Imitrex Patent Settlement Allows For Entry During Pediatric Exclusivity Period
This article was originally published in The Pink Sheet Daily
Executive Summary
Spectrum/Par say launch of subcutaneous sumatriptan could come as early as Aug. 6, 2008.
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Generics of the subcutaneous formulation of GlaxoSmithKline's migraine treatment Imitrex (sumatriptan) could hit the market up to six months earlier than expected under a patent litigation settlement announced Nov. 13. Irvine, Calif.-based Spectrum Pharmaceuticals and its distribution partner Par Pharmaceuticals said that under the settlement, which is subject to regulatory review, "authorized" generics of certain dosage strengths of the sumatriptan injections could launch as early as Aug. 6, 2008, when Imitrex's pediatric exclusivity begins. The latest the launch would occur is Nov. 6, 2008, Spectrum said. Imitrex injection comes in two dosage strengths: One contains 4 mg of sumatriptan as the base, while the other has 6 mg. GSK declined to say whether Spectrum/Par would produce all "authorized" generic versions of the injection, citing confidentiality. Last month, Dr. Reddy's said it would launch authorized generics of Imitrex 25 mg, 50 mg, and 100 mg tablets in the fourth quarter of 2008, under a separate settlement with GSK (1 (Also see "Imitrex "Authorized" Generic Launch Planned In Q4 2008" - Pink Sheet, 10 Oct, 2006.)). Par became involved in Spectrum following a February 2006 agreement for Par to help develop and market generic drugs. The ANDA for sumatriptan injection was filed in 2004; it received tentative FDA approval in October of this year (2 (Also see "Par To Market Generic Imitrex Through Deal With Spectrum" - Pink Sheet, 23 Feb, 2006.)). Par and Spectrum say they believe Spectrum was the first ANDA filer. According to GSK's annual report, 2005 worldwide sales of the company's Imitrex/Imigran franchise totaled $1.32 bil. GSK and its partner Pozen are pushing for a mid-2007 launch of a next-generation migraine medicine, TreximaT , a tablet combining sumatriptan with naproxen (3 (Also see "GlaxoSmithKline/Pozen Anticipate Mid-2007 Launch For Trexima Migraine Combo" - Pink Sheet, 4 Aug, 2006.)). Pozen announced Nov. 9 that it had submitted a full response to FDA's "approvable" letter for TreximaT; the product, formerly called Trexima, now has a May 6, 2007 user fee date, the company said. - Jonathan M. Block ([email protected]) |