Adams faces possible generic Mucinex fight

By Elaine Rigoli

Tampa, Fla., Aug. 18 - Adams Respiratory Therapeutics, Inc. said it has been contacted by a company claiming to have submitted an abbreviated New Drug Application to the Food and Drug Administration for a single-ingredient extended-release formulation of guaifenesin (Mucinex).

Adams said this company also claims that their application has been "accepted for filing," which means the FDA review process can begin.

Adams has not yet been notified by the applicant of its Paragraph IV Certification, which is a requirement of the FDA filing, according to a company news release.

Adams said Mucinex is the only FDA-approved, extended-release, single-ingredient guaifenesin product and notes the following two hurdles for a competitor to enter the over-the-counter market:

• The New Drug Application approval of Mucinex was based on rigorous scientific criteria. Adams said it will urge the FDA to apply these same scientific standards to this ANDA filing as it applied to the company's NDA filing for Mucinex.

• The company has two patents that protect its suite of extended-release bi-layer tablet products. These patents are listed in the FDA Orange Book and expire in 2020.

"Based on what we have been told about this ANDA filing, it appears that this product application employs an older, well-known matrix technology. In fact, Adams spent several years working with this technology, but the FDA did not accept the resulting drug release profile and required a higher scientific standard for product approval. We subsequently abandoned this technology and developed our own proprietary bi-layer extended-release formulation, which ultimately served as the basis of our FDA approval for Mucinex," president and chief executive officer Michael J. Valentino said in the release.

"It is our view that this applicant should be held to the same set of rigorous standards that were required of Adams."

Adams is a specialty pharmaceutical company based in Chester, N.J.

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