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# Regulatory Review Period for Intercept’s Ocaliva
- URL: https://www.fdaweb.com/regulatory-review-period-for-intercepts-ocaliva/
- Published: 2018-12-04T12:00:00.000Z
- Updated: 2026-09-15T00:48:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142952

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Intercept Pharmaceuticals’ Ocaliva (obeticholic acid), indicated for treating primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. The regulatory review period was determined to be 3,742 days, including 3,408 days that occurred during the testing phase and 334 days during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-12-04/pdf/2018-26288.pdf?ref=fdaweb.com).