ALLEGAN, Mich., Sept. 24 /PRNewswire-FirstCall/ -- 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."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients (API) and pharmaceutical and medical diagnostic products. The Company is the world's largest store brand manufacturer of OTC pharmaceutical products and infant formulas. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).
Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 26, 2010, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.