Mylan Faces Aptalis Challenge

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Mylan Inc. (MYL) recently announced that it has been sued by the privately held Aptalis Pharma. The patent challenge follows Mylan’s filing of an abbreviated new drug application (ANDA) as it seeks to market its generic version of Aptalis Pharma’s ulcerative proctitis drug Canasa (mesalamine).

Mylan believes it may be the first-to-file an ANDA for a generic version of Canasa – if this is the case, Mylan would be entitled to 180 days of exclusivity on gaining approval from the US Food and Drug Administration (:FDA) for its candidate. As per IMS Health data, Canasa sales in the US were $153 million for the twelve months ended Mar 31, 2013.

Mylan, one of the largest players in the global generics market, has a presence in more than 140 countries. As of Jul 11, 2013, the company had 173 ANDAs pending FDA approval, representing $82.9 billion in annual sales. These include 35 first-to-file opportunities.

Generic third-party net sales, derived from sales in North America, Europe, the Middle East & Africa and Asia-Pacific, came in at $1.41 billion in the first quarter of 2013, accounting for bulk of the company’s total revenues. Mylan’s generics business has been consistently performing well.

Mylan’s generic unit 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) erectile dysfunction drug Viagra.  Dr. Reddy's Laboratories Ltd. (RDY) too has been making multiple generic launches over the past few months.

Mylan carries a Zacks Rank #2 (Buy). Simcere Pharmaceutical Group (SCR) appears to be equally attractive.

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