Alembic Pharmaceuticals has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Darolutamide Tablets, 300 mg. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product 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 (mCSPC) in combination with docetaxel.

Darolutamide Tablets, 300 mg, have an estimated market size of USD 3,155 million for 12 months ending March 2026, according to IQVIA.

Alembic has a cumulative total of 238 ANDA approvals (219 final approvals and 19 tentative approvals) from FDA.