Date: 30th October, 2026
Regulatory Approval Details
Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Venetoclax Tablets in three strengths: 10 mg, 50 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product Venclexta Tablets of AbbVie Inc.
Product Indications and Usage
Venetoclax tablets are indicated for:
- Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- Treatment, in combination with azacitidine, or decitabine, or low-dose cytarabine, for newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
Market Exclusivity and Position
Alembic was a first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Venetoclax Tablets. With this approval, Alembic may be eligible for 180 days of generic drug exclusivity in the US market.
Market Size and Commercial Potential
According to IQVIA data, Venetoclax tablets (10 mg, 50 mg and 100 mg) had an estimated market size of US $1,584 million in the United States for the twelve months ending June 2026.
Company ANDA Approval Track Record
This approval brings Alembic's cumulative total to 248 ANDA approvals from the USFDA, consisting of 228 final approvals and 20 tentative approvals.
Company Background
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company that has been operating since 1907. The company manufactures and markets generic pharmaceutical products worldwide with state-of-the-art research and manufacturing facilities approved by regulatory authorities including the USFDA. In India, Alembic is one of the leaders in branded generics with a field force of over 5,800 representatives.