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# Gilead Wants NCE Exclusivity for Stribild, 2 Others
- URL: https://www.fdaweb.com/gilead-wants-nce-exclusivity-for-stribild-2-others/
- Published: 2017-03-02T12:00:00.000Z
- Updated: 2026-09-14T22:09:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138110

Gilead is asking FDA for five-year new chemical entity (NCE) exclusivity for its Stribild (cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate) and for that exclusivity to be applied to all subsequently approved drug products (Tybost and Vitekta) that contain any of the new active moieties (elvitegravir and cobicistat) approved in Stribild. The firm’s [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-1278-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says agency action is needed in light of a court decision in *Ferring v. Burrell* that found that FDA’s NCE policy for fixed combination products was arbitrary and capricious. It says Gilead was denied NCE exclusivity for Stribild based on the agency’s since-revised policy that a fixed combination product containing both previously approved and new active moieties is not eligible for such exclusivity.

The petition says that the court’s ruling was unambiguous in holding that the agency’s temporally-based NCE policy was arbitrary and capricious. And the court was clear that FDA provided no sound explanation as to why the timing of or the order in which drugs were approved should alter the assessment of whether the active moiety is sufficiently novel to warrant five-year exclusivity. Gilead contends that since the court told FDA to revise its policy for the product that was involved in the decision and all similarly situated fixed combination drug products for which NCE exclusivity had been denied, it must grant exclusivity to Stribild.

The petition also says that because the three Gilead products should have been protected against receipt of an ANDA before 8/27/16, FDA should withdraw its 1/2016 receipt of a Mylan ANDA referencing Tybost, as well as any other ANDA filed before 8/27/16 referencing a drug containing elvitegravir or cobicistat.