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Zegerid patents ruled invalid

This article was originally published in The Tan Sheet

Executive Summary

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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Perrigo's omeprazole and sodium bicarbonate capsules indicated for the treatment of frequent heartburn will bear labeling that has been through several updates since the first PPI became available OTC in 2004.

Private Label Competition For Zegerid OTC Sets Sail With Perrigo Launch

Perrigo's omeprazole and sodium bicarbonate capsules indicated for the treatment of frequent heartburn will bear labeling that has been through several updates since the first PPI became available OTC in 2004.

Perrigo moves forward with generic Zegerid OTC

Perrigo files an abbreviated new drug application for a generic equivalent of the heart burn reliever Zegerid OTC, drawing a patent infringement suit from Schering-Plough HealthCare Products filed Sept. 20 in the U.S. District Court of New Jersey. Perrigo notes a federal court in Delaware ruled earlier this year in a similar suit that the same patents were invalid due to obviousness (1"The Tan Sheet" April 19, 2010). An appeal is pending in the Delaware case, which is related to Zegerid prescription products. Perrigo said in a Sept. 24 release that it notified Schering-Plough prior to filing the ANDA for the omeprazole 20 mg /sodium bicarbonate 1,100 mg drug. The private labeler cites data from Chicago-based IRI Symphony that places sales of Zegerid OTC at about $60 million annualized in the most recent month

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