Mylan introduces generic Entocort EC capsules for treatment of Crohn's disease

Mylan Inc. (Nasdaq: MYL) today announced that the U.S. District Court for the District of Delaware has found after trial that Mylan subsidiary Mylan Pharmaceuticals Inc. does not infringe the asserted claims of U.S. Patent No. 5,643,602 with its Abbreviated New Drug Application (ANDA) for Budesonide Capsules, 3 mg (Enteric Coated), the generic version of AstraZeneca's Entocort EC® capsules, a treatment for Crohn's disease.  

Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Budesonide Capsules, 3 mg, ANDA on May 16. This is the first generic version of this product to be introduced to the U.S. market, and Mylan Pharmaceuticals will be shipping this product immediately.

Budesonide Capsules, 3 mg, had U.S. sales of approximately $350 million for the 12 months ending March 31, 2011, according to IMS Health.

Currently, Mylan has 164 ANDAs pending FDA approval representing $94.2 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2010, according to IMS Health.