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Spectrum Pharmaceuticals announces that sumatriptan injection litigation with GlaxoSmithKline® has been dismissed pursuant to the settlement agreement
Spectrum Pharmaceuticals, Inc. announced today that patent litigation relating to sumatriptan injection, the generic version of GlaxoSmithKline's Imitrex® Injection, has been dismissed by the United States 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 United States with an expected launch during GSK's sumatriptan pediatric exclusivity period which begins on August 6, 2008, but with the launch occurring not later than November 6, 2008. Spectrum will launch sumatriptan injection through its partner for the sale and distribution of the drug, Par Pharmaceutical Companies, Inc."
As we expected, at our request the court has dismissed this patent litigation with GSK which will allow us to move forward under the previously announced settlement agreement for sumatriptan injection," stated Rajesh Shrotriya, M.D., Chairman, President and CEO of Spectrum. "This will enable our partner PAR Pharmaceutical to continue with the launch of sumatriptan injection ahead of GSK's patent expiration and allow us to begin receiving profits upon sales as early as 2008."
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 (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration seeking marketing clearance for sumatriptan injection, which was tentatively approved by the FDA in October 2006.