Depomed, a specialty pharmaceutical company that commercializes products for pain and neurology related disorders, has entered into a settlement agreement with Actavis in Depomed's patent infringement litigation related to Actavis's Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of Depomed's Gralise (gabapentin) 300 mg and 600 mg tablets.
The settlement permits Actavis to begin selling generic versions of Gralise on January 1, 2024, or earlier under certain circumstances.
"We are pleased with this settlement, as it confirms the expected period of market exclusivity for Gralise and avoids the expense of an appeal," commented Jim Schoeneck, president and chief executive officer of Depomed.
The settlement dismisses Actavis's pending appeal with the United States Court of Appeals for the Federal Circuit of the August 2014 trial court decision finding all seven Depomed patents asserted in the litigation, which expire between 2016 and February 2024, to be valid and infringed. The settlement agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission, and entry of orders dismissing the appeal and related federal district court litigation.
In April 2014, Depomed announced settlements with two other Gralise ANDA filers providing for generic entry on January 1, 2024. Upon dismissal of the Actavis litigation, all pending Gralise ANDA litigation will have been resolved.