) 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
We note that the company has received quite a few approvals on
the generic front over the past few months.
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
Mylan carries a Zacks Rank #3 (Hold). Companies like
Lannett Company, Inc.
WuXi PharmaTech (Cayman) Inc.
) look more attractive in the pharma space with a Zacks Rank #1
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