Zegerid could make switch to OTC by year’s end

A Zegerid-branded proton-pump inhibitor might reach drug store shelves by the end of the year after all, following Schering-Plough’s June response to a Food and Drug Administration complete response letter originally issued in January. Santarus, which owns the prescription rights to the PPI, last month announced the FDA’s new action date on the switch application would be this December.

Following the FDA’s initial complete response letter, there was speculation that the Zegerid switch may be in serious jeapordy. That speculation was based on two factors: The FDA had additional questions around the switch application, but the general public really had no inclination as to which direction the FDA was leaning on the matter. That’s because “complete response letters” replaced FDA’s “approvable” and “not approvable” letters. So some analysts assumed the worst.

Should the FDA approve Zegerid for sale OTC, it would mark the second PPI to hit the market this year after Novartis’ Prevacid 24HR in the summer. It also would be the first PPI formulation that combines omeprazole with something else—sodium bicarbonate, an antacid that has afforded Santarus the prescription marketing claim that Zegerid is the “first and only” immediate-release PPI on the market.

It also will mark a very interesting and volatile 2010 for marketers of all heartburn remedies. The antacid tablet category was slightly down 1.3%, according to Information Resources Inc. for the 52 weeks ended April 19 across food, drug and mass (excluding Walmart), for the most part on account of the launch of a store-brand equivalent to Procter & Gamble’s Prilosec OTC.

But now with Novartis and Schering-Plough in the PPI offering mix, the category likely will be significantly up from its present $1.1 billion sales base.