This patent generally relates to dosing Silenor (doxepin) at least 3 hours after a meal to promote faster onset of action and reduce the potential for next-day residual sedation. This patent will expire no earlier than July 2027, and Somaxon has submitted to the US Food and Drug Administration the required information to list the patent in the Orange Book.
"Our most important corporate objective is to maximize sales of Silenor, and the issuance of this new patent relating to the Silenor food effect is an important catalyst in that effort because it expands the scope and duration of Silenor’s patent exclusivity," said Richard W. Pascoe, Somaxon’s president and CEO. "Based on Silenor’s differentiated clinical efficacy and safety profile, its non-scheduled status, and the reaction to the product to date from physicians and patients, we see significant growth potential for Silenor. We will continue to direct our Silenor commercial efforts at those activities which we believe can deliver meaningful results in 2011 and beyond."