As we strengthen our injection product pipeline, we are pleased to announce dossier readiness for Dalbavancin Injection will be complete by the end of 2022. We now proceed to dossier submission at a global level, and submission dates are already scheduled in 2023, following data exclusivity. We believe we will be among the few players able to offer a dossier, within Day-1 filing.
This complex antibiotic niche product has been developed based on the reference brand Xydalba (EU) / Dalvance (US), from Allergan, and is indicated in the treatment of acute bacterial skin and skin structure infections. The product sold at $183mio globally in 2021, with Global 3Y CAGR at 22%, according to IQVIA.
The positive status of this product further highlights our ability to offer difficult-to-make, high-value products to our partners, as we venture into this niche antibiotic segment. We expect to launch this product on Day-1 in all major markets, including the EU and US.