Biogen has secured a new patent in Europe covering the use of its oral therapy Tecfidera (dimethyl fumarate) for multiple sclerosis (MS) through 2028, the company announced.
Granted by the European Patent Office, patent EP2653873 covers the composition and use of dimethyl fumarate at a dose of 480 milligrams per day — Tecfidera’s recommended maintenance dose in the EU — according to a Biogen press release.
It includes amended claims relative to a previous patent (EP2137537), and is expected to be published in the European Patent Bulletin in the coming weeks, Biogen said.
The new patent will last until February 2028. That means that Tecfidera’s oral generics — medications that are identical to the brand-name product but are typically sold at a lower price — likely will not enter the European market until the patent expires.
Generic approval follows a rigorous review process to ensure that the generic alternative contains the same active ingredient, strength, dosage form, and route of administration as the original brand-name product — in this case, Tecfidera.