Generic Imitrex
This article was originally published in The Tan Sheet
Executive Summary
Dr. Reddy's will launch an "authorized" generic version of GlaxoSmithKline's migraine treatment Imitrex (sumatriptan) in the fourth quarter of 2008, according to a patent-infringement settlement agreement announced by the companies Oct. 10. Settlement of the patent litigation allows for earlier entry of a generic version of Imitrex; the suit related to GSK's patent no. 5,037,845, which has pediatric exclusivity extending through February 2009. The agreement also allows India-based Dr. Reddy's to exclusively distribute generic Imitrex in the 25, 50 and 100 mg strengths. GSK filed the patent infringement suit against Dr. Reddy's in December 2003 after the company submitted an ANDA seeking approval of sumatriptan. A 50-mg dose of sumatriptan (marketed by GSK as Imigran Recovery) was approved for nonprescription "Pharmacy" sale by the UK's Medicines & Healthcare products Regulatory Agency in May (1"The Tan Sheet" May 22, 2006, p. 3). GSK is also working with its partner Pozen toward a mid-2007 launch of a next-generation Rx migraine medicine Trexima, combining sumatriptan with naproxen...
|
Dr. Reddy's will launch an "authorized" generic version of GlaxoSmithKline's migraine treatment Imitrex (sumatriptan) in the fourth quarter of 2008, according to a patent-infringement settlement agreement announced by the companies Oct. 10. Settlement of the patent litigation allows for earlier entry of a generic version of Imitrex; the suit related to GSK's patent no. 5,037,845, which has pediatric exclusivity extending through February 2009. The agreement also allows India-based Dr. Reddy's to exclusively distribute generic Imitrex in the 25, 50 and 100 mg strengths. GSK filed the patent infringement suit against Dr. Reddy's in December 2003 after the company submitted an ANDA seeking approval of sumatriptan. A 50-mg dose of sumatriptan (marketed by GSK as Imigran Recovery ) was approved for nonprescription "Pharmacy" sale by the UK's Medicines & Healthcare products Regulatory Agency in May (1 (Also see "GSK’s Imigran Recovery Is First Triptan Approved For Nonprescription UK Sale" - Pink Sheet, 22 May, 2006.), p. 3). GSK is also working with its partner Pozen toward a mid-2007 launch of a next-generation Rx migraine medicine Trexima , combining sumatriptan with naproxen.... |