Pfizer Expects OTC Nexium Will Launch With Market Exclusivity

29 Mar 2014

Marketing exclusivity would be a key advantage as Nexium 24HR enters a crowded market of branded and private label OTC competitors. The NDA for Nexium 24HR included clinical data, Pfizer says, but whether FDA allowed Hatch-Waxman Act exclusivity for the product is not yet determined.

Pfizer Inc. expects to launch OTC proton pump inhibitor Nexium 24HR with three-year market exclusivity, following FDA’s approval on March 28 of a new drug application for the 20 mg esomeprazole product.

Nexium 24HR is indicated for frequent heartburn, defined as happening two or more days a week, in consumers age 18...