Belsomra, also known by its generic name suvorexant, was first approved by the U.S. Food and Drug Administration (FDA) on August 13, 2014 [1]. This approval marked its official release date in the United States market.
When does Belsomra's patent expire?
The primary patents protecting Belsomra are set to expire at different times. According to DrugPatentWatch.com, the earliest patent expiry for Belsomra is anticipated in 2027 [2]. However, other patents related to the drug may extend further, potentially influencing the market exclusivity timeline.
Can generic versions of Belsomra be released?
The availability of generic versions of Belsomra depends on the expiration of its patents and any associated regulatory exclusivities. Once these protections lapse, and if generic manufacturers successfully navigate the FDA approval process for their Belsomra equivalents, generic versions could become available [2]. This process typically involves demonstrating bioequivalence to the brand-name drug.
What is Belsomra used for?
Belsomra is a prescription medication used to treat insomnia characterized by difficulties with sleep onset and/or sleep maintenance [1]. It belongs to a class of drugs known as orexin receptor antagonists, which work by blocking the action of orexins, wakefulness-promoting chemicals in the brain.