Mylan Launches Generic of Biogen’s Blockbuster MS DrugBy
Mylan has launched a generic version of Biogen’s Tecfidera (dimethyl fumarate), a drug for treating relapsing multiple sclerosis (MS). Tecfidera is Biogen’s top-selling drug with 2019 global sales of $4.4 billion.
Mylan is launching dimethyl fumarate delayed-release capsules 120 mg and 240 mg. The company received approval from the US Food and Drug Administration earlier this month (August 2020).
In June 2020, Mylan received a favorable ruling by a federal district court in a patent dispute with Biogen over Tecfidera. The US District Court for the Northern District of West Virginia invalidated Biogen’s Tecfidera patent (US Patent No. 8,399,514). Biogen is appealing that decision.
Biogen’s total sales for Tecfidera in the US for the 12 months ending June 30, 2020 were approximately $3.79 billion, according to IQVIA and as reported by Mylan.