) generic unit is its main growth driver. Bulk of the revenues of
the company is generated from generic third-party net sales,
derived from sales in North America, Europe, the Middle East
& Africa (EMEA) and Asia-Pacific. Moreover, Mylan has a
strong generic pipeline and the company should continue
benefiting from a large number of high-value branded drugs
scheduled to go off patent in the next couple of years. These
patent expirations should boost the generic product portfolio of
Mylan is locked in multiple legal tussles over a number of
generic applications. For example, Mylan was sued by the
privately held Aptalis Pharma earlier this year. The patent
challenge followed Mylan's filing of an abbreviated new drug
application (ANDA) as it sought to market its generic version of
Aptalis Pharma's ulcerative proctitis drug Canasa (mesalamine).
) and Royalty Pharma Collection Trust sued Mylan over the ANDA
filed by the generic company with the U.S. Food and Drug
Administration (FDA) for its generic version of Savella
(milnacipran HCl tablets) at 12.5 mg, 25 mg, 50 mg and 100 mg
dosages. The branded version of the drug is approved (not in
pediatrics) for fibromyalgia management.
Mylan believes it may be the first-to-file an ANDA for a generic
version of Savella. If this is the case, Mylan would be entitled
to 180 days of exclusivity on gaining approval from the FDA. As
per IMS Health data, Savella sales in the U.S. were $123 million
for the twelve months ended Jun 30, 2013.
Mylan, one of the largest players in the global generics market,
has a presence in more than 140 countries. As of Sep 25, 2013,
the company had 178 ANDAs pending FDA approval, representing
$83.8 billion in annual sales. These include 42 first-to-file
opportunities, representing $23.8 billion in annual sales. The
data released by IMS Health is for the twelve-month period ending
Dec. 31, 2012.
The segment has seen quite a few launches over the past few
months. One of the important recent launches includes the
company's generic version of
) erectile dysfunction drug Viagra.
Mylan carries a Zacks Rank #2 (Buy).
) is another Zacks #2 Ranked stock in the generic space.
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