Biogen’s multiple sclerosis drug protected by new 15-year patent

Hannah Blake

pharmaphorum

Biogen’s multiple sclerosis drug, Tecfidera, has been granted additional patent protection by the US Patent and Trademark Office (USPTO). The new patent will hold off generic competition longer than anticipated, as it will expire in 2028 and covers the dosing regimen of daily administration of 480mg of Tecfidera (dimethyl funarate).

This regimen is also included in the proposed marketing application for Tecfidera, which is currently under review by the U.S. Food and Drug Administration (FDA).

Tecfidera is the company’s oral therapeutic candidate, and the only currently known investigational compound, for the treatment elapsing-remitting multiple sclerosis (RRMS) that has experimentally demonstrated activation of the Nrf-2 pathway.

“The patent for this dosing regimen is recognition of the remarkable innovation TECFIDERA represents for the MS community. The tremendous research investment required to study and validate the patented dosing regimen is an example of innovation that leads to meaningful benefits to patients.”

George A. Scangos, Ph.D., chief executive officer of Biogen Idec.

The European Patent Office also recently determined that Biogen Idec’s application for a patent covering the same dosing regimen of Tecfidera is allowable. Once granted, this patent would also expire in 2028.

Tecfidera is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.