recently announced that it has launched its generic version of
) Dilantin Chewable Tablets (phenytoin - 50 mg). The company
started shipping the product following the receipt of final US
Food and Drug Administration (FDA) approval.
Dilantin is approved for controlling generalized tonic-clonic
(grand mal) and complex partial (psychomotor, temporal lobe)
seizures. It is also indicated for the prevention and treatment
of seizures at the time of or after neurosurgery. According to
IMS Health, phenytoin generated US revenues of approximately
$16.5 million for the 12 months ending September 30, 2012.
Mylan had 185 ANDAs pending FDA clearance, targeting $80.6
billion in sales annually. Mylan believes that about 35 of these
pending abbreviated new drug applications (ANDAs) are
first-to-file opportunities, representing $21.2 billion in
branded sales. The revenue figures are as per IMS Health for the
12 months ending June 30, 2012.
Mylan's geographic reach and product depth along with a robust
generic product pipeline are contributing to the company's
overall growth. However, we remain cautious of the company's
performance in the Europe, Middle East and Africa (EMEA)
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.
In view of these challenges, we see limited upside from
current levels and maintain a Neutral recommendation on Mylan.
The stock carries a Zacks #3 Rank (Hold) in the short run.
Currently, pharma companies like Valeant Pharmaceuticals
), carry a Zacks #1 Rank (Strong Buy).
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