Impax Seeks Generic Detrol Approval; Pfizer Sues
From Associated Press (June 3, 2011)
NEW YORK -- Impax Laboratories Inc. said Friday that it is seeking approval for a generic version of the overactive-bladder drug Detrol and is being sued by Pfizer Inc., which makes the original.
Impax said it has filed for marketing approval of a generic version of immediate-release Detrol, or tolterodine, in doses of 1 milligram and 2 milligrams.
The Heyward, Calif., company said Pfizer sued it for patent infringement Tuesday. Pfizer's lawsuit prevents the Food and Drug Administration from approving Impax's product for 30 months, or until the lawsuit is resolved. The patents supporting Detrol begin to expire in March 2012, although a court could void those patents.
Pfizer also makes an extended-release version of Detrol. Impax said U.S. sales of the instant-release version were $62 million in the 12 months ended in March.
Shares of Impax fell 22 cents to $26.17 as the broader market opened lower Friday morning. Pfizer shares lost 17 cents to $20.83.
Posted: June 2011