Watson seeks approval for generic Evista

MORRISTOWN, N.J. Watson Pharmaceuticals is challenging the patent covering a drug for postmenopausal women, the generic drug maker said Wednesday.

Watson said it would seek approval from the Food and Drug Administration for raloxifene hydrochloride, a generic version of Eli Lilly’s Evista, through a subsidiary. The drug is used by postmenopausal women to treat and prevent osteoporosis and reduce the risk of breast cancer.

Lilly sued Watson Monday in the U.S. District Court for the Southern District of Indiana to prevent Watson from commercializing its version of the drug before the expiration of three of the patents covering, the last of which expires in 2017, according to FDA records. The lawsuit prevents the FDA from granting final approval to Watson’s drug for 30 months or until the two companies resolve the matter in court, under the provisions of the Hatch-Waxman Act of 1984.

Evista had sales of $690 million during the 12-month period ended in March, according to IMS Health.

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