Spectrum Pharmaceuticals announced Dec. 21 that patent litigation relating to sumatriptan injection, the generic version of GlaxoSmithKline's (GSK) Imitrex Injection, has been dismissed by the U.S. District Court for the District of Delaware pursuant to the previously announced settlement agreement between Spectrum and GSK.
In November, Spectrum and GSK reached an agreement to settle patent litigation relating to sumatriptan injection. The terms of the confidential agreement provide that Spectrum may exclusively distribute authorized generic versions of certain sumatriptan injection products in the U.S. with an expected launch during GSK's sumatriptan pediatric exclusivity period, which begins on Aug. 6, 2008, but with the launch occurring not later than Nov. 6, 2008.
Spectrum will launch sumatriptan injection through its partner for the sale and distribution of the drug, Par Pharmaceutical Companies.
In February 2006, Spectrum entered into an agreement with Par Pharmaceutical to develop and market generic drugs for the company, including sumatriptan injection. In 2004, Spectrum filed an abbreviated new drug application containing a Paragraph IV certification with the FDA seeking marketing clearance for sumatriptan injection, which was tentatively approved by the FDA in October 2006.