COURT OKS GENERIC IMITREX AGREEMENT AFTER FTC FAILS TO COMMENT

The U.S. District Court for the District of Delaware officially dropped the patent infringement litigation concerning a generic version of GlaxoSmithKline's (GSK's) migraine and cluster headache drug Imitrex (sumatriptan succinate), Spectrum Pharmaceuticals announced.

The dismissal comes after the FTC offered no comment during the 30-day review period in which the agency examined an agreement between Spectrum and GlaxoSmithKline to settle the Feb. 18 infringement lawsuit over generic Imitrex.

Both companies had reached an agreement in November to sell authorized generic Imitrex. Spectrum will be the exclusive distributor of generic sumatriptan injection in the U.S. and it expects to launch the product during GSK's pediatric exclusivity period, set to begin Aug. 6, 2008. Specific terms of the agreement were not disclosed.

Spectrum had entered into an agreement with Par Pharmaceuticals to market sumatriptan injection.