Overview
- Alembic, Aurobindo, and Lupin disclosed final U.S. FDA approvals for dapagliflozin tablets on Tuesday, clearing them to market bioequivalent versions of AstraZeneca’s Farxiga.
- Biocon said in a separate statement that it also received FDA approval for dapagliflozin, adding another supplier to the field.
- The cleared tablets match Farxiga in 5 mg and 10 mg strengths for adults with type 2 diabetes and certain heart failure risks.
- Alembic and Aurobindo said they were early paragraph IV filers and qualify for 180 days of shared exclusivity, a U.S. rule that gives first generic challengers a head start.
- Aurobindo plans an immediate U.S. launch with production at APL Healthcare’s Unit‑IV, as companies target a market IQVIA estimates at about $10.2–$10.49 billion.