Apalutamide is an oral second-generation androgen receptor antagonist approved by the US FDA in 2018 . For the treatment of non-metastatic castration-resistant and metastatic castration-sensitive prostate cancer, clinical guidelines recommend androgen receptor antagonists, such as apalutamide, in combination with androgen-deprivation therapy as the standard of care. With approval for both of these advanced prostate cancer types, apalutamide emerges as a key therapeutic option. Apalutamide primary patents are expected to expire in 2027. Secondary patents may provide exclusivity until 2033-2038 in many LMICs.

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