Mylan Pharmaceuticals Inc., a subsidiary of
), recently announced that it has launched its generic version of
) Atacand HCT, a fixed dose combination hypertension therapy,
after receiving final approval from the US Food and Drug
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Mylan stated in its press release that it was the first company
to submit a complete abbreviated new drug application (ANDA) to
the US regulatory body containing a paragraph IV certification
for the 32/25 mg dosage of the drug. Consequently, the generic
player enjoys a 180-day period of marketing exclusivity on the
32/25 mg dosage of Atacand HCT. According to IMS Health, Atacand
HCT generated US revenues of approximately $56.3 million for the
12 months ending September 30, 2012.
As of December 5, 2012, Mylan had 178 ANDAs pending FDA
clearance, targeting $80.1 billion in branded sales annually.
Mylan believes that about 35 of these pending abbreviated new
drug applications (ANDAs) are first-to-file opportunities,
representing approximately $21.2 billion in branded sales. The
revenue figures are as per IMS Health for the 12 months ending
June 30, 2012.
We are encouraged by Mylan's geographic reach and product depth
along with a robust generic product pipeline. However, we remain
concerned about the company's lackluster 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 our Neutral recommendation on Mylan. The
stock carries a Zacks #2 Rank (Buy rating) in the short run.