Prilosec soon to face store-brand competition

Store-brand versions of Prilosec OTC are expected to reach drug store shelves as early as June of this year--marking the expiration of Procter & Gamble s three-year exclusivity of the popular over-the-counter proton-pump inhibitor.

Currently, five generic companies, including Mylan, have approval to market generic omeprazole as a prescription treatment for heartburn and GERD. No private label company has yet received FDA approval to market a store-brand omeprazole for the treatment of frequent heartburn, but when the P&G exclusivity expires, private label companies are expected to file for approval to market their versions of omeprazole over the counter.

In comparison, as many as seven private label suppliers, as well as Wyeth, have been approved to market another chronic over-the-counter medicine, loratadine. The market for a store-brand Prilosec OTC is expected to be at least as competitive.

The introduction of a store-brand equivalent to Prilosec OTC will help lift private label penetration in antacids, which for the 52 weeks ended Dec. 31 fell 3 percent to $143.8 million across food, drug and mass (minus WalMart), according to ACNielsen, representing a 12.6 percent share of the overall antacid market.

As for other competitive threats to Prilosec OTC, it will be another three years before a second proton-pump inhibitor is introduced to the market. Novartis late last year acquired the rights to market an OTC version of Tap Pharmaceutical's Prevacid when that drug's patent expires in 2009.
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Sales of Prevacid as a prescription-only heartburn and GERD remedy fell 2 percent in 2005 to $3.8 billion, according to pharmaceutical market research firm IMS Health.

"Our goal is to switch Prevacid upon its patent expiration and make it one of the top five OTC products in the United States, noted Larry Allgaier, chief executive officer of Novartis Consumer Health, OTC. "We have the experience and a proven track record in switching drugs from Rx to OTC. We're excited about making Prevacid a brand that people know and trust--even more accessible to patients in the future."

MICHAEL JOHNSEN

CATEGORY SPECIALIST

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