Mylan Approved for Zinecard Generic - Analyst Blog

Mylan, Inc. 's ( MYL ) generic business was boosted further with the approval from the U.S. Food and Drug Administration (FDA) for its generic version of Pharmacia & Upjohn's Zinecard injection. Zinecard injection, which is a chemoprotective agent, recorded revenue of approximately $3.4 million for the trailing twelve months ending in September 2011.

As of November 28, 2011, the company had 161 abbreviated new drug applications (ANDAs) that were pending clearance by the FDA, targeting $97.7 billion in branded sales. Mylan believes that about 43 of these ANDAs are first-to-file opportunities, representing more than $26.9 billion in branded sales.

Earlier this month Mylan reached a settlement agreement with Novartis ( NVS ) relating to the generic version of the latter's bioidentical estrogen therapy Vivelle-Dot. As a result of the resolution, the lawsuit filed by Novartis will be dismissed and Mylan can launch a generic version of Vivelle-Dot on December 16, 2013, or earlier under certain circumstances. The deal is subject to review by the US Department of Justice and the Federal Trade Commission.

Our Recommendation

We currently have a Neutral long-term recommendation on Mylan. The shares carry a Zacks #3 Rank (short-term Hold rating). Mylan is one of the leading players in the US generics market. We are encouraged by the company's geographic reach and product depth along with its robust generic product pipeline. Nevertheless, we are concerned about lackluster growth in the European generics business. We intend to remain watchful until better visibility is obtained on top-line growth prospects in Europe.

Moreover, competition in the generic segment is strong with players like Teva Pharmaceuticals ( TEVA ), Watson Pharma ( WPI ) and Sandoz, the generics arm of Novartis, in the field.

MYLAN INC ( MYL ): Free Stock Analysis Report

NOVARTIS AG-ADR ( NVS ): Free Stock Analysis Report

TEVA PHARM ADR ( TEVA ): Free Stock Analysis Report

WATSON PHARMA ( WPI ): Free Stock Analysis Report

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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 Nasdaq, Inc.

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

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