Actavis applies for approval of generic version of Absorica

Makers of branded version, Absorica, sue Actavis in federal court

DUBLIN — Actavis is seeking Food and Drug Administration approval for a generic drug used to treat acne, triggering a lawsuit in a federal court from the maker of the branded version, the company said Thursday.

The drug maker said it had filed with the FDA for approval of isotretinoin capsules in the 10-mg, 20-mg, 30-mg and 40-mg strengths. The drug is a generic version of Ranbaxy's Absorica, a retinoid used to treat severe, recalcitrant nodular acne in patients 12 and older.

In response to the filing, Ranbaxy, Galephar Pharmaceutical Research and Cipher Pharmaceuticals sued Ranbaxy for patent infringement earlier this week in the U.S. District Court for the District of New Jersey, hoping to prevent Actavis from launching its drug before the September 2021 expiration of one of their patents. Under the Hatch-Waxman Act of 1984, the lawsuit puts a stay of FDA approval on Actavis' product for 30 months, or until the companies settle.

Actavis said it was likely the first company to seek approval for a generic version of Absorica, which had sales of about $97 million during the 12-month period that ended in September, according to IMS Health.

 

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