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# Court Denies Ferring Prepopik Motion
- URL: https://www.fdaweb.com/court-denies-ferring-prepopik-motion/
- Published: 2018-02-20T12:00:00.000Z
- Updated: 2026-09-14T23:23:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140797

The DC federal court has [denied](https://ecf.dcd.uscourts.gov/cgi-bin/show%5Fpublic%5Fdoc?2015cv0802-69&ref=fdaweb.com) a Ferring Pharmaceuticals motion asking the court to enforce an earlier grant of summary judgment to Ferring that remanded to FDA the case of Ferring’s request for five-year exclusivity for its Prepopik colonoscopy preparation solution. The case revolves around a shifting determination of the chemical classification of a molecule in one of Prepopik’s active ingredients.

After FDA changed its classification determination and in the process denied Ferring the requested exclusivity, the company went back to the court claiming that the agency had not followed the court’s remand instructions to conduct proceedings in accordance with its approval of summary judgment for Ferring.

FDA argued that it had reexamined the question of whether picosulfate is the active moiety within sodium picosulfate in Prepopik and had come to a conclusion that the active moiety was actually bis-(p-hydroxyphenyl)-pyridyl-2-methane (BPHM), which is not eligible for new molecular entity exclusivity because it is in several other approved drugs.

The court held that the agency had not acted outside of its instructions because the question of whether picosulfate was the active ingredient had not been adjudicated as it was not needed to determine whether FDA had properly awarded exclusivity.