Mylan Inc's subsidiary Mylan Pharmaceuticals has begun shipping Fenofibrate capsules USP, 43 mg and 130 mg. This product is the generic version of Lupin Atlantis Holdings, S.A.'s Antara capsules, which are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, triglycerides, and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia and to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Fenofibrate has not been shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus.
Fenofibrate capsules USP, 43 mg and 130 mg, had US sales of approximately $60 million for the 12 months ending September 30, 2012, according to IMS Health. Mylan has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Currently, Mylan has 184 ANDAs pending FDA approval representing $80.7 billion in annual sales, according to IMS Health. Thirty-six of these pending ANDAs are potential first-to-file opportunities, representing $21.1 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.