Adalvo submits generic dossier application for Dimethyl Fumarate hard capsules

12 July 2021

Adalvo is pleased to announce that in light of the most recent General Court decision that revoked data exclusivity protection on Dimethyl Fumarate (Tecfidera®) hard capsules, we have submitted our generic dossier application in a DCP procedure.  Based on available information, Adalvo believes it is in the first wave of applicants to expect an approval within the European Union.

Adalvo’s product is a generic version of Biogen’s hard capsules, which is indicated for the treatment of relapsing remitting multiple sclerosis. The product has been developed by one of our strategic partners in an exclusive licensing collaboration for almost all global markets. In 2020, Tecfidera® had global sales of approximately $4.6 billion, according to IQVIA.

A fast-growing portfolio!

With its global partners, Adalvo has built a dynamic high-value portfolio of more than 60 products and today’s announcement further enhances the company’s exceptional ability to be prepared for the unexpected. Adalvo currently serves patients through commercial partnerships in more than 60 countries around the world. Partner up now!

Disclaimer: Dimethyl Fumarate hard capsules which is subject to patent protection is currently not offered or made available in countries where patents are in force.