FDAnews
www.fdanews.com/articles/90181-ortho-mcneil-sues-barr-over-generic-topamax

ORTHO-MCNEIL SUES BARR OVER GENERIC TOPAMAX

December 27, 2006

Ortho-McNeil Pharmaceutical has filed a patent infringement lawsuit to stop Barr Laboratories' move to offer a generic version of the epilepsy and migraine drug, Topamax.

In a Dec.18 complaint, filed in the U.S. District Court for the District of New Jersey, Ortho-McNeil charged that Barr's abbreviated new drug application to market topiramate capsules in 15- and 25-mg doses would infringe on its patent under the Federal Food, Drug and Cosmetic Act.

The company is seeking a judgment of infringement against Barr, payment for reasonable attorney's fees, a permanent injunction and a court order that will prevent FDA approval for any generic version of Topamax before the expiration date of its patent.

Topamax has annual U.S. sales of about $1.37 billion, according to industry sources.