FDA accepts ANDA for Par's generic Focalin

The US Food and Drug Administration has accepted an Abbreviated New Drug Application for a generic version of the attention-deficit hyperactivity disorder drug Focalin XR (dexmethyphenidate HCl). The agent was developed by US drugmaker Par Pharmaceuticals, using proprietary controlled-release drug delivery technology licensed from Canada's IntelliPharmaCeutics (Marketletter August 13).

Earlier this month, Ireland's Elan, US drugmaker Celgene and Switzerland's Novartis filed complaints alleging infringement of certain patents relating to Focalin XR.

In response, IntelliPharmaCeutics said that "law suits such as these are an ordinary and expected part of the process of obtaining approval to commercialize a generic drug." The firm added that it remains confident that its product does not infringe on rights held by the complainant companies, which is a position that it intends to vigorously defend. Under the terms of IntelliPharmaCeutics and Par's agreement, the latter has assumed responsibility for all litigation costs that arise.