Depomed wins in law suit seeking FDA orphan drug exclusivity for Gralise
US specialty drugmaker Depomed (Nasdaq: DEPO) says 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 the company's law suit against the US Food and Drug Administration seeking an order requiring the FDA to grant Gralise (gabapentin) orphan drug exclusivity for the management of post-herpetic neuralgia (PHN).
The court's ruling requires that the FDA grant orphan drug exclusivity for Gralise for the management of PHN, the company stated on Friday.
"We are pleased with the court's ruling," said Jim Schoeneck, Depomed's president and chief executive, adding: "With Orphan Drug exclusivity and the recently announced victory in our Gralise patent litigation against Actavis blocking generic Gralise until 2024 [The Pharma Letter August 24], we expect Gralise to benefit from nearly an additional decade of commercial exclusivity."
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