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# Prepopik Settlement Can Cause ANDA Problems: Attorney
- URL: https://www.fdaweb.com/prepopik-settlement-can-cause-anda-problems-attorney/
- Published: 2017-03-28T12:00:00.000Z
- Updated: 2026-09-14T22:14:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138309

Attorney **Kurt Karst** says that an apparent settlement between FDA and Ferring Pharmaceuticals over five-year new chemical entity (NCE) exclusivity for Ferring’s colonoscopy prep Prepopik (sodium picosulfate, magnesium oxide, and citric acid) for oral solution is likely to cause problems for the agency’s Office of Generic Drugs (OGD) and affected ANDA applicants who have been in line for several years. Writing in his firm’s *FDA Law Blog*, Kurst [says](Down%20the%20Tubes:%20FDA%20Settles%20PREPOPIK%20NCE%20Exclusivity%20Dispute;%20ANDA%20Submissions%20in%20Unsettled%20State) the agency and Ferring apparently reached a quiet settlement that most likely granted Ferring five-year exclusivity for its fixed-dose combination drug that contains both a new chemical entity and a previously approved drug.

The settlement came after Ferring submitted to a D.C. federal court examples that “demonstrate that a single-entity drug substance’s ability to receive five-year exclusivity can turn arbitrarily on the order in which NDAs including that drug substance are approved.” Those precedents would have allowed the court to determine that FDA’s pre-10/2014 interpretation of NCE exclusivity, as applied to Prepopik, was arbitrary and capricious and violated the Administrative Procedures Act, Karst writes.

The blog post speculates that if Ferring receives its NCE exclusivity, it seems likely that any other similarly situated NDA holder will also be awarded NCE exclusivity, such as Gilead for Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir, disproxil fumarate) tablets.

“But resetting the exclusivity periods for Prepopik, Stribild, and other drug products is going to cause OGD and affected ANDA applicants some big headaches,” he says. “Affected ANDA applicants will likely receive correspondence from OGD providing guidance on the path forward in light of FDA’s decision to recognize NCE exclusivity for affected fixed-dose combination drug products. Presumably, ANDAs will need to be withdrawn and resubmitted to FDA. But will it be a race to resubmission for ANDA paragraph 4 applicants to secure first applicant status (and thus eligibility for 180-day exclusivity)? Or will FDA backdate ANDA submissions to the so-called NCE-1 dates … so that previous first-filers don’t lose their place in line? We’ll see.”