CHESTER, N.J. Adams Respiratory Therapeutics on Thursday announced that it has filed a lawsuit in the United States District Court for the District of New Jersey against Perrigo for patent infringement of its Mucinex line of oral solid, extended-release guaifenesin products. Adams claims that the patents protecting Mucinex don’t expire until 2020.
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, which seeks Food and Drug Administration 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 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 rules in favor of Perrigo.
Adams markets six patent-protected extended-release guaifenesin products over-the-counter under the Mucinex brand name, including a new line of 1,200 mg maximum-strength products. These products are the only available FDA-approved extended-release guaifenesin products, the company claimed. Perrigo's ANDA relates only to guaifenesin 600 mg single-ingredient, extended-release tablets.