US generic drugmaker Watson Pharmaceuticals says that the Federal Trade Commission and the State of California have filed a lawsuit in the US District Court for the Central District of California alleging that its 2006 patent lawsuit settlement with Belgian pharmaceutical firm Solvay for AndroGel 1% (testosterone gel) CIII is unlawful.
In 2003, Watson submitted an Abbreviated New Drug Application seeking approval to market a generic version of Solvay's testosterone replacement product. The Belgian firm initiated litigation alleging that Watson's product infringed its patent.
Under the terms of a 2006 settlement deal, Solvay granted Watson a non-exclusive license to the US patents covering AndroGel and in return, the local firm agreed not to commence marketing its generic equivalent product until August 31, 2015 or until another generic product enters the US market.
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