Generic companies have been filing late patent challenges against Lixiana (edoxaban), the market leader in the direct-acting oral anticoagulants (DOACs) market.

This is due to the imminent expiry of the product's formulation patent, which is 2 years away. The strategy of the patent challengers is to avoid the formulation patent and launch generics early upon the expiry of the product patent in November 2026.

According to industry sources on the 3rd, Dongkwang Pharmaceutical recently filed a trial to confirm the passive scope of Lixiana's formulation patent against Daiichi Sankyo. Prior to Dongkwang Pharmaceutical, Theragen Etex also filed a challenge to avoid the