Alembic Pharmaceuticals Ltd receives USFDA final approval for generic Venetoclax Tablets in three strengths
- Approved strengths: 10 mg, 50 mg and 100 mg; therapeutically equivalent to AbbVie’s Venclexta for certain patients with CLL/SLL and AML.
- Alembic was a first ANDA applicant and may be eligible for 180 days of generic exclusivity.
- US market estimated at US$1.584 billion for the 12 months ended June 2026; Alembic has 248 cumulative USFDA ANDA approvals.