Pulmicort generics on hold for a year

Executive Summary

Teva walks away with minor bruises from its preliminary injunction hearing against AstraZeneca for sale of generic Pulmicort Respules (budesonide inhalation suspension). The firm agreed to pay AstraZeneca an undisclosed royalty and halt further shipments until Dec. 15, 2009, under an agreement signed in New Jersey Federal Court Nov. 25. The patent settlement lifts Teva's temporary restraining order, enabling an estimated three to four months of already shipped inventory to remain on the market for further distribution. "The sheer brilliance of the strategy is that on Dec. 15, 2009, we get to do it all over again and Teva can ship generic Pulmicort with exclusivity economics since the settlement surely precluded an authorized generic," Needham analyst Eliot Wilbur says in a note. While the deal appears to shave almost nine years off Pulimcort's patent life - the earliest list patent expires in 2018 - the timing gives AstraZeneca some breathing room, as well as Teva, in what had been an at-risk launch (1"The Pink Sheet," Nov. 24, 2008, p. 17). Par, which was distributing an authorized generic, may be the only party in the drama not to benefit from the settlement