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news.Perrigo has filed an abbreviated new drug application (ANDA) for Omeprazole 20mg/sodium bicarbonate 1100mg, the generic equivalent of Zegerid OTC, with the US Food and Drug Administration (FDA).
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The Perrigo product is a proton pump inhibitor and antacid indicated for the treatment of frequent heartburn.
Perrigo has also provided prior notice of this filing to Schering-Plough HealthCare Products, a subsidiary of Merck, the owner of the brand regulatory approval and the Curators of the University of Missouri, the listed patent owner.
Schering-Plough filed suit against Perrigo alleging patent infringement in the US District Court of New Jersey on 20 September 2010.
In addition, Santarus and the Curators of the University of Missouri, licensor and owner of the patents, were joined in the lawsuits as co-plaintiffs.
In connection with litigation relating to Zegerid brand prescription products, the US District Court for the District of Delaware ruled in April 2010 that the same patents that are the subject of the present action were invalid due to obviousness.
Perrigo chairman and CEO Joseph Papa said that the product is an addition to their offering of gastrointestinal products.