Mylan Pharmaceuticals Inc., a subsidiary of generic player,
), recently announced that it has received final approval from the
U.S. Food & Drug Administration (FDA) to launch generic
versions of Plavix (clopidogrel), 75 mg and 300 mg. Mylan was the
first company to have filed an abbreviated new drug application
(ANDA) to market a generic version of Plavix, 300 mg. The early
bird will thus enjoy a 180-day period of exclusivity.
Plavix, sold by
Bristol-Myers Squibb Co.
), is approved for patients who have had a heart attack or stroke
recently, or suffer from a partial or total blockage of an artery
(peripheral artery disease). According to IMS Health, Plavix
generated U.S. revenues of approximately $6.7 billion for the 12
months ending March 31, 2012.
Apart from Mylan, Apotex Corporation, Aurobindo Pharma, Roxane
Laboratories, Sun Pharma,
) and Torrent Pharmaceuticals gained approval for the 75 mg dosage
of clopidogrel. Meanwhile,
Dr. Reddy's Laboratories
), Gate Pharmaceuticals and Teva have received FDA approval for the
300 mg dosage of clopidogrel. Dr. Reddy's was also among the first
companies to file an ANDA for generic Plavix 300 mg and has 180
days of marketing exclusivity for the formulation.
As of May 17, 2012, the company had 173 ANDAs pending clearance
by the FDA, targeting $98.2 billion in branded sales. Mylan
believes that about 39 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, 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 Europe, the
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 timeframe.
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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