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# Regulatory Review Period for Regeneron’s Dupixent
- URL: https://www.fdaweb.com/regulatory-review-period-for-regenerons-dupixent/
- Published: 2018-10-19T12:00:00.000Z
- Updated: 2026-09-15T00:39:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142628

*Federal Register* notice: FDA has determined for patent extension-related purposes the regulatory review period for Regeneron Pharmaceuticals’ Dupixent (dupilumab), indicated for treating adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The review period is 2,728 days, including 2,485 days that occurred during the testing phase and 243 days during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-17/pdf/2018-22566.pdf?ref=fdaweb.com).