) recently announced that it has launched its generic version of
) Clarinex (desloratadine) 5 mg tablets after receiving final
approval from the US Food & Drug Administration (FDA).
Clarinex is approved for seasonal allergic rhinitis, perennial
allergic rhinitis and chronic idiopathic urticaria. According to
IMS Health, Clarinex (5 mg tablets), generated US revenues of
approximately $194.6 million for the 12 months ending March 31,
Meanwhile, Mylan also received final FDA approval for its generic
version of Noven Therapeutic's Lithobid (lithium carbonate)
extended-release 300 mg tablets. Lithobid is approved for manic
episodes associated with bipolar disorder. The product is also
approved as a maintenance therapy for bipolar disorder patients in
order to reduce the frequency and intensity of manic episodes.
As per IMS Health data, Lithobid 300 mg generated US revenues of
approximately $21 million for the 12 months ending March 31, 2012.
Mylan has begun shipping both products.
As of July 3, 2012, Mylan had 167 Abbreviated New Drug Applications
(ANDAs) pending FDA clearance, targeting $83.8 billion in branded
sales annually. Mylan believes that about 37 of these ANDAs are
first-to-file opportunities, representing approximately $25.6
billion in branded sales. The revenue figures are as per IMS Health
for the 12 months ending December 31, 2011.
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 the 2017-2018 period, we have little visibility
on the growth prospects of 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 #2 Rank (Buy
rating) in the short term.
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