Latest signals
What changed
The three most recent source-backed changes linked to this drug.
DiabetesDrug intelligence
Farxiga
Dapagliflozin
SGLT2 inhibitor. Developed by AstraZeneca. Clinical, regulatory, and source evidence are connected below.
- Company
- AstraZeneca
- Target / MOA
- SGLT2 · SLC5A2
- Aliases
- Farxiga · Forxiga · Edistride
- Signals
- 40
- Clinical trials
- 18
- Approvals
- 15
- Evidence sources
- 40
Approved uses
What regulators have approved
The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.
United States (FDA label)
Label section 1
1 INDICATIONS AND USAGE FARXIGA (dapagliflozin) is indicated: • To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. • To reduce the risk of CV 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 mellitus and either established CV disease or multiple CV risk factors. • 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 mellitus. Limitations of Use • FARXIGA is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1) ] . • FARXIGA is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . FARXIGA is likely to be ineffective in this setting based upon its mechanism of action. • FARXIGA is not recommended for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of immunosuppressive therapy for kidney disease. FARXIGA is not expected to be effective in these populations.
European Union (EMA)
Type 2 diabetes mellitus Forxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Forxiga is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Forxiga is indicated in adults for the treatment of chronic kidney disease.
Type 2 diabetes mellitus Edistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance. in addition to other medicinal products for the treatment of type 2 diabetes. For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failure Edistride is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney disease Edistride is indicated in adults for the treatment of chronic kidney disease.
EMA's summary; the full indication is in the product information on the EPAR page.
Not covered here: Xigduo XR, Qtern and Qternmet XR (US); Xigduo, Ebymect and Qtern (EU) (Combinations with other diabetes drugs; combination products are not covered yet.)
Regulatory history
Approvals over time
US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.
United States
8 efficacy supplements approved
- Jun 12, 2024 · supplement 31
- May 8, 2023 · supplement 26
- Apr 30, 2021 · supplement 24
- May 5, 2020 · supplement 20
- Oct 18, 2019 · supplement 18
- Feb 22, 2019 · supplement 15
- Oct 20, 2017 · supplement 12
- Mar 11, 2015 · supplement 2
European Union
- Forxiga: Authorised since Nov 12, 2012
- Edistride: Authorised since Nov 9, 2015
Patents and exclusivity
What FDA lists (US)
Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.
NDA202293 (Orange Book)
30 listed patents, latest expiry Oct 1, 2041
- US 8329648*PED · expires Feb 18, 2027 · no claim type flagged
- US 8906851*PED · expires Feb 18, 2027 · no claim type flagged
- US 8501698 · expires Jun 20, 2027 · drug product, U-493
- US 8501698*PED · expires Dec 20, 2027 · no claim type flagged
- US 8221786 · expires Mar 21, 2028 · drug product
- US 8361972 · expires Mar 21, 2028 · U-2139, U-493
- US 8716251 · expires Mar 21, 2028 · drug product
- US 7851502 · expires Aug 19, 2028 · drug product
- US 8221786*PED · expires Sep 21, 2028 · no claim type flagged
- US 8361972*PED · expires Sep 21, 2028 · no claim type flagged
- US 8716251*PED · expires Sep 21, 2028 · no claim type flagged
- US 7851502*PED · expires Feb 19, 2029 · no claim type flagged
- US 7919598 · expires Dec 16, 2029 · drug substance
- US 8721615 · expires Jan 18, 2030 · drug product
- US 8685934 · expires May 26, 2030 · U-1522
- US 7919598*PED · expires Jun 16, 2030 · no claim type flagged
- US 8721615*PED · expires Jul 18, 2030 · no claim type flagged
- US 8685934*PED · expires Nov 26, 2030 · no claim type flagged
- US 11826376 · expires Jul 18, 2039 · U-3766 · listed for some products only: FARXIGA 10MG
- US 12472194 · expires Jul 18, 2039 · U-4346 · listed for some products only: FARXIGA 10MG
- US 11826376*PED · expires Jan 18, 2040 · no claim type flagged · listed for some products only: FARXIGA 10MG
- US 12472194*PED · expires Jan 18, 2040 · no claim type flagged · listed for some products only: FARXIGA 10MG
- US 10973836 · expires Mar 9, 2040 · U-3127 · listed for some products only: FARXIGA 10MG
- US 11903955 · expires Mar 9, 2040 · U-3825 · listed for some products only: FARXIGA 10MG
- US 10973836*PED · expires Sep 9, 2040 · no claim type flagged · listed for some products only: FARXIGA 10MG
- US 11903955*PED · expires Sep 9, 2040 · no claim type flagged · listed for some products only: FARXIGA 10MG
- US 12213988 · expires Apr 1, 2041 · U-4140 · listed for some products only: FARXIGA 10MG
- US 12409186 · expires Apr 1, 2041 · U-4140 · listed for some products only: FARXIGA 10MG
- US 12213988*PED · expires Oct 1, 2041 · no claim type flagged · listed for some products only: FARXIGA 10MG
- US 12409186*PED · expires Oct 1, 2041 · no claim type flagged · listed for some products only: FARXIGA 10MG
Generics and biosimilars
15 approved generics (ANDA)
- AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD · ANDA211523 · approved Apr 6, 2026
- AJANTA PHARMA LTD · ANDA211482 · approved Apr 6, 2026
- ALEMBIC PHARMACEUTICALS LTD · ANDA211560 · approved Apr 6, 2026
- ALKEM LABORATORIES LTD · ANDA211545 · approved Apr 6, 2026
- AUROBINDO PHARMA LTD · ANDA211468 · approved Apr 6, 2026
- BIOCON PHARMA LTD · ANDA211470 · approved Apr 6, 2026
- CIPLA LTD · ANDA211535 · approved Apr 6, 2026
- INVENTIA HEALTHCARE LTD · ANDA211156 · approved Apr 6, 2026
- LUPIN LTD · ANDA211531 · approved Apr 6, 2026
- MACLEODS PHARMACEUTICALS LTD · ANDA211506 · approved Apr 6, 2026
- MICRO LABS LTD · ANDA211467 · approved Apr 6, 2026
- MSN LABORATORIES PRIVATE LTD · ANDA211478 · approved Apr 6, 2026
- SANDOZ INC · ANDA211312 · approved Apr 6, 2026
- TEVA PHARMACEUTICALS USA INC · ANDA211541 · approved Apr 6, 2026
- ZYDUS PHARMACEUTICALS USA INC · ANDA211582 · approved Apr 6, 2026
*PED is FDA's mark for a patent's period extended by six months of pediatric exclusivity.
FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.
Safety
Boxed warnings and FDA safety communications
The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.
Boxed warning
The current US label has no boxed warning.
FDA Drug Safety Communications
None on FDA's list names this drug.
Clinical trials
Key active studies
A focused view of recently updated studies · 18 linked records.
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
AstraZeneca · Updated Oct 21, 2026
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
University Medical Center Groningen · Updated Oct 20, 2026
Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
Oslo University Hospital · Updated Oct 20, 2026
Study of the Effect of Haemodialysis on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone/Dapagliflozin
AstraZeneca · Updated Oct 20, 2026
Effect of Dapagliflozin on Metabolic Parameters in Patients With Non-Alcoholic Fatty Liver Disease
Shalamar Hospital · Updated Oct 19, 2026
A Study of Orforglipron (LY3502970) Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin
Eli Lilly and Company · Updated Oct 16, 2026
Regulatory timeline
Approvals and agency activity
Verified regulatory records in reverse chronological order.
Related intelligence
Connected drugs
Records connected through the current intelligence graph.
Source evidence
Where this profile comes from
Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.