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Generic Rx Zegerid deals blow to Santarus

This article was originally published in The Tan Sheet

Executive Summary

The proton pump inhibitor's originator is reducing its workforce by 37 percent, or about 120 employees, and ceasing promotion of Rx Zegerid in light of Prasco Labs' July 1 launch of a generic equivalent. A federal court in April ruled as invalid five patents held by Santarus on Zegerid (omeprazole/sodium bicarbonate), paving the way for generic competition (1"The Tan Sheet" April 19, 2010, In Brief). CEO Gerald Proehl said the layoffs were "an extremely difficult decision" for the San Diego-based firm, which had expected increased prescriptions for Zegerid following Merck/Schering-Plough's April launch of Zegerid OTC (2"The Tan Sheet" Nov. 23, 2009, In Brief). A Santarus spokeswoman said the firm still may receive an additional $37.5 million in Zegerid OTC sales milestones from the licensee

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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

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