Healthcare Industry News: loratadine
News Release - October 10, 2006
GeoPharma Announces Schering-Plough Lawsuit Related to Generic Version of Clarinex(R)LARGO, Fla., Oct. 10 (HSMN NewsFeed) -- GeoPharma, Inc. (Nasdaq: GORX ) today announced that Schering-Plough (NYSE: SGP ), has filed a lawsuit against the Company and its wholly owned subsidiary, Belcher Pharmaceuticals, Inc. in the United States District Court, District of New Jersey (No. 3:06-cv-04715-MLC-TJB), alleging patent infringement related to Belcher's filing for a generic version of Clarinex® Desloratadine 5 mg tablets. On June 21, 2006, Belcher submitted its Abbreviated New Drug Application (ANDA) filing with the U.S. Food and Drug Administration, and included a "Paragraph IV" certification under the Hatch-Waxman Act, certifying that Belcher believes its proposed generic version of Clarinex tablets do not infringe Schering's patents listed in the FDA's "Orange Book" or that the listed patents are invalid or unenforceable. The Hatch-Waxman Act provides for a 180 day period of exclusivity to one or more proposed generic manufacturers that are the first to file an ANDA with a Paragraph IV certification, and prevail in the litigation. Belcher believes that it is among the first to file, but is not able to confirm this. Belcher was one of multiple generic drug companies named as defendants in the action. According to the complaint, the other defendants are alleged to have filed their ANDA's and Paragraph IV certifications on the same day as Belcher, June 21, 2006. Schering Plough markets Clarinex ® for the treatment of seasonal allergic rhinitis, perennial allergic rhinitis, chronic idiopathic urticaria. According to Schering-Plough, U.S. sales of Clarinex for 2005 were $325 million.
About GeoPharma, Inc.
GeoPharma, Inc. is a rapidly growing pharmaceutical company specializing in the manufacturing and distribution of over-the-counter, nutritional, generic drug and functional food products. The company's growth strategy is to capitalize on its manufacturing expertise to develop high-margin generic or novel drugs for niche markets with high barriers to entry. GeoPharma's competitive advantage lies in its ability to circumvent or overcome the challenges in these markets. For more about GeoPharma, Inc., go to our websites at http://www.geopharmainc.com , http://www.onlineihp.com and http://www.hoodiadexl10.com .
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