Mylan Inc. (MYL) recently announced that it has launched its generic version of Lupin Atlantis Holdings, S.A.'s Antara capsules (fenofibrate - 43 mg and 130 mg). The company started shipping the product following the receipt of final US Food and Drug Administration (:FDA) approval.
Antara is approved as an adjunct to diet to reduce elevated LDL-C, total-C, triglycerides, and Apo B. It is also indicated to increase HDL-C in adults with primary hypercholesterolemia or mixed dyslipidemia and to reduce triglyceride (TG) levels in patients with severe hypertriglyceridemia. Fenofibrate capsules generated US revenues of approximately $60 million for the 12 months ending Sep 30, 2012, as per data released by IMS Health.
As of Feb 25, 2012, Mylan had 184 abbreviated new drug applications (ANDAs) pending FDA clearance, targeting $80.7 billion in sales annually. Mylan believes that about 36 of these pending ANDAs are first-to-file opportunities, representing $21.1 billion in branded sales. The revenue figures are as per IMS Health for the 12 months ending June 30, 2012.
In Jan 2013, Mylan announced that it received final approval from the FDA TO market its generic versions of Merck & Co. Inc.'s (MRK) Maxalt MLT and Maxalt tablets. They are indicated for the acute treatment of migraine with or without aura in adults.
Mylan’s geographic reach and robust generic product portfolio are contributing to the company’s overall growth. Additionally, Mylan’s impressive generic pipeline is also encouraging.
However, we remain cautious of the company’s performance in the Europe, Middle East and Africa (:EMEA) region.
Furthermore, as most of the large branded drugs are due to lose patent exclusivity within the 2017-2018 period, we have little visibility on the growth prospects of generic companies like Mylan beyond that timeframe.
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