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# Gilead Seeks NCE Exclusivity for Stribild
- URL: https://www.fdaweb.com/gilead-seeks-nce-exclusivity-for-stribild/
- Published: 2016-10-18T12:00:00.000Z
- Updated: 2026-09-14T21:40:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137101

Gilead says that under the terms of a recent federal court decision, FDA should grant its Stribild (cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarate) five-year new chemical entity (NCE) exclusivity and should extend that exclusivity to all subsequently approved drug products containing any of the new active moieties (elvitegravir and cobicistat) approved in Stribild. The petition says that FDA denied Gilead NCE exclusivity for its fixed-combination Stribild based on a since-revised policy that a fixed-combination product containing both previously approved and new active moieties is not eligible for such exclusivity.

“FDA revised this NCE policy in 2/2014 in response to, in part, a citizen petition filed by Gilead,” this [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-3312-0001&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) says, “but nonetheless refused to apply its new policy to Stribild and other similarly-situated fixed combination drug products.”

The DC federal court recently held that the agency’s pre-2/2014 policy was arbitrary and capricious and remanded the exclusivity determination for the fixed-combination product Prepopik back to FDA for further review, the petition says. “In light of this decision, Gilead requests that FDA review and revise its NCE exclusivity denial for Stribild…,” the petition says. “Gilead also requests that FDA extend, under its umbrella policy, such five-year NCE exclusivity to the subsequently-approved products that contain the new active moieties in Stribild, Tybost and Viteka. Finally, in accordance with these NCE exclusivity determinations, Gilead also requests that FDA withdraw the receipt of any ANDAs referencing these products prior to the expiration of their NCE exclusivity periods.”