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# Regulatory Review Period for Sunosi
- URL: https://www.fdaweb.com/regulatory-review-period-for-sunosi/
- Published: 2021-11-18T12:00:00.000Z
- Updated: 2026-09-14T17:22:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150602

*Federal Register* notice: FDA has determined the regulatory review period for patent extension purposes for Jazz Pharmaceuticals’ Sunosi (solriamfetol Hcl), indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. The review period is 8,209 days, which includes 7,664 days that occurred during the testing phase and 545 days during the approval phase. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-25297.pdf?ref=fdaweb.com).