Perrigo Co Announces Settlement Of Clobetasol Propionate E-Foam 0.05% Patent Litigation

Perrigo Co announced that it has agreed to settle Hatch-Waxman litigation relating to Clobetasol propionate emulsion foam, 0.05% brought by Stiefel Research Australia Pty. Ltd., a GSK Company. Under the terms of the settlement, Perrigo can launch in the U.S., a generic version of Olux-E (clobetasol propionate) Foam 0.05% on February 1, 2013, or earlier under certain circumstances. Perrigo was the first applicant to submit a substantially complete ANDA with a paragraph IV certification and is entitled to 180-days of marketing exclusivity upon launch. Perrigo received tentative approval for this ANDA in October 2011 and this product was the result of a collaboration with Cobrek Pharmaceuticals.