Watson Pharmaceuticals Inc. (WPI) recently announced that it is seeking to launch a generic version of Genzyme’s (GENZ) Renvela (sevelamer carbonate). The company is seeking approval from the US Food and Drug Administration (FDA) for the phosphate binder that is approved for the control of serum phosphorus in chronic kidney disease patients who are on dialysis.

In response to the abbreviated new drug application (ANDA) filed by Watson, Genzyme has filed a patent infringement lawsuit in the US District Court for the District of Maryland. This means that Watson will not gain final approval for its generic version of Renvela for up to 30 months or until the court delivers a final decision, whichever occurs earlier.

We note that Watson is not the only company seeking to launch a generic version of the drug. Generic players like Lupin and Impax Laboratories are also looking to launch generic versions of Renvela. According to IMS Health, Renvela delivered US sales of $200 million in the past 12 months ending March 31, 2010.

Watson has initiated several new patent challenges this year. The company recently filed abbreviated new drug applications for Eli Lilly’s (LLY) Evista, Abbott’s (ABT) Simcor and TriLipix, Pfizer’s (PFE) Rapamune, and Teva’s (TEVA) Cenestin, among others.

At the end of the first quarter of 2010, Watson had 100 ANDAs pending approval with the FDA. New product launches over regular intervals should help drive the generics business. Watson expects generic segment sales in the range of $2.25 – $2.4 billion in 2010.

We currently have a Neutral recommendation on Watson. We believe that the company’s cost savings initiative and new product launches, both branded and generic, will help drive growth. We also view the company’s acquisition of Arrow as a smart strategic move. This acquisition should help boost Watson’s product portfolio and expand its footprint in ex-US territories.

However, integration risks remain and competition in both the branded and generic markets remain fierce.
Read the full analyst report on “WPI”
Read the full analyst report on “GENZ”
Read the full analyst report on “LLY”
Read the full analyst report on “ABT”
Read the full analyst report on “PFE”
Read the full analyst report on “TEVA”
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