Zegerid OTC Approved, Limited To Touting Dual-Ingredient Formula For Now
This article was originally published in The Tan Sheet
Executive Summary
Merck's Schering-Plough Consumer HealthCare Products division will launchZegerid OTC in the first half of 2010 as the first dual-ingredient OTC proton pump inhibitor
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In Brief
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Zegerid study finds acid control edge
Merck Consumer Care's proton pump inhibitor Zegerid OTC (omeprazole/sodium bicarbonate) is clinically shown to offer "greater and faster acid control" after seven days of treatment than Prevacid 24HR (lansoprazole), Merck says. However, this does not translate to faster heartburn symptom relief than Novartis' PPI, Merck added in a May 4 release. Despite being the only dual-ingredient OTC PPI on the market, Zegerid OTC does not tout clinical superiority over Prevacid 24HR or Procter & Gamble's Prilosec OTC (omeprazole) (1"The Tan Sheet" Dec. 7, 2009). Merck declined to comment on whether it will use the study results in labeling or marketing
Zegerid patents ruled invalid
A federal court in Delaware finds five patents on Zegerid prescription proton pump inhibitor invalid due to obviousness, likely also removing a hurdle for private label versions of Zegerid OTC (omeprazole/sodium bicarbonate), just launched by Merck/Schering-Plough. Par Pharmaceuticals filed the patent challenge after submitting abbreviated new drug applications to FDA in 2007 for generic Zegerid, the drug's originator Santarus said April 14. According to FDA's Orange Book, Merck has no period of market exclusivity for Zegerid OTC, approved for sale in December 2009 (1"The Tan Sheet" Dec. 7, 2009). A spokesman for Perrigo, which would likely be among the first to pursue a Zegerid OTC generic, said once patents are overcome, ANDA approval will take approximately two years