A settlement agreement granting United Research Labs/Mutual Pharmaceuticals a conditional license for certain guaifenesin products could help Adams Respiratory Therapeutics fend off other potential generic competition for its Mucinex brand.

Mutual admits the validity and enforceability of Adams' patent for single-ingredient, extended-release guaifenesin, according to the settlement announced March 21. Mutual also admits that "certain single-agent and combination generic extended-release guaifenesin-based products" infringe on Adams' patent, under the agreement.

"We believe that this settlement agreement not only reinforces the strength of our patent portfolio protecting our oral solid, extended-release guaifenesin products, but it also eliminates the uncertainty around this situation and our ability to drive meaningful growth for these products well into the future," says Adams President and CEO Michael Valentino.

The agreement settles patent infringement suits filed by Adams against Mutual in October in the U.S. District Court of New Jersey and the Eastern District of Pennsylvania (¹ Also see "Adams’ Suit Could Delay ANDA For URL/Mutual’s Mucinex Generic" - Pink Sheet, 9 October, 2006., p. 9).

The suits were filed in response to Mutual's abbreviated new drug application for a generic version of the extended-release Mucinex product, announced in August 2006 (² 'The Tan Sheet' Aug. 21, 2006, In Brief).

The patent at issue covers Adams' extended-release bi-layer delivery system for single-ingredient and combination products, and is set to expire in 2020.

Under the settlement, Adams grants Mutual a non-exclusive, royalty-free license for U.S. sale of single-ingredient licensed guaifenesin products beginning July 1, 2012, excluding certain circumstances.

If another firm successfully challenges Adams' patents and gains FDA approval prior to that date, Mutual may begin selling generic Mucinex 60 days before the third party's product launch; if Mutual does not have FDA approval at that time, the firm can also enter into a supply agreement with Adams wherein Mutual would buy tablets at full cost plus 10 percent royalty, Adams states.

- Jessica Lake (j.lake@elsevier.com)

Adams Reinforces Mucinex Patents In Settlement Agreement With Mutual

More from Archive

More from Pink Sheet