Gilead Sciences Petitions FDA to Request Five-Year Exclusivity for HIV Drug Stribild

Gilead Sciences Inc. has asked the Food and Drug Administration to grant five years of exclusivity to Stribild, a once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.

Stribild, which FDA approved in August 2012 (10 PLIR 1162, 9/7/12), combines four compounds in one daily tablet: elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate.

In its citizen petition to FDA, Gilead said two of the four compounds, elvitegravir and cobicistat, have not been approved by the agency in any other new drug application. The petition, dated Jan. 8, requests five-year exclusivity ...