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Generic Imitrex approval

This article was originally published in The Tan Sheet

Executive Summary

FDA grants Teva Pharmaceuticals tentative approval for a generic version of GlaxoSmithKline's migraine treatment Imitrex Nov. 29. Final approval of the 25 mg, 50 mg and 100 mg Sumatriptan Succinate Tablets is expected upon expiry of patent protection in February 2009, according to the Jerusalem-based company. In October, Dr. Reddy's announced it will launch an "authorized" generic version of the drug in Q4 2008 (1"The Tan Sheet" Oct. 16, 2006, In Brief)...

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Generic Imitrex

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...

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