The FDA has not granted orphan drug exclusivity to Gralise, even though the product was approved for orphan drug designation in November 2010 for the management of PHN and was approved for that use in January 2011.
The company through its law suit seeks the court to direct FDA to grant Orphan Drug exclusivity for Gralise.
Depomed president and chief executive officer James Schoeneck said though Depomed and the FDA have different perspectives on the statute and regulations relevant to orphan drug exclusivity for Gralise, the company appreciates the FDA’s consideration of its views.
"We filed this suit to ensure we have the opportunity to fully articulate our legal arguments in court," Schoeneck added.
Orphan drug exclusivity will give the company marketing exclusivity in the US to manage PHN until 28 January 2018, seven years after the date of Gralise’s approval for PHN.