Kremers Urban reaches settlement agreement with ALZA over Concerta patent litigation

Kremers Urban Pharmaceuticals Inc. is pleased to announce that it has reached a settlement dismissing all pending litigation arising from its Abbreviated New Drug Application (ANDA) to market an extended release methylphenidate hydrochloride product, for which Concerta® is the reference listed drug product. The ANDA is currently under review with FDA.

The settlement includes a patent license and covenant, under existing ALZA Corporation patents under which Kremers Urban may commercially launch its methylphenidate ANDA product on July 1, 2012, or earlier under certain circumstances, pending FDA approval.