Mylan Launches Generic Versions of Trilipix Caps

Mylan Inc.

today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Fenofibric Acid Delayed-release Capsules, 45 mg and 135 mg. Fenofibric Acid Delayed-release Capsules, 45 mg and 135 mg, are the generic version of Abbott's Trilipix® Capsules, which are indicated as an adjunct to diet in combination with a statin to reduce triglyceride and increase high-density lipoprotein cholesterol in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their low-density lipoprotein cholesterol goal. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Fenofibric Acid Delayed-release Capsules, 45 mg and 135 mg, had U.S. sales of approximately $553.6 million for the 12 months ending March 31, 2013, according to IMS Health. Currently, Mylan has 174 ANDAs pending FDA approval representing $83.2 billion in annual sales, according to IMS Health. Thirty-six of these pending ANDAs are potential first-to-file opportunities, representing $22.9 billion in annual brand sales, for the 12 months ending Dec. 31, 2012, according to IMS Health.