Glenmark in patent challenge on Bayer skin drug

Drug-maker Glenmark faces legal action in the US from Bayer Healthcare Pharmaceuticals, regarding the latter’s skin drug Finacea. Glenmark said that it had filed an application with the US regulator to sell its version of generic Azelaic Acid (a gel product sold by Bayer under the brandname Finacea) in the US. This action triggered the patent suit from Bayer. Bayer group companies Intendis and Intraserv, filed the suit against Glenmark Generics Ltd and Glenmark Generics Inc on March 14, in the United States District Court of Delaware, seeking to prevent Glenmark from commercialising its product prior to the expiration of its US patent, Glenmark said. The lawsuit was filed under the provisions of the Hatch-Waxman Act, which triggers a stay of final FDA approval of Glenmark’s product for up to 30 months or until final resolution of the matter before the Court, whichever occurs sooner, Glenmark added. Based on available information, Glenmark may be a first applicant to file an application for the generic version of Finacea, it said, and may be entitled to 180 days of generic market exclusivity.