Watson's Generic Boniva Approved - Analyst Blog

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Watson Pharmaceuticals Inc. ( WPI ) recently announced that the US Food and Drug Administration (FDA) has approved the company's abbreviated new drug application (ANDA) for a generic version of Roche Holding Ltd. 's ( RHHBY ) drug, Boniva. Boniva is currently approved for the treatment of postmenopausal osteoporosis.

Watson Pharma plans to begin shipping its generic version (150 mg) in the second quarter of 2012. Roche and Watson Pharma are currently fighting a patent infringement lawsuit for the ANDA of Boniva.

According to IMS Health, US sales of Boniva amounted to $510 million for the year ended January 31, 2012.

Earlier during the week, Watson Pharma filed an ANDA with the FDA to market a generic version of Abbott Laboratories' ( ABT ) cholesterol drug, Niaspan.

In response, Abbott Labs filed a lawsuit against Watson Pharma in the United States District Court for the District of Delaware. Abbott Labs is seeking to prevent the generic company from commercializing its product before the patents expire. Since the lawsuit was filed under the provisions of the Hatch-Waxman Act, therefore the FDA cannot approve Watson Pharma's ANDA until 30 months from the date Abbott Labs received the notice for the ANDA filing or until the court order, whichever is earlier.

Our View

We currently have a Neutral recommendation on Watson Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short run.

We expect new generic product launches over regular intervals to help drive the company's Global Generic segment's sales, which climbed 46% during 2011 to $3.32 billion, driven by the generic launch of Pfizer Inc. 's ( PFE ) Lipitor and Johnson & Johnson 's ( JNJ ) Concerta.


 
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: ABT , JNJ , PFE , WPI

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