FDA Approval and Launch of Multiple Generics to Farxiga
On April 7, 2026, the US Food and Drug Administration (FDA) approved several manufacturers’ AB-rated generics to AstraZeneca’s Farxiga® (dapagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. Farxiga is approved to reduce the risk of sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression; to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visit in adults with heart failure; to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and either established cardiovascular disease or multiple cardiovascular risk factors; and as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes. The recommended starting dose of Farxiga for glycemic control is 5mg once daily, which may be increased to 10mg once daily for additional glycemic control. The recommended dose for all other indications is 10mg once daily. Annual US sales for Farxiga are over $10 billion. While only Aurobindo has announced the launch of its generic, several more manufacturers are expected to launch their generics immediately as well.
At a Glance
- Brand Drug: Farxiga® (dapagliflozin)
- Manufacturer: AstraZeneca
- Generic Manufacturer(s): Ajanta, Alembic, Aurobindo, Cipla, Lupin, Macleods, Micro Labs and Zydus
- Indication: To reduce the risk of sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression; to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visit in adults with heart failure; to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes and either established cardiovascular disease or multiple cardiovascular risk factors; and as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes.
- Dosage Forms Available: 5mg and 10mg oral tablets
- Generic Launch Date: Some manufacturers have shared 180-day marketing exclusivity and are expected to launch their generics immediately.
- Annual US Sales: Estimated $10.2 billion for the 12 months ending February 2026, according to IQVIA data.
- Aurobindo stated its dapagliflozin tablets will be launched immediately.
- Other manufacturers have announced FDA approval but have not publicly disclosed US commercial launch dates.
- Prior to April 2026, dapaglifozin availability was limited to authorized generics marketed in the US by Prasco, A‑S Medication Solutions and Bryant Ranch Prepack. The April 2026 FDA actions approved additional AB‑rated Abbreviate New Drug Application (ANDA) generics from multiple manufacturers, expanding competition.