CHESTER, N.J., Sept. 27 /PRNewswire-FirstCall/ -- Adams Respiratory Therapeutics, Inc. today announced that it has filed a lawsuit in the United States District Court for the District of New Jersey against Perrigo Company, L. Perrigo Company and Perrigo Research and Development Company (collectively Perrigo), for infringement of Adams' U.S. Patent No. 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 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 (ANDA), 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 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.
About Adams Respiratory Therapeutics, Inc.
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.
This press release contains certain "forward-looking" statements, including the imposition of an FDA stay on approving the Perrigo ANDA and Adams' defense of its exclusive market position for single-entity Mucinex(R) and its patent portfolio. Such forward-looking statements can be identified by the words "will," "plans" and similar expressions and are subject to risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Factors that could cause actual results to differ materially include, among others, the FDA's failure to apply the same rigorous scientific standards to generic applicants as applied to the FDA approval of Mucinex(R) and Adams' ability to successfully defend its patent position and protect its trade secrets and other proprietary information; and other risk factors set forth under the and other risk factors set forth under Item 1A. Risk Factors in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2007. Except to the extent required by applicable securities laws, Adams is not under any obligation to (and expressly disclaims any such obligation to) update its forward-looking statements, whether as a result of new information, future events, or otherwise. All statements contained in this press release are made only as of the date of this press release.
Adams Respiratory Therapeutics, Inc.