Alembic Pharmaceuticals has received USFDA tentative approval for its Darolutamide Tablets, 300 mg, a medication used to treat various forms of prostate cancer. This product is therapeutically equivalent to the reference drug Nubeqa. With an estimated market size of US$ 3,155 million as of March 2026, this approval marks a significant milestone for the company’s portfolio, bringing its total number of ANDA approvals to 238.
Expanding the Oncology Portfolio
Alembic Pharmaceuticals continues to strengthen its presence in the global oncology market. On May 14, 2026, the company announced that it secured tentative approval from the US Food & Drug Administration (USFDA) for its Darolutamide Tablets, 300 mg. The approved Abbreviated New Drug Application (ANDA) is established as a therapeutic equivalent to the reference product, Nubeqa, marketed by Bayer HealthCare Pharmaceuticals Inc.
Strategic Market Opportunity
Darolutamide serves as a critical androgen receptor inhibitor. The approved medication is indicated for the treatment of adult patients managing non-metastatic castration-resistant prostate cancer (nmCRPC), as well as metastatic castration-sensitive prostate cancer (mCSPC), including treatments in combination with docetaxel. According to data from IQVIA, the drug represents a substantial market opportunity, with an estimated size of US$ 3,155 million for the twelve-month period ending March 2026.
Regulatory Milestone
This achievement reinforces Alembic’s commitment to providing accessible healthcare solutions worldwide. Following this latest development, the company’s cumulative portfolio now includes 238 ANDA approvals from the USFDA, consisting of 219 final approvals and 19 tentative approvals. This growth is supported by Alembic’s advanced research and manufacturing facilities, which remain a focal point of the company’s long-term strategy to expand its branded generics business.
Source: BSE
