Mylan Inc. (MYL) recently announced the launch of its generic version of AbbVie Inc.‘s (ABBV) cholesterol management drug, TriCor (fenofibrate, 48 mg and 145 mg tablets). Mylan launched the drug after receiving final approval from the US Food and Drug Administration regarding the Abbreviated New Drug Application (ANDA) for its generic version of the drug.
We remind investors that Mylan is not the first to enter the US market with its generic version of TriCor. In Nov 2012, Lupin Ltd. had launched its generic version of TriCor. According to IMS Health, TriCor (48 mg and 145 mg) generated US revenues of approximately $1.2 billion for the 12 months ending Mar 31, 2013.
Mylan has a strong generic product portfolio and pipeline. As of May 17, 2013, Mylan had 178 ANDAs pending FDA clearance, targeting $83.1 billion in sales annually. Mylan believes that about 34 of these pending ANDAs are first-to-file opportunities, representing $22.4 billion in branded sales. The revenue figures are as per IMS Health for the 12 months ending June 30, 2012.
Mylan carries a Zacks Rank #3 (Hold). Mylan’s geographic reach and product depth, along with a robust generic pipeline, are contributing to its overall growth.
However, we remain cautious of the company’s lackluster performance in Europe, the Middle East and Africa. Additionally, 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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