US Court Rules in Favor of Mylan, Generic Version of Tecfidera

Inês Martins, PhD avatar

by Inês Martins, PhD |

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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).

A delayed-release capsule, Tecfidera is known to effectively reduce MS flares and slow disease progression. Its list price is reported to be about $2,026 for a two-week (14 day) supply at 120 mg.

Generics are nearly identical versions of an original brand medication that are usually sold at lower prices.

Mylan’s generic version is under FDA consideration as an abbreviated new drug application (ANDA), showing the proposed oral compound is comparable to the original Tecfidera in its chemical composition, dosage form, strength, route of administration, and side effects.

All relevant patents and legal exclusivities for the original medication typically must expire before a generic can enter a market.

Biogen’s U.S. patent (No. 8,399,514) was granted in 2013 claiming methods of treating MS with a 480 mg daily dose of dimethyl fumarate delayed release capsules.

The District Court ruling invalidated the patent, citing lack of an adequate written description of Tecfidera, whose worldwide sales were reported to be worth $4.43 billion for Biogen in 2019.

Mylan states in its release that it is likely one of first companies to file a completed ANDA with a Paragraph IV certification, showing that the patent is invalid or not infringed by the generic product.

If indeed its ANCA is the first submitted and approved, Mylan will have an exclusive right to market its oral generic of dimethyl fumarate for 180 days (about six months).

“Once approved and launched, we believe our generic Tecfidera will potentially be the first generic of any MS treatment in an oral solid dosage form available to patients in the U.S.,” Bresch said.

“Bringing a product like generic Tecfidera to market requires not only our extensive scientific and commercial expertise, but also our unwavering commitment to access through overcoming potential legal barriers to reach patients,” added Rajiv Malik, Mylan’s president.

“We look forward to bringing this important medicine to market as soon as possible, pending final FDA approval.”