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FDA Extends Cephalon Drug Exclusivity


Posted on 2006-03-29 12:17:00



Cephalon Inc., a developer of drugs for narcolepsy, Parkinson's and Alzheimer's diseases, among others, on Tuesday said the Food and Drug Administration will add six months of market exclusivity to its Provigil drug.

The extension attaches to the U.S. patent covering Provigil, and exclusivity will now expire on April 6, 2015.

The FDA said Cephalon met the terms of a written request to provide data from studies examining the effect of Provigil, which treats sleep disorders, on pediatric patients.

Also, Cephalon said rights to market and sell a generic version of Provigil in the United States given to four generic firms following patent-infringement litigation will now become effective in April 2012.


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