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Mylan Inc.(MYL - Analyst Report)) recently announced that it has launched its generic version of Pfizer's (PFE - Analyst Report) 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) region.
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.
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