Auxilium Pharmaceuticals and FCB have filed a patent infringement lawsuit, related to Testim 1% testosterone gel, against Watson Laboratories, Watson Pharmaceuticals, and Watson Pharma.
The lawsuit was filed in the US District Court for the District of New Jersey in response to a notice letter sent by Watson Laboratories regarding ANDA filing for the generic product with the FDA.
The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the Watson's notice letter was received or final resolution of the pending patent infringement lawsuit.
Watson would not be permitted to launch its generic product in the US, till it receives tentative approval from the FDA for its generic version of Testim before one of the events occurs.
Until Watson receives the necessary final approval of its ANDA from the FDA, it will also not be able to launch a generic version of Testim in the US.
