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Mylan Launches Generic Entocort EC Capsules After Winning Patent Litigation

Generic drug maker Mylan, Inc. (MYL) announced Thursday the launch of the generic version of AstraZeneca plc's (AZN) Entocort EC capsules, a treatment for Crohn's disease, after its subsidiary Mylan Pharmaceuticals, Inc. won a patent litigation.

Mylan's Budesonide Capsules, 3 mg or Enteric Coated is the generic version of AstraZeneca's Entocort EC capsules. It is indicated for mild to moderate Crohn's disease involving the ileum and/or the ascending colon.

The U.S. District Court for the District of Delaware found after a trial that Mylan Pharmaceuticals did not infringe the asserted claims of U.S. Patent No. 5,643,602 with its Abbreviated New Drug Application (ANDA) for Budesonide Capsules.

Mylan said it received final approval from the U.S. Food and Drug Administration for its Budesonide Capsules, 3 mg, ANDA on May 16. The company said that Mylan Pharmaceuticals will ship this product immediately.

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

Mylan noted that it currently has 164 ANDAs pending for FDA approval, representing about $94.2 billion in annual sales, according to IMS Health. It is to be noted that 45 of these are potential first-to-file opportunities, representing $25.8 billion in annual brand sales.

The bulk of Mylan's product portfolio, which tops 900 individual products, includes high quality, more affordable generic medications sold throughout the world. Generic drugs are chemically identical, tried-and-true versions of brand-name pharmaceuticals and typically cost far less than brand-name drugs.

The generics industry continues to grow as an aging population, a strong desire to reduce health care outlays, and an increasing reliance on generics continue to fuel demand.

MYL closed Friday's regular trading session at $22.92, up $0.07 or 0.31 percent on a volume of 5.04 million shares, lower than the three-month average volume of 5.38 million shares.

by RTTNews Staff Writer

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