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Update on Mylan's Generic Unit

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Mylan Inc.’s (MYL - Free Report) 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.

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).

Forest Laboratories 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 Pfizer Inc.’s (PFE - Free Report) erectile dysfunction drug Viagra.  

Mylan carries a Zacks Rank #2 (Buy). Actavis, Inc. (ACT - Free Report) is another Zacks #2 Ranked stock in the generic space.

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