Actavis seeks approval for two generics

Drug maker challenges patents on Bayer, Fresenius Kabi drugs

PARSIPPANY, N.J. — Actavis is hoping to become the first to market generic versions of a contraceptive and a sedative, the drug maker said.

On Wednesday, Actavis said it had filed for approval with the Food and Drug Administration for a generic version of Bayer's Safyral (drospirenone, ethinyl estradiol and levomefolate calcium tablets; levomefolate calcium tablets), which prevents pregnancy and acts as a daily folate supplement. The filing prompted a patent-infringement suit by two subsidiaries of Bayer and a subsidiary of Germany-based Merck KGaA. The suit places an automatic stay of approval on the generic for 30 months, or until the companies settle the case.

And on Friday, Actavis filed for approval for a generic version of Fresenius Kabi's Diprivan (propofol) injection in the 10 mg-per-milliliter strength, a sedative and anesthetic. The filing also prompted a patent-infringement suit from Fresenius Kabi.

Safyral had sales of about $19 million during the 12-month period that ended in April, while Diprivan had sales of about $212 million during the same period, according to IMS Health.

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