) recently announced the launch of its generic version of
) Zovirax ointment. 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 note that the branded version of the drug is marketed for
the management of initial genital herpes and in limited
non-life-threatening mucocutaneous herpes simplex virus
infections in immunocompromised patients.
We remind investors that the launch of the product, the first
generic version of Zovirax ointment, is the second generic launch
at Mylan in the space of a few weeks. Last month, Mylan launched
its generic version of Sunovion's Xopenex inhalation solution.
Sunovion is an indirect, wholly-owned subsidiary of Japanese
company, Dainippon Sumitomo Pharma Company Limited.
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
Mylan has a strong generic product portfolio and pipeline. As
of Apr 3, 2013 the company's generic unit had 178 ANDAs pending
approval by the US regulatory body. The ANDAs represent annual
sales worth $78.4 billion, according to data released by IMS
Mylan believes that 35 of these pending ANDAs are potential
first-to-file opportunities. Data released by IMS health further
revealed that the 35 ANDAs represent annual branded sales worth
$20.3 billion, for the 12 months ending Jun 30, 2012.
We note that Mylan has received quite a few approvals on the
generic front over the past few months. Apart from Mylan,
Dr. Reddy's Laboratories Ltd.
) too has been making multiple generic launches over the past few
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 lackluster
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 #2 (Buy).
) too carries a Zacks Rank #2 in the generic space.
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