Depomed sues FDA over orphan status exclusivity for Gralise

US drugmaker Depomed (Nasdaq: DEPO) says it has filed an action in federal district court for the District of Columbia against the Food and Drug Administration, seeking an order requiring the FDA to grant Gralise (gabapentin) Orphan Drug exclusivity for the management of postherpetic neuralgia (PHN).

Gralise received orphan drug designation in November 2010 for the management of PHN and was approved by the FDA for that use last year (The Pharma Letter January 31, 2011). The FDA has not granted orphan drug exclusivity to Gralise, even though the product was approved for its orphan-designated use. Depomed believes Gralise is entitled to Orphan Drug exclusivity as a matter of law, and the FDA's action is not consistent with the statute or FDA's regulations related to orphan drugs. The law suit seeks a determination by the court that Gralise is protected by Orphan Drug exclusivity, and an order that FDA act accordingly.

"Though we and the FDA have different perspectives on the statute and regulations relevant to orphan drug exclusivity for Gralise, we very much appreciate the FDA's consideration of our views," commented James Schoeneck, Depomed's president and chief executive, adding: "We filed this suit to ensure we have the opportunity to fully articulate our legal arguments in court."