Alembic Pharmaceuticals Limited has received tentative approval from the US Food & Drug Administration for Darolutamide Tablets, 300 mg,

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Nubeqa Tablets, 300 mg, of Bayer HealthCare Pharmaceuticals Inc..

Darolutamide is an androgen receptor inhibitor indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-sensitive prostate cancer (mCSPC), and metastatic castration-sensitive prostate cancer in combination with docetaxel.

According to IQVIA data for the twelve months ending March 2026, Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States.

With this approval, Alembic Pharmaceuticals now has a cumulative total of 238 ANDA approvals from the USFDA, comprising 219 final approvals and 19 tentative approvals.