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Adalvo announces successful DCP approval for Teriflunomide 14 mg film-coated tablets

22 September 2022

Adalvo is delighted to announce the successful DCP approval of our Teriflunomide 14 mg film-coated divisible tablets.

Our product is a fully bioequivalent version of Aubagio 14mg film-coated tablets, furthermore being a divisible tablet with one product we can cover the 7 mg strength needed for the treatment of pediatric population. This product has been co-developed in collaboration with one of our strategic partners.

Aubagio is a blockbuster specialty drug and is indicated for the treatment of relapsing remitting multiple sclerosis. The brand sold $2.7 billion in 2021 globally, as reported by IQVIA.

Based on this positive progress, we will proceed to launch this product, within respective markets, as soon as regulatory exclusivities and patents allow us.

Adalvo is working on several interesting CNS projects, as depicted below. This highlights our ability to offer differentiated, value-added products to our partners.

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