Mylan Pharmaceuticals Inc., a subsidiary of generic pharma major
), recently announced that it has received final approval from the
U.S. Food & Drug Administration (FDA) for its generic version
of Boehringer Ingelheim's Viramune (nevirapine).
Viramune is approved for HIV-1 infection in combination with
antiretroviral (ARV) treatment. According to IMS Health, Viramune
generated U.S. revenues of approximately $116.6 million for the 12
months ending March 31, 2012.
Apart from Mylan, Prinston Inc., Hetero Labs Ltd III, Strides,
Cipla and Aurobindo Pharma have gained approval to market their
generic versions of Viramune.
Just a few days ago, Mylan Inc received final approval from the
FDA to launch its generic versions of Plavix (clopidogrel), 75 mg
and 300 mg. Plavix is sold by
Bristol-Myers Squibb Co.
) and 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,
As of May 23, 2012, the company had 173 abbreviated new drug
applications (ANDAs) pending clearance by the FDA, targeting $92
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 Dec. 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
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.
BRISTOL-MYERS (BMY): Free Stock Analysis Report
MYLAN INC (MYL): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis
To read this article on Zacks.com click here.