Watson seeks to commercialize generic Avodart

PARSIPPANY, N.J. — Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The company filed an abbreviated new drug application to market dutasteride capsules in the 0.5-mg strength. The drug is a generic version of Avodart, which is made by GlaxoSmithKline.

GlaxoSmithKline last Friday confirmed that it filed suit against Watson under the Hatch-Waxman Act in the U.S. District Court for the District of Delaware. GSK is seeking to prevent the generic drug maker from commercializing its dutasteride capsules prior to the expiration of patent No. 5,565,467. GSK is hoping for a stay of final FDA approval of Watson's ANDA until Nov. 17, 2013, or until final resolution of the matter before the court, whichever occurs sooner.

For the 12 months ended April 30, Avodart had total U.S. sales of approximately $580 million, according to IMS Health data.

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