Alembic Pharma shares rise on USFDA nod for prostate cancer drug with $3 billion estimated market size

Shares of Alembic Pharmaceuticals Ltd. gained nearly 3% on Thursday, May 14, after the company received a tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Darolutamide Tablets, 300 mg.In an exchange filing, the company said the approved ANDA is therapeutically equivalent to Bayer HealthCare Pharmaceuticals Inc.’s reference listed drug, Nubeqa Tablets, 300 mg.

Darolutamide is an oral medication used to treat specific types of advanced prostate cancer.
Alembic Pharma said the drug 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 mCSPC in combination with docetaxel.According to IQVIA, Darolutamide Tablets, 300 mg, had an estimated market size of $3.16 billion for the 12 months ending March 2026.

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

Last month, the company received final approval from the USFDA for its Fingolimod Capsules, 0.5 mg, which is used for the treatment of relapsing forms of multiple sclerosis. The drug had an estimated market size of $145 million for the 12 months ended December 2025.

Shares of the company gained as much as 3% following the USFDA nod announcement, but have since pared some gains and were trading at ₹778.45 as of 10.34 am, up 1.38%. The stock has gained about 6% over the past month, while delivering a negative 14% return in the last year.