Mylan Pharmaceuticals Inc., a subsidiary of
), recently announced that it has launched its generic versions of
Takeda Pharmaceutical Co. Ltd.'s
) diabetes drugs, Actos (pioglitazone) and Actoplus Met
(pioglitazone and metformin).
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The US Food and Drug Administration granted final approval to
Mylan's generic version of Actos, 15 mg, 30 mg and 45 mg and
Actoplus Met, 15 mg/500 mg and 15 mg/850 mg. Mylan will enjoy a
180-day period of marketing exclusivity on both the products.
According to IMS Health, Actos and Actoplus Met generated US
revenues of approximately $2.7 billion and $413 million for the 12
months ending June 30, 2012.
Teva Pharmaceutical Industries Ltd.
) gained approval for authorized generic versions of Actos, 15 mg,
30 mg and 45 mg and Actoplus Met 15 mg/500 mg and 15 mg/850 mg.
We note that
Watson Pharmaceuticals Inc.
) was also seeking to get its generic version of Actos, 15 mg, 30
mg and 45 mg, approved and gain 180 days of marketing exclusivity.
However, the FDA did not approve Watson's Abbreviated New Drug
Application (ANDA), which can now get delayed by up to six months.
Watson has filed a lawsuit against the FDA challenging the
regulatory body's decision.
As of August 17, 2012, Mylan had 166 ANDAs pending FDA clearance,
targeting $75.6 billion in branded sales annually. Mylan believes
that about 34 of these pending ANDAs are first-to-file
opportunities, representing approximately $21.7 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 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 timeframe.
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.