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Teva Up on FDA Nod for Generic Evista

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Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced that the U.S. Food and Drug Administration (FDA) has approved its generic version of Eli Lilly and Company’s (LLY - Free Report) Evista (60 mg). Evista is indicated for the prevention and treatment of osteoporosis in postmenopausal women and reduction of the risk of invasive breast cancer in postmenopausal women with osteoporosis and postmenopausal women at high risk of invasive breast cancer. Teva gained 1.27% on the news.

Teva plans to launch its generic version of Evista by the first week of Apr 2014. With Teva being the first to file, the company will enjoy 180 days of marketing exclusivity. As per IMS data, as of Dec 31, 2013, Evista annual sales were approximately $824 million in the U.S.

Our Take

We view the launch of Evista in the U.S. as one of the most important generic product launches for Teva this year and this 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 Pfizer’s (PFE - Free Report) Lipitor. Lower sales from generic versions of Lexapro, Actos and Actoplus also impacted revenues unfavorably.

On its fourth quarter and full year 2013 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.

Teva carries a Zacks Rank #3 (Hold). Other better-ranked stocks include Actavis (ACT - Free Report) carrying a Zacks Rank #2 (Buy).

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