Gilead asks FDA to expand exclusivity for a key HIV drug

In the latest development in a heated battle between Gilead Sciences and the US Food and Drug Administration, the company petitioned the agency this month to retroactively grant five years of exclusive marketing for an HIV medicine. And the drug maker argues that it otherwise faces lost sales and added expense from fending off a pending generic threat to its Stribild medication.

The move follows a complicated legal battle in which Gilead challenged an FDA policy toward so-called fixed-dose combination drugs, which consist of two or more chemical entities. At stake are untold amounts of revenue as Gilead and other drug makers have battled the agency over its policy, which a federal judge recently ruled is  “arbitrary and capricious.”

Here’s the background: Until October 2014, the FDA would only grant five years of valuable marketing exclusivity if all of the drugs in a combination medicine were new chemical entities. In other words, these would have been drugs that were not previously approved for any use. A fixed-dose combination containing one older drug would have been eligible for just three years of exclusivity instead.

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