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Adalvo announces DCP approval for Dimethyl Fumarate 120mg, 240mg hard capsules

15 July 2022

Adalvo is delighted to announce the successful DCP closure of our Dimethyl Fumarate 120mg, 240mg hard capsules in Europe. 

Our product has been developed based on the reference brand Tecfidera, which is indicated in the treatment of elapsing remitting multiple sclerosis.  The product sold at around $2.8 billion globally in 2021, according to IQVIA. 

We believe to be one of the first Companies to receive an EU approval and based on this positive news, we will proceed to launch this product, within respective markets, as soon as regulatory exclusivities and patents allow us. 

We will continue growing our presence in this indication, along with our partners, reinforcing their position as key companies for this segment.

Apart from Dimethyl Fumarate, we are targeting to be among the first companies to launch Teriflunomide and Cladribine. Our teams will be available to share more details.

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