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ALLEGAN, Mich. — The battle is on for a storebrand version of Prilosec OTC, as Dexcel Pharma Technologies filed for a new drug application to market omeprazole over-the-counter and was sued immediately by AstraZeneca for patent infringement.
Earlier this month, Perrigo joined the fray as it announced a deal with Dexcel in which Perrigo will distribute and market a private-label version of Prilosec. Under terms of an agreement between the two companies, Perrigo Co. will be the exclusive marketer and distributor of the Dexcel Pharma Technologies-developed and produced product in the United States.
At stake is some share of the $318.4 million Prilosec OTC generated in sales in food, drug and mass outlets (excluding Wal-Mart) during the most recent one-year period, ended May 21, according to Information Resources Inc.
Procter & Gamble, which had negotiated the marketing rights for Prilosec OTC from AstraZeneca three years ago, stated that patents protecting Prilosec extend well beyond the three-year marketing exclusivity they earned with the switch of the proton pump inhibitor in 2003. According to Orange Book data, a listing of drug information on the Food and Drug Administration web site, there are patents protecting Prilosec OTC at least through April 2007 and possibly through November 2019 if Dexcel’s patent challenge proves futile.
“After expiration of FDA-granted marketing exclusivity, Prilosec OTC will remain protected by the patents listed in the FDA Orange Book,” explained P&G spokesman Steve Sholtes. “We remain confident in the patent protection. Therefore, generic competition is neither certain nor imminent.”
Currently, five generics 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 an OTC version of the drug, but when P&G’s exclusivity expires, it is expected that vendors are expected to line up to file applications with FDA.
The introduction of a store-brand equivalent to Prilosec OTC will help lift private label penetration in antacids tablets, which for the 52 weeks ended May 21 fell 4.8 percent to $120.4 million across food, drug and mass (minus Wal-Mart), according to IRI, representing just over 12 percent of the total antacid market–just about average for private label penetration in any given OTC category.
As for P&G’s plans this year for Prilosec OTC, aside from rooting on AstraZeneca in its patent-infringement case against Dexcel, the company plans to continue, to leverage its points of difference aggresively against other OTC stomach aids.
“We have worked really hard in the last year to drive home the message that with Prilosec OTC, it’s possible to live life to the fullest without having to think about frequent heartburn,” Crystal Harrell, Prilosec OTC brand manager, told Drug Store News. The message behind the brand’s recent ad campaign, launched in August 2005, “The Days Campaign,” is simple: “A day with Prilosec OTC is another day farther from frequent heartburn,” Harrell said.
P&G has spent more than $50 million on national advertising for Prilosec OTC in the past year, according to published reports.
Also due for store brand competition is Johnson & Johnson/Merck’s Maximum Strength Pepcid AC, suggesting that store brand equivalents in the heartburn segment will help fuel another year of growth for private label in drug stores.
According to the Private Label Manufacturers Association, store brands accounted for about one-fifth of all the new dollars and unit sales that were generated in the channel overall in 2005. Drug store operators enjoyed a dollar share penetration of 12 percent across private label, up 30 basis points, reaching an historic level.
MICHAEL JOHNSEN
CATEGORY SPECIALIST
Top 10 OTC antacid brands/tablets

$ sales % change
in millions vs year ago

Antacid tablets $981.0 7.7%
Prilosec OTC 318.4 27.5
Private label 120.4 -4.8
Pepcid AC 75.3 -9.9
Zantac 150 57.1 271.8
Turns EX 55.1 -4.3
Pepcid Complete 47.9 -1.8
Rolaids 40.9 0.1
GasX 39.4 -0.8
Zantac 75 36.3 -40.6
Tums Ultra 28.6 13.6

Source: Information Resources Inc., food/drug/mass
(excluding Wal-Mart) for the 52 weeks ended May 21

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