Generic Launch at Mylan


Mylan Inc.’s (MYL) generic segment was boosted when the company launched its generic version of Pfizer Inc.’s (PFE) anti fungal drug Vfend (voriconazole). The product (oral suspension) was launched, following the final approval of Mylan’s abbreviated new drug application (ANDA) by the U.S. Food and Drug Administration (:FDA), to market its generic version of Vfend.

Since Mylan was the first-to-file an ANDA for a generic version of Vfend, the company was granted 180 days of marketing exclusivity. As per IMS Health data, Vfend sales in the U.S. were $17.1 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 30, 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.

Mylan’s 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 and Asia-Pacific. Moreover, Mylan has a strong generic pipeline and 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 carries a Zacks Rank #2 (Buy). Akorn, Inc. (AKRX) is another Zacks #2 Ranked stock in the generic space. Actavis, Inc. (ACT), another generic player, looks more attractive with a Zacks Rank #1 (Strong Buy).

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