Dapagliflozin Patent Expiration

Dapagliflozin is used for treating heart failure and type 2 diabetes. It was first introduced by Astrazeneca Ab in its drug Farxiga on Jan 8, 2014. 16 different companies have introduced drugs containing Dapagliflozin.


Dapagliflozin Patents

Given below is the list of patents protecting Dapagliflozin, along with the drug name that holds that patent and the company name owning that drug.

Filter patents by

NEW
Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Farxiga US12213988

(Pediatric)

Methods Of Treating Chronic Kidney Disease With Dapagliflozin Oct 01, 2041 Astrazeneca Ab
Farxiga US12409186

(Pediatric)

Methods Of Treating Chronic Kidney Disease With Dapagliflozin Oct 01, 2041 Astrazeneca Ab
Farxiga US12213988 Methods of treating chronic kidney disease with dapagliflozin Apr 01, 2041 Astrazeneca Ab
Farxiga US12409186 Methods Of Treating Chronic Kidney Disease With Dapagliflozin Apr 01, 2041 Astrazeneca Ab
Farxiga US10973836

(Pediatric)

Methods of treating heart failure with reduced ejection fraction Sep 09, 2040 Astrazeneca Ab
Farxiga US11903955

(Pediatric)

Methods of treating heart failure with reduced ejection fraction Sep 09, 2040 Astrazeneca Ab
Farxiga US10973836 Methods of treating heart failure with reduced ejection fraction Mar 09, 2040 Astrazeneca Ab
Farxiga US11903955 Methods of treating heart failure with reduced ejection fraction Mar 09, 2040 Astrazeneca Ab
Farxiga US11826376

(Pediatric)

Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same Jan 18, 2040 Astrazeneca Ab
Farxiga US12472194

(Pediatric)

Methods Of Treating Heart Failure With Preserved Ejection Fraction Employing Dapagliflozin And Compositions Comprising The Same Jan 18, 2040 Astrazeneca Ab
Farxiga US11826376 Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same Jul 18, 2039 Astrazeneca Ab
Farxiga US12472194 Methods Of Treating Heart Failure With Preserved Ejection Fraction Employing Dapagliflozin And Compositions Comprising The Same Jul 18, 2039 Astrazeneca Ab
Farxiga US8685934

(Pediatric)

Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof Nov 26, 2030 Astrazeneca Ab
Farxiga US8721615

(Pediatric)

Ampoule comprising an ampoule holder Jul 18, 2030 Astrazeneca Ab
Farxiga US7919598

(Pediatric)

Crystal structures of SGLT2 inhibitors and processes for preparing same Jun 16, 2030 Astrazeneca Ab
Farxiga US8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof May 26, 2030 Astrazeneca Ab
Farxiga US8721615 Ampoule comprising an ampoule holder Jan 18, 2030 Astrazeneca Ab
Farxiga US7919598 Crystal structures of SGLT2 inhibitors and processes for preparing same Dec 16, 2029 Astrazeneca Ab
Farxiga US7851502

(Pediatric)

Pharmaceutical formulations containing an SGLT2 inhibitor Feb 19, 2029 Astrazeneca Ab
Farxiga US8221786

(Pediatric)

Pharmaceutical formulations containing an SGLT2 inhibitor Sep 21, 2028 Astrazeneca Ab
Farxiga US8361972

(Pediatric)

Pharmaceutical formulations containing an SGLT2 inhibitor Sep 21, 2028 Astrazeneca Ab
Farxiga US8716251

(Pediatric)

Pharmaceutical formulations containing an SGLT2 inhibitor Sep 21, 2028 Astrazeneca Ab
Farxiga US7851502 Pharmaceutical formulations containing an SGLT2 inhibitor Aug 19, 2028 Astrazeneca Ab
Farxiga US8221786 Pharmaceutical formulations containing an SGLT2 inhibitor Mar 21, 2028 Astrazeneca Ab
Farxiga US8361972 Pharmaceutical formulations containing an SGLT2 inhibitor Mar 21, 2028 Astrazeneca Ab
Farxiga US8716251 Pharmaceutical formulations containing an SGLT2 inhibitor Mar 21, 2028 Astrazeneca Ab
Farxiga US8501698

(Pediatric)

Crystal structures of SGLT2 inhibitors and processes for preparing same Dec 20, 2027 Astrazeneca Ab
Farxiga US8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same Jun 20, 2027 Astrazeneca Ab
Farxiga US8329648

(Pediatric)

Methods for treating diabetes and reducing body weight Feb 18, 2027 Astrazeneca Ab
Farxiga US8906851

(Pediatric)

Method for treating diabetes Feb 18, 2027 Astrazeneca Ab
Farxiga US8329648 Methods for treating diabetes and reducing body weight Aug 18, 2026

(Expired)

Astrazeneca Ab
Farxiga US8906851 Method for treating diabetes Aug 18, 2026

(Expired)

Astrazeneca Ab
Farxiga US6515117

(Pediatric)

C-aryl glucoside SGLT2 inhibitors and method Apr 04, 2026

(Expired)

Astrazeneca Ab
Farxiga US7456254

(Pediatric)

Polymer-based sustained release device Dec 30, 2025

(Expired)

Astrazeneca Ab
Farxiga US8431685

(Pediatric)

Polymer-based sustained release device Oct 13, 2025

(Expired)

Astrazeneca Ab
Farxiga US8461105

(Pediatric)

Polymer-based sustained release device Oct 13, 2025

(Expired)

Astrazeneca Ab
Farxiga US6515117 C-aryl glucoside SGLT2 inhibitors and method Oct 04, 2025

(Expired)

Astrazeneca Ab
Farxiga US7456254 Polymer-based sustained release device Jun 30, 2025

(Expired)

Astrazeneca Ab
Farxiga US8431685 Polymer-based sustained release device Apr 13, 2025

(Expired)

Astrazeneca Ab
Farxiga US8461105 Polymer-based sustained release device Apr 13, 2025

(Expired)

Astrazeneca Ab
Farxiga US9238076 Polymer-based sustained release device Apr 15, 2024

(Expired)

Astrazeneca Ab
Farxiga US6414126 C-aryl glucoside SGLT2 inhibitors and method Oct 04, 2020

(Expired)

Astrazeneca Ab
Farxiga US6936590 C-aryl glucoside SGLT2 inhibitors and method Oct 04, 2020

(Expired)

Astrazeneca Ab
Farxiga US9198925 Pharmaceutical formulations containing an SGLT2 inhibitor Oct 04, 2020

(Expired)

Astrazeneca Ab



Dapagliflozin's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List



Clinical Trials

Recent Clinical Trials on Dapagliflozin:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE3
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE3
The Food Effect on Pharmacokinetics of Fixed Dose Combination of Gemigliptin/Dapagliflozin/Metformin in Healthy Volunteers LG Chem NA COMPLETED
(Sep 1, 2026)
PHASE1
Regression in Left Ventricular Hypertrophy and Fibrosis in Aortic Stenosis University College, London NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD) AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE3
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease. AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE3
Study of the Effect of Haemodialysis on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone/Dapagliflozin AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF AstraZeneca NA RECRUITING
(Sep 1, 2026)
PHASE3
Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome Tanta University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria) AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Sodium-Glucose Cotransporter-2 Inhibitor for Acute Cardiorenal Syndrome: A Feasibility Study Yale University NA COMPLETED
(Aug 1, 2026)
PHASE2
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure AstraZeneca NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Generic Drugs (Dapagliflozin and Saxagliptin) Treat Type 2 Diabetes Patients With Controlled Cancers Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure. AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
HFrEF Polypill in Sri Lanka RCT Washington University School of Medicine NA RECRUITING
(Aug 1, 2026)
PHASE3
A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus AstraZeneca NA RECRUITING
(Aug 1, 2026)
PHASE3
A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus AstraZeneca NA RECRUITING
(Aug 1, 2026)
PHASE3
Effects of Berberine Ursodeoxycholate (HTD1801) Versus Dapagliflozin in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Shenzhen HighTide Biopharmaceutical Ltd. NA COMPLETED
(Jul 1, 2026)
PHASE3
The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children Children's Hospital of Fudan University NA RECRUITING
(Jul 1, 2026)
PHASE3
SGLT2i, Pioglitazone, and Ketone Production in T1D The University of Texas Health Science Center at San Antonio NA RECRUITING
(Jul 1, 2026)
PHASE3
STOP-PKD: SGLT2-inhibition to Improve Prognosis in Polycystic Kidney Disease University of Cologne NA RECRUITING
(Jul 1, 2026)
PHASE3
A Clinical Study in Healthy Adults to See How the Body Processes and How Safe a Tablet That Combines Gemigliptin, Dapagliflozin, and Metformin is, Compared With Taking Zemiglo and Xigduo XR Together While Fasting. LG Chem NA COMPLETED
(Jul 1, 2026)
PHASE1
Dapagliflozin Add-on in Unresectable HCC With Metabolic Syndrome Sun Yat-sen University NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
aDAPt-ANOCA: Dapagliflozin for the Treatment of Angina With Non-Obstructive Coronary Artery Disease (ANOCA) The Christ Hospital NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Neoadjuvant SGLT2 Inhibition in Localized Prostate Cancer Washington University School of Medicine NA TERMINATED
(Jun 1, 2026)
PHASE1
DapagliFLOzin in Renal AL Amyloidosis (FLORAL) Barbara Ann Karmanos Cancer Institute NA RECRUITING
(Jun 1, 2026)
PHASE2
Dapagliflozin to Prevent Anthracycline-Induced Cardiotoxicity Hawler Medical University NA COMPLETED
(Jun 1, 2026)
PHASE2
Dapagliflozin for Long COVID Syndrome Ottawa Heart Institute Research Corporation NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Impact of Dapagliflozin for the Regulation of Immunological Activity in Membranous Nephropathy Centre Hospitalier Universitaire de Nice NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
SGLT2 Inhibitors in Adult Primary Nephrotic Syndrome Mansoura University NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
"Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial" Beni-Suef University NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Effects of SGLT2 Inhibition on Myocardial Insulin Sensitivity Giaccari Andrea NA COMPLETED
(May 1, 2026)
PHASE3
Triple Therapy in T1DM State University of New York at Buffalo NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2, PHASE3
The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD University Medical Center Groningen NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE3
Efficacy and Safety of Lorundrostat in Addition to Sodium-Glucose Cotransporter-2 Inhibitors (SGLT2i) in Subjects With Hypertension and Chronic Kidney Disease (CKD) With Albuminuria Mineralys Therapeutics Inc. NA COMPLETED
(May 1, 2026)
PHASE2
A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. AstraZeneca NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome Beni-Suef University NA COMPLETED
(May 1, 2026)
PHASE3
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation Mayo Clinic NA RECRUITING
(May 1, 2026)
PHASE2
A Study to Evaluate Efficacy and Safety of HM11260C in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin Hanmi Pharmaceutical Company Limited NA RECRUITING
(May 1, 2026)
PHASE3
A Study to Compare the Pharmacokinetics and Safety of the ATB-U101 and ATB-U1011+ATB-U1012 and ATB-1011+ATB-1012 in Healthy Caucasian Participants Autotelicbio NA NOT YET RECRUITING
(May 1, 2026)
PHASE1
"Dapagliflozin vs Dapagliflozin-Finerenone for Albuminuria in CKD With Type 2 Diabetes" Chittagong Medical College NA NOT YET RECRUITING
(May 1, 2026)
PHASE3
Effects of Dapagliflozin, Semaglutide, and Their Combination in Heart Failure Patients With Prosthetic Heart Valves Kafrelsheikh University NA COMPLETED
(May 1, 2026)
PHASE2
Efficacy, Mechanisms and Safety of SGLT2 Inhibitors in Kidney Transplant Recipients University Health Network, Toronto NA COMPLETED
(Apr 1, 2026)
PHASE3
A Study to Investigate the Mechanistic Effects of Dapagliflozin Alone or in Combination With Balcinrenone, Compared to Balcinrenone and Placebo on Body Fluid and Electrolyte Handling and Energy Metabolism in Participants Over 50 Years of Age With Chronic Kidney Disease. Klinikum Nürnberg NA COMPLETED
(Apr 1, 2026)
PHASE2
The Efficacy, Mechanism & Safety of Sodium Glucose Co-Transporter-2 Inhibitor & Glucagon-Like Peptide 1 Receptor Agonist Combination Therapy in Kidney Transplant Recipients University Health Network, Toronto NA RECRUITING
(Apr 1, 2026)
PHASE2
The Impact Of SGLT2 -I on Metabolic Dysfunction -Associated Steatotic Liver Disease In Patients With Type 2 Diabetes Mellitus Sohag University NA COMPLETED
(Apr 1, 2026)
PHASE3
Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity Tanta University NA RECRUITING
(Apr 1, 2026)
PHASE2
A Study to Investigate the Concentrations of Zibotentan and Dapagliflozin in Blood When Given With and Without Food AstraZeneca NA COMPLETED
(Apr 1, 2026)
PHASE1
Dapagliflozin for Anemia in Lower-Risk Myelodysplastic Syndromes Seug yun Yoon, MD NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Dapagliflozin in Living-Donor Kidney Transplant Recipients University of Guadalajara NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy Travere Therapeutics, Inc. NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE3
Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF) University of Oklahoma NA RECRUITING
(Mar 1, 2026)
PHASE3
Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome Yale University NA RECRUITING
(Mar 1, 2026)
PHASE2
SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism Huashan Hospital NA RECRUITING
(Mar 1, 2026)
PHASE2
Assessing the Efficacy of Dapagliflozin as a Vasculoprotective Treatment in Septic Shock Patients With Microcirculatory Dysfunction University Hospital, Strasbourg, France NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE3


Dapagliflozin Generic API Manufacturers

Several generic applications have been filed for Dapagliflozin. The first generic version for Dapagliflozin was by Inventia Healthcare Ltd and was approved on Apr 6, 2026. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Apr 6, 2026.

Given below is the list of companies who have filed for Dapagliflozin generic, along with the locations of their manufacturing plants worldwide.


Dapagliflozin News

AstraZeneca and Sun Resolve Patent Disputes Concerning Three Diabetes Medications - Bloomberg Law News

09 Apr, 2026

AstraZeneca's legal victory puts a stop to a more affordable diabetes medication - | National News

16 Feb, 2026

AstraZeneca's court victory puts a stop to a lower-cost diabetes medication - AAP News

16 Feb, 2026

AstraZeneca's court victory puts a stop to a more affordable diabetes medication - Yahoo News Australia

16 Feb, 2026

See More