GSK has tentatively lost patent protection on two of its popular drugs: Coreg and Imitrex. Imitrex is the more profitable of the two, with 2004 sales of $1.1 billion in the US, but the loss of Coreg is substantial as well. Together the two had combined sales of almost $2 billion in 2004. 2005’s were even more impressive: $1.4 billion in the US and over $2.42 billion globally for Coreg. The announcement of the FDA’s approval of Mylan’s generic sumatriptan comes hot on the heels of Imigran (the UK name for Imitrex) going over-the-counter in that country in an effort to retain some of its sales.
Mylan will now have a mandatory 180 day monopoly on the sale of three strengths of Imitrex: 50mg, 100mg, and 150mg tablet forms thanks to the Hatch-Waxman Act that I’ve talked about before, provided GSK doesn’t pay them to not sell it so they can extend their effective patent life by another 6 months, which is certainly a possibility. Injectable and intranasal forms of Imitrex remain covered by patent, and I don’t think we’ll see Imitrex tablets going OTC in this country anytime soon.
[tags]Imitrex, GSK, Sumatriptan, medicine, pharmacy, Coreg, carvedilol[/tags]