After settling with AstraZeneca last month, Dexcel Pharma Technologies has received final FDA approval for generic Prilosec OTC.
The company’s marketing partner Perrigo plans to launch the product early next year.
Perrigo’s announcement came the same day the FDA confirmed there is no evidence of an increased risk of heart problems with Prilosec (omeprazole) or AstraZeneca’s other heartburn drug, Nexium (esomeprazole magnesium) (DID, Dec. 11).
AstraZeneca sued Dexcel in May 2006 after the company submitted an abbreviated new drug application with Paragraph IV certifications for Prilosec OTC (omeprazole magnesium). As part of the settlement, the companies agreed that Dexcel could market its product as soon as it received final approval (DID, Nov. 5). Other terms of the settlement were not disclosed.
Perrigo Chairman and CEO Joseph Papa said the Prilosec OTC launch during the first quarter of 2008 will likely be the largest in the company’s 120-year history.
Prilosec OTC has estimated annual sales of approximately $750 million, according to Perrigo. The company said it expects itsgeneric product to achieve annual sales of $150 million to $200 million.
Perrigo also raised its fiscal 2008 earnings guidance. Generic Prilosec OTC is expected to contribute between 20 cents and 25 cents earnings per share, resulting in earnings of approximately $1.32 to $1.47 per share.
Prilosec OTC, the first OTC proton-pump inhibitor, is a once-a-day, delayed-release tablet formulation that was approved in 2003.
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