Despite Prilosec OTC Weakness, P&G Grows With Price Hikes, Cost Cuts
This article was originally published in The Tan Sheet
Executive Summary
Procter & Gamble's Prilosec OTC business felt the heat of private-label competition during the firm's latest quarter, the first full period since the brand lost market exclusivity as an OTC proton pump inhibitor
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Prilosec OTC loses patent extension
The U.S. Patent and Trademark Office dismisses AstraZeneca's application to extend a key product patent for the OTC proton pump inhibitor it licenses to Procter & Gamble. The agency explains in a Dec. 16 letter that Prilosec OTC is ineligible for a patent term extension because it was not the first instance of commercial marketing for the underlying active ingredient and because its application was submitted in an untimely fashion. The Prilosec OTC patent expires Oct. 6, 2015, according to FDA's Orange Book of approved drug products. An AstraZeneca spokesman says the firm is "disappointed" in PTO's denial, but "we remain confident in our intellectual property." Attorney Kurt R. Karst of Hyman, Phelps & McNamara, writes in the FDA Law Blog Jan. 4 that AstraZeneca will likely contest PTO's decision in court. He adds in a Jan. 7 interview that the denial "could mean earlier generics" in the PPI market "but we don't know at this point." Private-label OTC PPIs emerged in 2008 after Prilosec OTC lost market exclusivity (1"The Tan Sheet" Aug. 11, 2008, p. 3)
Schering-Plough’s Zegerid Switch Stumbles As FDA Questions Application
FDA indicated to Schering-Plough that the firm's Rx-to-OTC switch application for the proton pump inhibitor Zegerid is not ready for approval
Prilosec OTC loses patent extension
The U.S. Patent and Trademark Office dismisses AstraZeneca's application to extend a key product patent for the OTC proton pump inhibitor it licenses to Procter & Gamble. The agency explains in a Dec. 16 letter that Prilosec OTC is ineligible for a patent term extension because it was not the first instance of commercial marketing for the underlying active ingredient and because its application was submitted in an untimely fashion. The Prilosec OTC patent expires Oct. 6, 2015, according to FDA's Orange Book of approved drug products. An AstraZeneca spokesman says the firm is "disappointed" in PTO's denial, but "we remain confident in our intellectual property." Attorney Kurt R. Karst of Hyman, Phelps & McNamara, writes in the FDA Law Blog Jan. 4 that AstraZeneca will likely contest PTO's decision in court. He adds in a Jan. 7 interview that the denial "could mean earlier generics" in the PPI market "but we don't know at this point." Private-label OTC PPIs emerged in 2008 after Prilosec OTC lost market exclusivity (1"The Tan Sheet" Aug. 11, 2008, p. 3)