Mylan Launches New Generics (ABT) (ISTA) (JNJ) (MYL) (NVS) (PRX) (TEVA) (WPI)

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Mylan Inc.’s (MYL) generic portfolio continued to be boosted with the launch of the generic version of Xanodyne Pharmaceutical’s pain reliever Roxicodone. The generic has been launched under a development and supply agreement with Coastal Pharmaceuticals.

The product recorded sales of $325 million in US for the twelve months endied March 31, 2011 according to data released by IMS Health.

We note that the launch of the generic version of the pain reliever is the latest in the series of generic launches at Mylan. A couple of days ago the company, which is one of the largest generic and specialty pharmaceutical companies across the globe, launched its generic version of Abbott Laboratories’ (ABT) Depakote Sprinkle Capsules for treating seizures.

The product recorded sales of $89 million in US for the twelve months ended March 31, 2011 according to data released by IMS Health.

Mylan had also recently launched the generic versions of Ista Pharmaceuticals Inc’s (ISTA) Xibrom ophthalmic solution and Johnson & Johnson’s (JNJ) schizophrenia drug Risperdal.

The generic segment which develops, manufactures, sells and distributes generic or branded generic pharmaceutical products in tablet, capsule or transdermal patch forms, accounts for the bulk of the revenues at Mylan. Management stated that it currently has167 abbreviated new drug applications (ANDAs) pending approval by the US Food and Drug Administration (FDA) targeting $100.3 billion in branded sales.

Mylan believes that approximately 45 of the pending ANDAs are first-to-file opportunities and represent a market opportunity in excess of $25.8 billion (in terms of branded sales).

Our Recommendation

We currently have a Neutral recommendation on Mylan. The company carries a Zacks #3 Rank (Hold rating) in the short-run. Mylan is one of the leading players in the US generics market.

The company holds immense potential as many blockbuster drugs are slated to lose patent exclusivity in the forthcoming period. We are encouraged by Mylan’s robust generic product pipeline.

However, competition in the generic segment is strong with players like Teva Pharmaceuticals (TEVA), Watson Pharmaceuticals (WPI), Par Pharmaceuticals (PRX) and Sandoz – the generics arm of Novartis (NVS) – in the field. We also remain concerned about the lack of growth in the European generics business. We intend to remain watchful until we get better visibility on top-line growth prospects in Europe.

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