Teva Pharmaceutical Industries Ltd.
) announced that the U.S. Food and Drug Administration (FDA) has
approved its generic version of
) Lovaza. Lovaza is used to lower very high triglyceride levels
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Teva believes that it was the first to file and the only company
to receive approval for generic Lovaza. Thus, the company may
enjoy 180 days of marketing exclusivity. The product will be
As per IMS data, as of Dec 31, 2013, Lovaza annual sales were
approximately $1.1 billion in the U.S.
We view the launch of Lovaza in the U.S. as an important generic
product launch for Teva this year and should boost the
performance of its generics business.
We note that the performance of Teva's U.S. generics business,
which generated approximately 21% of total revenues, was soft in
2013 with revenues declining 5% to $4.2 billion. This was
primarily due to the termination of a royalty agreement related
to the generic version of
) Lipitor. Lower sales from generic versions of Lexapro, Actos
and Actoplus also impacted revenues unfavorably.
On its fourth quarter conference call, the company stated that it
had 133 abbreviated new drug applications (ANDAs) pending FDA
approval, representing $81 billion in annual sales. These include
51 first-to-file opportunities, representing $40 billion in
annual sales. Since then, the company has launched several
products including generic versions of Xeloda and Evista.
Teva carries a Zacks Rank #2 (Buy). Some other stocks in the same
sector worth considering include
Dr. Reddy's Laboratories Ltd.
) carrying a Zacks Rank #1 (Strong Buy).