Adams set to defend guaifenesin position from competitor

Adams Respiratory Therapeutics has been contacted by a company claiming to have submitted an Abbreviated New Drug Application to the US Food and Drug Administration for a single-ingredient extended-release formulation of guaifenesin, which would make it a direct competitor to Adam's currently-marketed Mucinex, a long-acting guaifenesin product indicated to thin bronchial secretions in patients suffering from cough.

The agent is the only FDA-approved, extended-release, single-ingredient guaifenesin product and Adams believes that there are at least two hurdles for this competitor to enter the over-the-counter market. First, Adams' NDA approval of Mucinex was based on rigorous scientific criteria which the firm will urge the FDA to apply to its evaluation of the ANDA. Second, Adams has two patents that protect its suite of extended-release bi-layer tablet products, which expire in 2020.

Michael Valentino, Adams' chief executive, noted that, "based on what we have been told about this ANDA filing, it appears that this product application employs an older, well-known matrix technology." He noted that Adams spent several years working with this technology, but the FDA did not accept its resulting drug release profile and required a higher scientific standard for product approval. "It is our view that this applicant should be held to the same set of rigorous standards that were required of Adams," he added.