Actavis seeks FDA approval to market Isotretinoin Capsules

Oct 31 2013

Actavis plc (NYSE: ACT) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Isotretinoin Capsules, 10 mg, 20 mg, 30 mg and 40 mg.  Actavis' ANDA product is a generic version of Ranbaxy Inc.'s Absorica^®, which is a retinoid indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older.

Cipher Pharmaceuticals, Inc., Galephar Pharmaceutical Research, Inc., Ranbaxy, Inc. and Ranbaxy Pharmaceuticals, Inc. filed suit against Actavis on October 29, 2013, in the U.S. District Court for the District of New Jersey seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. Patent No. 8,367,102.  The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Based on available information, Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Absorica^® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the 12 months ending September 30, 2013, Absorica^® had total U.S. sales of approximately $97 million, according to IMS Health data.