Depomed: Court Grants Request Against FDA For Gralise Orphan Drug Exclusivity

(RTTNews) - Depomed Inc (DEPO) said Friday that Judge Kentaji Brown Jackson of the federal district court for the District of Columbia has granted the company's motion for summary judgment in its lawsuit against the U.S. Food and Drug Administration seeking an order requiring the FDA to grant Gralise (gabapentin) Orphan Drug exclusivity for the management of postherpetic neuralgia (PHN).

The court's ruling requires that the FDA grant Orphan Drug exclusivity for Gralise for the management of PHN.

"We are pleased with the court's ruling," said Jim Schoeneck, Depomed's President and Chief Executive Officer. "With Orphan Drug exclusivity and the recently announced victory in our Gralise patent litigation against Actavis blocking generic Gralise until 2024, we expect Gralise to benefit from nearly an additional decade of commercial exclusivity.