Perrigo files NDA with FDA for generic Zegerid OTC

Perrigo Company (Nasdaq: PRGO; TASE) announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for omeprazole 20mg/sodium bicarbonate 1100mg, the generic equivalent of Zegerid OTC™, and that it provided prior notice of this filing to Schering-Plough HealthCare Products, Inc. a subsidiary of Merck & Co., Inc., the owner of the brand regulatory approval and the Curators of the University of Missouri, the listed patent owner.

On September 20, 2010, Schering-Plough filed suit alleging patent infringement in the United States District Court of New Jersey to prevent Perrigo from proceeding with the commercialization of this product. This action formally initiates the process under the Hatch-Waxman Act. In addition, Santarus, Inc. 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 U.S. 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. An appeal of that decision was filed in May 2010, and the appeal is pending.

The Perrigo product is generic equivalent to Schering-Plough's Zegerid-OTC™ (omeprazole 20 mg/sodium bicarbonate 1100mg) a proton pump inhibitor and antacid indicated for the treatment of frequent heartburn. Sales for the OTC brand are estimated to be approximately $60 million annualized from the most recent month, according to IRI.  

Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is an example of our focus on bringing new Rx to OTC switch products to market. It is a great addition to our diverse offering of gastrointestinal products."  

Source:

Perrigo

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