Biogen sues Teva over generic Vumerity

A proposed Teva Pharmaceutical generic drug to treat multiple sclerosis infringes patents relating to Vumerity (diroximel fumarate), according to a lawsuit filed by Biogen and Alkermes.

The complaint, filed Wednesday, March 17, at the District Court for the District of Delaware asked the court to block the copycat drug until the patents have fully expired.

Biogen and Alkermes sued Teva after it filed an Abbreviated New Drug Application, number 214206, at the  Food and Drug Administration seeking approval to manufacture and sell a generic version of Vumerity.

According to Biogen and Alkermes, Teva’s generic infringes three patents that protect Vumerity, which Alkermes licenses exclusively to Biogen.

The patents, US numbers 8,669,281; 9,090,558; and 10,080,733 are set to expire in September 2033, according to the FDA's Orange book.

Biogen launched Vumerity in November 2019, as a successor to its blockbuster MS treatment, Tecfidera (dimethyl fumarate).