Amgen, Bayer, Mylan Inc. generics news
Bayer and Onyx Pharmaceuticals Inc., now part of Amgen, filed suit in U.S. District Court for the District of Delaware alleging that an ANDA submitted by the Mylan Pharmaceuticals Inc. subsidiary of Mylan for a generic version of cancer drug Nexavar sorafenib infringes U.S. Patent Nos. 8,618,141 and 8,877,933. The patents cover the use of aryl ureas with angiogenesis inhibiting activity and a thermodynamically stable form of a tosylate salt, respectively. The ANDA contained a Paragraph IV certification saying that the patents are invalid, unenforceable and/or would not be infringed by Mylan’s product. The ‘141 patent expires on Feb. 11, 2023, and the ‘933 patent expires on Dec. 24, 2027. Mylan said it believes it was the first applicant to submit an ANDA for the generic version of Nexavar, which would entitle the company to 180 days of generic market exclusivity when the patents expire. Mylan has until March 25 to respond to the complaint. ...