Briefs: Glenmark challenges Bayer patent; FDA delays Merck & Co's sugammadex

Indian drugmaker Glenmark Generics confirms that it seeking US Food and Drug Administration approval for azelaic acid, gel 15%, a generic version of German drug major Bayer’s (BAYN: DE) Finacea, which is used to treat rosacea.

Glenmark said that Bayer subsidiaries Intendis GmbH, Intraserv GmbH and Bayer Healthcare Pharmaceuticals Inc filed suit against Glenmark Generics Limited and Glenmark Generics Inc on March 14, 2013, in the US District Court for the District of Delaware, seeking to prevent Glenmark from commercializing its product prior to the expiration of US Patent No 6,534,070, which expires in 2018. This law suit was filed under the provisions of the Hatch-Waxman Act, which triggers a stay of final FDA approval of Glenmark’s Abbreviated New Drug Application product for up to 30 months or until final resolution of the matter before the Court, whichever occurs sooner.

Based on available information, Glenmark believes it may be a "first applicant" to file an ANDA for the generic version of Finacea and may be entitled to 180 days of generic market exclusivity. According to the IMS health data quoted by Glenmark, for the 12 months ending September 30, 2012, Finacea had total US sales of around $ 95 million.