Adams Respiratory Therapeutics (ARXT) Files Patent Infringement Suit Against Pharmaceutical Holdings Subsidiaries
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Adams Respiratory Therapeutics, Inc. (Nasdaq: ARXT) has filed a lawsuit in the United States District Court for the District of New Jersey against Mutual Pharmaceuticals Co. and United Research Laboratories, Inc., both wholly owned subsidiaries of Pharmaceutical Holdings Corp. for infringement of U.S. Patent No. 6,372,252, issued in April 2002.
The '252 patent, which is listed in the Orange Book with the Food and Drug Administration (FDA) and expires in 2020, relates to Adams' oral solid, extended-release guaifenesin products. Mucinex and its maximum-strength version, marketed under the Humibid brand name, are the only FDA-approved extended-release expectorant products that provide 12-hour relief from chest congestion in one tablet.
The lawsuit is in response to Mutual/URL's notification that it has filed a Paragraph IV Certification in connection with its Abbreviated New Drug Application (ANDA) with the FDA seeking approval to engage in the commercial manufacture, use or sale of guaifenesin extended-release tablets prior to the expiration of the '252 patent. Adams plans to vigorously defend its exclusive market position for single-entity Mucinex and Humibid.
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