver impairment or renal issues.

In clinical trials, WAKIX was generally well tolerated, though some common side effects included insomnia, nausea, and anxiety in adults, with headaches and insomnia more prevalent in pediatric trials. Drug interactions require careful management; strong CYP2D6 inhibitors can increase pitolisant levels, necessitating dosage reductions, while CYP3A4 inducers can decrease its exposure. Patients using hormonal contraceptives should consider alternative methods, as WAKIX may reduce their effectiveness.

Harmony Biosciences, established by Paragon Biosciences in 2017, is focused on developing therapies for rare neurological conditions with unmet needs. Driven by innovative science and a commitment to improving patient lives, Harmony aims to create a future with more therapeutic options.