Welcome to “A to Z: Drugs in Highlight
This series is designed to delve into the intricate realm of pharmaceutical drugs. As the world of pharmaceuticals continues to evolve with new discoveries and emerging challenges, we aim to shed light on the diverse array of medications available today, ranging from blockbuster medications to those that may not be as familiar. Whether you’re a healthcare professional, a student, or simply someone with a curious mind, “A to Z: Drugs in Highlight” promises to be an enlightening and engaging series.
Q is for QUVIVIQ®
QUVIVIQ® (from Idorsia Pharamceuticals) is a medicine for treating adults with insomnia (difficulty falling asleep or staying asleep).
How it works:
QUVIVIQ® contains the active substance daridorexant. Daridorexant works by targeting the orexin system, which plays a crucial role in regulating the sleep-wake cycle. Specifically, daridorexant is a dual orexin receptor antagonist (DORA). It selectively blocks the binding of orexin A and orexin B neuropeptides to their receptors, OX1R and OX2R. Orexins are wake-promoting neuropeptides. By inhibiting their action, daridorexant helps people fall asleep more quickly, to stay asleep for longer and to improve functioning during the day.
Marketing approval:
QUVIVIQ® is approved for marketing in the United States (approved by the FDA in January 2022) and in Europe (approved by the EMA in April 2022 and by the MHRA in August 2022).
In 2024, QUVIVIQ® generated total product sales of CHF 61 million in the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, France, and Sweden. By the end of 2024, over 550,000 prescriptions had been dispensed in the US alone.
Patent protection:
There are patent rights protecting QUVIVIQ® in the United States and Europe. For example, EP2855453B1, US10329287B2 and US9732075B2 protect the compound daridorexant. In particular, EP2855453B1 relates to a compound of formula (I)
Each of Ar1, R1, R2, R3, R4a, R4b, R5 and n are broadly defined. Daridorexant is specifically protected in claim 13.
Idorsia Pharmaceuticals has been awarded supplementary protection certificates (SPCs) across Europe for “dariodorexant or a pharmaceutically acceptable salt thereof, in particular daridorexant hydrochloride”. See, for example, SPC/GB22/049. These SPCs extend the maximum protection period for dariodorexant until 1 May 2037.
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