Mylan NV has won FDA approval of the first generic version of a 40mg dose of Teva Pharmaceutical Industries Ltd.'s Copaxone (glatiramer) for multiple sclerosis, setting Mylan up for a potentially lucrative commercial opportunity while adding to Teva's mounting challenges.
The news, announced after market close Oct. 3, took investors from both companies by surprise since Mylan's management recently warned investors not to expect any of its complex generics pending at the US FDA to be approved until 2018, citing the challenging environment at the agency
Mylan said it plans to launch the drug "imminently," but provided no details on the timeline. The product is the subject of an appeal in a patent infringement case filed by Teva. A district court judge already ruled that patents on the 40mg product are invalid and the Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) ruled that three patents covering the 40mg dose are unpatentable
