Alembic Pharmaceuticals receives USFDA approval for Venetoclax Tablets

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Venetoclax Tablets, 10 mg, 50 mg and 100 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Venclexta Tablets, 10 mg, 50 mg, and 100 mg, of AbbVie Inc. (AbbVie).

Venetoclax tablets are indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax tablets are also indicated, in combination with azacitidine, or decitabine, or low-dose cytarabine, for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.

Alembic was a first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Venetoclax Tablets, 10 mg, 50 mg and 100 mg. Therefore, with this approval, Alembic may be eligible for 180 days of generic drug exclusivity.

According to IQVIA, Venetoclax tablets, 10 mg, 50 mg and 100 mg, had an estimated market size of US $1,584 million in the United States for twelve months ending June 2026.