Reference is made to the recent decision by the Federal Patent Court, where the Betmiga (Mirabegron) ’427 patent and its SPC, was declared invalid with effect, for Germany. This decision is not final and Astellas may file an appeal to the German Federal Court of Justice.
In this respect, we would like to provide an update on the status of our Mirabegron development. All activities are on track, and we will proceed with DCP submission, which is scheduled for June 2023. We are working diligently to obtain marketing authorisations in the near future.
This dossier has been developed with a non-infringing formulation, in collaboration with one of our strategic partners, based on the reference brand Betmiga prolonged release tablets. It is indicated in the treatment of urgency, increased micturition frequency and urgency incontinence. Adalvo has already successfully completed the necessary clinical trials.
The brand sold approximately $3131Mn globally in 2022, with a Global 3Y CAGR of 5%, according to IQVIA.
Adalvo is one of the few Companies able to complete this very difficult development of a complex product in the generic pharma space, which further showcases our ability to bring differentiated products to our partners, strengthening Adalvo's presence in the Urology segment.
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ajish.rajan@adalvo.com – Central & Eastern Europe, Russia & CIS
jose.rendueles@adalvo.com- North Europe, APAC, MENA & Israel
margarida.neves@adalvo.com – Brazil
marta.puig@adalvo.com - LATAM (exc. Brazil) & South Europe
paulo.rodriguez@adalvo.com – Europe
supreet.sharma@adalvo.com – UK/Ireland, North America & South Africa
arni.baldursson@adalvo.com - Head of Global BD&L
Disclaimer: Products which are subject to patent protection are currently not offered or made available in countries where patents are in force.