AstraZeneca has settlement their patent infringement litigation concerning pulmicort respules that was filed against Ivax Pharmaceuticals, Inc, a wholly owned subsidiary of Teva Pharmaceuticals USA.
The patent infringement litigation was filed by AstraZeneca following Teva’s submission to the USFDA of an abbreviated new drug application for a generic version of the drug.
In the settlement, apparently Teva concedes that the patents asserted by AstraZeneca in the patent litigation are valid and enforceable and also concedes that its generic version of Pulmicort Respules infringes AstraZeneca’s patents.
The settlement agreement will allow Teva to sell the budesonide inhalation suspension under an exclusive license from December 2009 onwards. AstraZeneca will receive a significant but undisclosed royalty on sales of Teva’s product, with the royalty dropping if additional at-risk generic products enter the marketplace.
The agreement apparently settles all claims regarding past US sales of Teva’s generic budesonide inhalation suspension and provides that any product already shipped will remain in the market.
