Alembic Pharmaceuticals Ltd on Thursday said it has received tentative approval from the US health regulator for its generic version of Darolutamide tablets indicated for treatment of prostate cancer.
The tentative approval by the U.S. Food and Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Darolutamide tablets of strength 300 mg, Alembic Pharmaceuticals said in a statement.
The approved ANDA is therapeutically equivalent to the reference listed drug product Nubeqa Tablets, 300 mg, of Bayer AG, it added.
Darolutamide is indicated for the treatment of adult patients with different types of prostate cancer in combination with docetaxel.
Market size pegged at over USD 3.1 billion
Citing IQVIA data, the company said Darolutamide tablets 300 mg had an estimated market size of USD 3,155 million in the 12 months ended March 2026.
Published on May 14, 2026