Gilead seeking five-year exclusivity for combo products

Gilead Sciences Inc. (NASDAQ:GILD) sent a Stribild and for other fixed-dose combinations that have at least one new active moiety. Currently, FDA interprets the Food, Drug & Cosmetic Act (FDCA) and other regulations to mean that fixed-dose combinations products that contain at least one previously approved active moiety are eligible for only three years of exclusivity, even if the combination contains a new active moiety that alone would be eligible for five years of exclusivity. Gilead is asking the agency to recognize five year exclusivity for all new active moieties, whether first approved as a single agent or in a fixed-dose combination with other previously approved active moieties.

Gilead argued that two of Stribild's four components -- elvitegravir and cobicistat -- are new active moieties and thus eligible for five years of exclusivity under FDCA. As a result, Gilead believes Stribild -- a once-daily tablet comprising elvitegravir, cobicistat and Gilead's HIV drug Truvada emtricitabine/tenofovir -- is also eligible for five years of exclusivity. The company requested that Stribild be listed as a new chemical entity (NCE), with an expiration date of Aug. 27, 2017. In October, Gilead said that since its launch in August, sales of the drug were $17.5 million. ...