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Mylan Launches First Generic Version of Entocort EC® Capsules

PITTSBURGH, June 23, 2011 /PRNewswire/ -- 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.

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. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit For more information about generic drugs, please visit

SOURCE Mylan Inc.
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