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Good News for Mylan's Generic Unit

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Recently, Mylan Inc.’s (MYL - Free Report) generic segment received encouraging news when the US Food and Drug Administration (FDA) granted final approval to its Abbreviated New Drug Application (ANDA) seeking consent to market its generic version of Sunovion’s Xopenex inhalation solution. Sunovion is an indirect, wholly-owned subsidiary of Japanese company, Dainippon Sumitomo Pharma Company Limited.

Mylan has commenced the shipment of the drug following the receipt of the final approval from the FDA. The drug is approved for the treatment or prevention of bronchospasm in adults, adolescents and children (6 years and above), suffering from reversible obstructive airway disease.

Mylan has a strong generic product portfolio and pipeline. As of Mar 18, 2013 the company’s generic unit had 182 ANDAs pending approval by the US regulatory body. The ANDAs represent annual sales worth $80 billion, according to data released by IMS Health. Mylan believes that 36 of these pending ANDAs are potential first-to-file opportunities. Data released by IMS health further revealed that the 36 ANDAs represent annual branded sales worth $21.1 billion, for the 12 months ending Jun 30, 2012.

We note that the company has received quite a few approvals on the generic front over the past few months.

Our Take

Mylan’s geographic reach and product depth, along with a robust generic pipeline, are contributing to its overall growth. We are also pleased with Mylan’s focus on emerging markets. Over the long term, the biggest opportunities for growth in the generics industry would be expansion in emerging markets.

However, we remain cautious of the company’s performance in Europe, 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.

Mylan carries a Zacks Rank #3 (Hold). Companies like Lannett Company, Inc. (LCI - Free Report) , WuXi PharmaTech (Cayman) Inc. and QLT Inc. look more attractive in the pharma space with a Zacks Rank #1 (Strong Buy).

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