The generic version of Belsomra (suvorexant) is anticipated to become available following the expiration of its primary patents. In the United States, Belsomra's main patents are set to expire around December 2027 [1].
When is exclusivity expected to end?
Exclusivity for Belsomra is tied to the expiration of its patents. The initial patent for suvorexant was filed in December 2007, and with extensions, its protection in the U.S. is expected to last until December 2027 [1].
What happens when the patents expire?
Once Belsomra's patents expire, generic manufacturers will be able to produce and market their own versions of suvorexant. This typically leads to a significant decrease in the drug's price due to increased competition [2].
Can biosimilars enter before patent expiry?
Belsomra is a small molecule drug, not a biologic. Therefore, the concept of biosimilars, which applies to biologic drugs, does not apply here. Generic versions are the relevant pathway for market entry after patent expiration [3].
What is the difference between Belsomra and other sleep medications?
Belsomra is a dual orexin receptor antagonist. Unlike older sleep medications such as benzodiazepines or Z-drugs, which broadly suppress the central nervous system, Belsomra works by blocking the wakefulness-promoting neurotransmitter orexin [4]. This mechanism is thought to result in a more targeted approach to sleep regulation [4].
Who makes Belsomra?
Belsomra is manufactured by Merck & Co. [5].
What clinical data supports Belsomra's use?
Clinical trials have demonstrated Belsomra's efficacy in improving sleep onset and sleep maintenance in adults with insomnia characterized by trouble falling asleep and/or staying asleep [4]. Studies have shown statistically significant improvements in sleep latency and wake after sleep onset compared to placebo [4].
What are the risks associated with Belsomra?
Potential side effects of Belsomra include somnolence, dizziness, and headache [4]. Like other sleep medications, it carries a risk of complex sleep behaviors, such as sleepwalking and sleep-driving, which can lead to serious injury or death [4]. Patients are advised to stop taking Belsomra and contact a healthcare provider immediately if they experience these behaviors [4].
How much does Belsomra cost?
The cost of Belsomra can vary. Information on generic drug pricing after patent expiration is typically updated on drug pricing resources like DrugPatentWatch.com [1].
Sources:
1. https://drugpatentwatch.com/
2. "Generic Drug Facts." U.S. Food and Drug Administration, https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
3. "Biosimilar and Interchangeable biologics." U.S. Food and Drug Administration, https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-biologics
4. Belsomra [package insert]. Merck & Co., Inc.; 2023.
5. "Merck & Co., Inc. (MRK)." Yahoo Finance, https://finance.yahoo.com/quote/MRK/