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See the DrugPatentWatch profile for Sunosi
When Will Sunosi Go Generic? Sunosi is a prescription medication used to treat excessive daytime sleepiness (EDS) in adults with narcolepsy, who have been treated with standard doses of wakefulness-promoting agents like modafinil. Developed by Sunovion Pharmaceuticals, Sunosi received FDA approval in 2019 [1]. As Sunosi is a branded medication, the question is when it will become available as a generic. Patent information is crucial in determining the timeline. Sunosi Patent Details According to DrugPatentWatch.com, a patent for the active ingredient solriamfetol, which is the key component of Sunosi, was filed by Cephalon, Inc. in 2013. This patent is listed as "Pharmaceutical compositions comprising amfetamines." [2] It expired in August 2022. However, a separate patent filed by Sunovion in 2019 for "Methods for treating excessive daytime sleepiness (EDS) in sleep-disordered breathing syndrome" has not yet expired and is set to expire in 2034. [3] Generic Sunosi Availability Timeline Based on the patent information available, there is a possibility that generic versions of Sunosi could be available as early as 2034, after the expiration of the patent for Solriamfetol or shortly thereafter. However, the actual availability of generic alternatives will depend on several factors, including any further patent or regulatory hurdles and commercial launch decisions by manufacturers. Regulatory Approval and Entry of Competitors The process for gaining FDA approval for a generic version of a brand medication can take several years and includes requirements for demonstrating bioequivalence to the branded medication. As the patent on the Solriamfetol expires, competitors may file an Abbreviated New Drug Application (ANDA) with the FDA to gain approval for their version of the medication. Sources: [1] Sunovion Pharmaceuticals. (2017). SUNOSI (Solriamfetol) Tablets, for Oral Use. Retrieved from https://www.sunovion.com/files/SUNOSI%20US%20PI%20312019.pdf [2] Cephalon. (2013). Pharmaceutical Composition Compaining Amfatamines. Retrieved from https://drugs.patentwatch.com/patent/patentid/CN-201310111551/X [3] Sunovion Pharmaceuticals. (2019). Methods for Treating Excessive Daytime Sleepiness (EDS) in Sleep-Disordered Breathing Syndrome. Retrieved from https://www.drugs.watch/patent/patentid/US10241435B2/