Cephalon, Inc. announced that the US Food and Drug Administration (FDA) will apply an additional six months of market exclusivity to Provigil (modafinil) tablets [C-IV]. The extension attaches to the US patent covering Provigil, such that the associated exclusivity now extends until April 6, 2015.

Specifically, the FDA has confirmed that Cephalon met the terms of a written request to provide data from clinical studies examining the effect of Provigil in paediatric patients. The Food and Drug Administration Modernization Act of 1997 enables the FDA to issue written requests for paediatric studies to companies if the agency determines that information related to the use of an approved drug in paediatric patients may produce health benefits, stated the release.

Cephalon previously announced its settlement with four generic firms of its patent infringement litigation concerning Provigil. Under the terms of the settlements, Cephalon granted to each of the four defendants a non-exclusive royalty-bearing right to market and sell a generic version of Provigil in the United States, that will now become effective in April 2012 (subject to earlier entry in certain circumstances).

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction.