Watson confirms Simcor patent challenge

MORRISTOWN, N.J. A subsidiary of Watson Pharmaceuticals is challenging the patent to a drug for high cholesterol, Watson said Wednesday.

Watson Labs – Florida filed an application with the Food and Drug Administration to market simvastatin and niacin extended-release tablets in the 1,000-mg/20-mg strength.

The drug is a generic version of Abbott Labs’ Simcor, used to treat patients with high cholesterol for whom treatment of simvastatin or niacin alone is insufficient, and when non-drug measures have not been successful.

Abbott filed suit against Watson Tuesday in the U.S. District Corut for the District of Delaware in an effort to prevent Watson from commercializing its version of the drug before the expiration of eight patents covering Simcor, the last of which expires in 2018, according to FDA records. The lawsuit puts a stay of FDA approval of two and half years or until the two companies resolve the matter before the court.

Simcor had sales of $88 million in 2009, according to IMS Health.

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