Generic formulations of dimethyl fumarate — currently sold as Tecfidera by Biogen — were given a green light to enter the U.S. market, after a federal court invalidated a patent protecting Tecfidera from generic competition as a multiple sclerosis (MS) treatment.
The ruling by the District Court for the Northern District of West Virginia in favor of Mylan opens the possibility that the company can launch its dimethyl fumarate product, should a request before the U.S. Food and Drug Administration (FDA) be approved. An FDA decision is expected by or before Nov. 16.
Biogen is expected appeal this ruling against its Tecfidera patient protection, Reuters reported, which is not due to expire until 2028. But an appeal could take up to a year to work its way through the courts.
“Today’s win is significant in that it brings Mylan one step closer to providing expanded treatment options for the thousands of Americans living with relapsing forms of MS,” Heather Bresch, Mylan CEO, said in a press release.
“The District Court decision clears the legal pathway for us to bring our dimethyl fumarate product to market, and we are working with the FDA to accelerate our regulatory approval target action date, which currently is November 16,” Bresch added.
Tecfidera is the most widely prescribed capsule treatment for adults with relapsing forms of MS, which include clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive MS (SPMS).