Kelun Pharma has received China National Medical Products Administration (NMPA) approval for its generic enzalutamide tablets, marking the first domestic authorisation for a tablet formulation of the AR inhibitor used in castration-resistant prostate cancer (CRPC). The approval follows earlier soft capsule generic versions from Hansoh Pharmaceutical, Qilu Pharmaceutical and Kelun Pharma approved since 2019, while the originator from Astellas and Pfizer remains available only in capsule form. Enzalutamide holds three indications, covering metastatic and non-metastatic CRPC plus metastatic hormone-sensitive prostate cancer, with multiple generic manufacturers competing in an estimated USD 200 million annual market.

The tablet formulation offers an alternative administration option for patients experiencing swallowing difficulties or preferring solid dosage forms with potential bioavailability advantages. Kelun Pharma becomes sole company holding approvals for both soft capsule and tablet formulations of enzalutamide, providing a comprehensive product portfolio in the urological oncology segment.

PharmCube's NextPat® database lists 37 enzalutamide patents, set to expire between 29 March 2026 and 13 December 2044. Click here to request a free trial for NextPat®.