Mylan Pharmaceuticals Inc., a subsidiary of generic pharma major
), recently announced that it has received final approval from the
US Food & Drug Administration (FDA) for its generic version of
) Lipitor (atorvastatin). Mylan has already begun shipping the
Lipitor is used as an adjunct to diet in patients with primary
hypercholesterolemia and mixed dyslipidemia to reduce elevated
total cholesterol, low-density lipoprotein (LDL), and triglycerides
and to increase high-density lipoprotein (HDL) cholesterol.
According to IMS Health, Lipitor generated US revenues of
approximately $8.1 billion for the 12 months ending March 31,
Earlier this month, Mylan had launched generic Lipitor in
France, Belgium, the UK, the Netherlands and Ireland. In these
countries, Lipitor generated total sales of $1.6 billion for the 12
months ending December 31, 2011.
As of May 29, 2012, the company had 171 abbreviated new drug
applications (ANDAs) pending clearance by the FDA, targeting $84
billion in sales annually. Mylan believes that about 38 of these
ANDAs are first-to-file opportunities, representing approximately
$25.5 billion in branded sales. The revenue figures are, as per IMS
Health, for the 12 months ending December 31,
We are encouraged by Mylan's geographic reach and product depth
along with a robust generic product pipeline. However, we are
concerned about the company's lackluster performance in the Europe,
Middle East and Africa (EMEA) region.
Additionally, with most large branded drugs due to lose patent
exclusivity within 2017-2018, we have little visibility on the
growth prospects for generic companies like Mylan beyond that
Thus, we prefer to remain on the sidelines and have a Neutral
recommendation on Mylan. The stock carries a Zacks #3 Rank (Hold
rating) in the short term.
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