European CHMP recommends the granting of a marketing authorisation for dabigatran generic (Dabigatran Etexilate Leon Farma)
Dabigatran Etexilate Leon Farma is a generic of Pradaxa, which has been authorised in the EU since 18 March 2008. Studies have demonstrated its satisfactory quality and its bioequivalence to Pradaxa.
Source:
European Medicines Agency
SPS commentary:
The final UK patent expiry date for dabigatran was August 2023. There are currently no generic dabigatran products licensed in the UK.