Aurobindo Pharma wins US FDA approval, launches generic Xigduo XR
Business
Aurobindo Pharma just got the go-ahead from the US Food and Drug Administration to launch a generic version of Xigduo XR, a popular diabetes medication.
Their new tablets, dapagliflozin and metformin hydrochloride extended-release, will be made in-house and are hitting the market right away, offering another option for people managing type 2 diabetes.
Aurobindo secures 180-day US exclusivity
This drug helps control blood sugar when paired with healthy habits, and its US market is worth about $514 million (as of February 2026).
Aurobindo also scored a 180-day exclusivity window since it was among the first to file, a pretty big win.
With this approval, Aurobindo now has 579 ANDA approvals from the USFDA, showing how much it has grown in the pharma world.