Spectrum announces initiation of Imitrex injection patent challenge.

Spectrum Pharmaceuticals, Inc. (Irvine, CA) announced that it has initiated challenge of the patent listed by GlaxoSmithKline in connection with GlaxoSmithKline's Imitrex injection 6mg/0.5mL. The exclusivity afforded the patent listed in the Orange Book for Imitrex injection expires on February 6, 2009. Spectrum's Abbreviated New Application (ANDA) for sumatriptan succinate injection alleges that the Orange Book listed patent is invalid, unenforceable and/or would not be infringed by Spectrum's product.

Spectrum submitted its ANDA containing a Paragraph IV certification for a generic Imitrex injection product with the United States Food and Drug Administration (FDA) in October 2004, and received notification of acceptance with Paragraph IV certification in January 2005. …