Mylan Inc. announced that the US District Court for the District of Delaware has found after trial that Mylan subsidiary Mylan Pharmaceuticals Inc. does not infringe the asserted claims of US 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 US 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 US market, and Mylan Pharmaceuticals will be shipping this product immediately.
Budesonide capsules, 3 mg, had US 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 December 31, 2010, according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories.