Mylan Pharmaceuticals Inc., a subsidiary of
), recently announced that it has launched its generic version of
) Avapro (irbesartan) 75 mg, 150 mg and 300 mg tablets after
receiving final approval from the US Food and Drug Administration
Avapro is used for hypertension and type II diabetic nephropathy.
According to IMS Health, Avapro (75 mg, 150 mg and 300 mg tablets),
generated US revenues of approximately $400.7 million for the 12
months ending June 30, 2012.
Meanwhile, Mylan has also launched its generic version of Sanofi's
Avalide (150/12.5mg and 300/12.5 mg), a fixed-dose combination of
Avapro and a diuretic (hydrochlorothiazide) for initial use in
patients with hypertension, who might need several drugs control
their blood pressure. According to IMS Health, Avalide (150/12.5mg
and 300/12.5 mg tablets), generated US revenues of approximately
$117.4 million for the 12 months ending June 30, 2012.
Apart from Mylan, several other generic manufacturers including
Sandoz, the generic division of
Dr. Reddy's Laboratories Ltd.
) have received approval for their generic versions of Avapro and
Avalide. We note that
Teva Pharmaceutical Industries Ltd.
) was the first to receive approval for Avapro and Avalide in April
2012 and enjoyed a 180-day period of marketing exclusivity.
As of September 28, 2012, Mylan had 168 ANDAs pending FDA
clearance, targeting $79 billion in branded sales annually. Mylan
believes that about 33 of these pending abbreviated new drug
applications (ANDAs) are first-to-file opportunities, representing
approximately $20.7 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, 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 run.
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