Table of Contents
PITTSBURGH — In the wake of a court decision, Mylan Inc. plans to roll out enteric-coated budesonide capsules, a medication for Crohn’s disease.
The company said late Thursday that the U.S. District Court for the District of Delaware ruled that its Mylan Pharmaceuticals Inc. subsidiary doesn’t infringe patent claims with its Abbreviated New Drug Application (ANDA) for 3-mg budesonide capsules (enteric-coated), the generic version of AstraZeneca’s Entocort EC capsules.
According to Mylan, its product is the first generic version of Entocort EC to be introduced to the U.S. market. Mylan said it received final approval from the Food and Drug Administration for its budesonide capsules on May 16.
Mylan Pharmaceuticals plans to ship the product immediately. The company reported that based on IMS Health figures, budesonide capsules (3 mg) had U.S. sales of about $350 million for the 12 months ended March 31.
