Alembic Pharmaceuticals received USFDA final approval for generic Dapagliflozin Tablets 5mg and 10mg.
The approval includes 180-day shared exclusivity as first ANDA applicant with paragraph IV certification.
Dapagliflozin has estimated market size of $10.5 billion for twelve months ending December 2025.
Company now has cumulative total of 235 ANDA approvals from USFDA (217 final, 18 tentative).