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Alembic Pharmaceuticals Secures USFDA Final Approval For $1.6 Billion Venetoclax With Exclusivity

30 October 2026
Alembic Pharmaceuticals Ltd.

Alembic received USFDA final approval for Venetoclax Tablets 10mg, 50mg and 100mg, generic of AbbVie's Venclexta for CLL/SLL and AML. As first ANDA filer with Paragraph IV, it may get 180-day exclusivity. IQVIA market size $1,584 million; cumulative ANDA approvals rise to 248.

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