) recently announced that it has launched first generic version of
) 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
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
MYLAN INC (MYL): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis
To read this article on Zacks.com click here.
Thus, we prefer to remain on the sidelines and have a Neutral
recommendation on Mylan. The stock carries a Zacks #2 Rank.