Adams Respiratory files lawsuit against Perrigo for infringement of extended-release guaifenesin patent.Adams Respiratory Therapeutics, Inc. (Chester, NJ) has filed a lawsuit in the United States District Court for the District of New Jersey The United States District Court for the District of New Jersey is the Federal district court whose jurisdiction is the state of New Jersey. It was established in 1789. New Jersey is the largest state by population to only have one District Court. The Honorable Garrett E. against Perrigo Company, L. Perrigo Company and Perrigo Research and Development Company (collectively Perrigo), for infringement of Adams' United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. Patent 6,372,252. The '252 patent, which relates to the company's Mucinex line of oral solid, extended-release guaifenesin products, expires in 2020 and is listed in the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Orange Book. Adams filed the lawsuit in response to Perrigo's notification that it filed a Paragraph IV Certification in connection with its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ), which seeks FDA approval to engage in the commercial manufacture, use or sale of guaifenesin 600 mg single-ingredient, extended-release tablets (equivalent to Adams' Mucinex SE), prior to the expiration of the '252 patent. This patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. lawsuit will automatically stay the FDA from approving Perrigo's ANDA until the earlier of 30 months or until a district court decision that is adverse to Adams. Adams markets six patent-protected extended-release guaifenesin products over-the-counter under the Mucinex brand name, including a new line of 1200 mg maximum-strength products. These products are the only available FDA-approved extended-release guaifenesin products. Perrigo's ANDA relates only to guaifenesin 600 mg single-ingredient, extended-release tablets. Adams plans to vigorously defend its market position for Mucinex as well as its patent portfolio protecting the company's oral solid, extended-release guaifenesin products. Adams is a specialty pharmaceutical company focused on the late-stage development, commercialization and marketing of over-the-counter and prescription pharmaceuticals for the treatment of respiratory disorders. Respiratory Therapeutics, Inc. +1-908-879-2428 www.adamsrt.com |
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