Mylan Inc. (MYL) recently announced that it has launched first generic version of Novartis' (NVS) Diovan HCT (valsartan and hydrochlorothiazide) tablets, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg, after receiving final approval from the US Food and Drug Administration (:FDA).
Diovan HCT is used for the treatment of high blood pressure (:HBP). According to IMS Health, Diovan HCT (80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg tablets), generated US revenues of approximately $1.6 billion for the 12 months ending June 30, 2012. Mylan has already begun shipping the product.
We note that Novartis’ generic division Sandoz has recently introduced the authorized generic version of Diovan HCT in the US, while Novartis continues to market the branded Diovan HCT.
As of September 21, 2012, Mylan had 168 ANDAs pending FDA clearance, targeting $77.8 billion in branded sales annually. Mylan believes that about 33 of these pending ANDAs are first-to-file opportunities, representing approximately $20.8 billion in branded sales. The revenue figures are as per IMS Health for the 12 months ending June 30, 2012.
We are encouraged by Mylan’s geographic reach and product depth along with a robust generic product pipeline. However, we remain concerned about the company’s lackluster performance in the Europe, Middle East and Africa (:EMEA) region.
Additionally, with most large branded drugs due to lose patent exclusivity within the 2017-2018 period, we have little visibility on the growth prospects of generic companies like Mylan beyond that timeframe.
Thus, we prefer to remain on the sidelines and have a Neutral recommendation on Mylan. The stock carries a Zacks #2 Rank.
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