Recently, Mylan Inc.‘s (MYL) subsidiary, Matrix Laboratories received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) capsules in two dosage forms (15 mg and 30 mg). Mylan plans to begin shipment of the product immediately. 

The drug is the generic version of Takeda Pharmaceuticals’ (TKPHY.PK) proton pump inhibitor Prevacid DR Capsules. According to IMS Health (RX), the branded version had US sales of approximately $3 billion for the 12 months ending June 30. 

Mylan received quite a few approvals in the recent past. In October, Mylan settled its dispute with Pfizer (PFE) related to the patent of antifungal drug Vfend (voriconazole), following which Mylan received the approval to launch the generic version of the drug. Additionally, in September, Mylan received FDA approval for its generic version of Bristol-Myers Squibb’s (BMY) Sinemet for the treatment of Parkinson’s. 

Mylan received a significant approval in the field of HIV treatment with Matrix receiving tentative FDA approval under the President’s Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for a fixed-dose combination of Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate tablets. Although Matrix will not be able to market the product in the US due to existing patents, the drug can be sold in many developing countries. 

Currently, Mylan has 125 ANDAs pending FDA approval representing $84.1 billion in annual brand sales, according to IMS Health. Among these, 37 are potential first-to-file opportunities, representing $19.2 billion in annual brand sales. 

We expect the Merck Generics acquisition to contribute significantly to Mylan’s long-term growth and help expand its footprint in non-US markets. Based on the strong third quarter earnings, Mylan raised its 2009 earnings guidance. The company now expects its earnings per share in the range of $1.24 – $1.28, up from the earlier guidance of $1.13 – $1.20. We have a Neutral recommendation on the stock.
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