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Empagliflozin Patent Expiration

Empagliflozin is Used for reducing cardiovascular risk and treating type 2 diabetes, heart failure, and chronic kidney disease with empagliflozin. It was first introduced by Boehringer Ingelheim Pharmaceuticals Inc in its drug Jardiance on Aug 1, 2014. 3 different companies have introduced drugs containing Empagliflozin.


Empagliflozin Patents

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

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Country : United States (US)
Patent Category : All
Dosage Form Category : Others
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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Jardiance US9949998

(Pediatric)

 Pharmaceutical composition, methods for treating and uses thereof Dec 11, 2034 Boehringer Ingelheim
Jardiance US9949997

(Pediatric)

 Pharmaceutical composition, methods for treating and uses thereof Nov 17, 2034 Boehringer Ingelheim
Jardiance US10258637

(Pediatric)

 Pharmaceutical composition, methods for treating and uses thereof Oct 03, 2034 Boehringer Ingelheim
Jardiance US11090323

(Pediatric)

 Pharmaceutical composition, methods for treating and uses thereof Oct 03, 2034 Boehringer Ingelheim
Jardiance US11813275

(Pediatric)

 Pharmaceutical Composition, Methods For Treating And Uses Thereof Oct 03, 2034 Boehringer Ingelheim
Jardiance US11833166

(Pediatric)

 Pharmaceutical Composition, Methods For Treating And Uses Thereof Oct 03, 2034 Boehringer Ingelheim
Jardiance US12433906

(Pediatric)

 Pharmaceutical Composition, Methods For Treating And Uses Thereof Oct 03, 2034 Boehringer Ingelheim
Jardiance US9949998 Pharmaceutical composition, methods for treating and uses thereof Jun 11, 2034 Boehringer Ingelheim
Jardiance US9949997 Pharmaceutical composition, methods for treating and uses thereof May 17, 2034 Boehringer Ingelheim
Jardiance US10258637 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Jardiance US11090323 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Jardiance US11666590 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Jardiance US11813275 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Jardiance US11833166 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Jardiance US12263153 Pharmaceutical composition, methods for treating and uses thereof Apr 03, 2034 Boehringer Ingelheim
Jardiance US12427162 Pharmaceutical Composition, Methods For Treating And Uses Thereof Apr 03, 2034 Boehringer Ingelheim
Jardiance US12433906 Pharmaceutical Composition, Methods For Treating And Uses Thereof Apr 03, 2034 Boehringer Ingelheim
Jardiance US12527810

(Pediatric)

 Pharmaceutical Composition, Methods For Treating And Uses Thereof Oct 22, 2033 Boehringer Ingelheim
Jardiance US12527810 Pharmaceutical Composition, Methods For Treating And Uses Thereof Apr 22, 2033 Boehringer Ingelheim
Jardiance US12115179

(Pediatric)

 Pharmaceutical Composition, Methods For Treating And Uses Thereof Aug 11, 2030 Boehringer Ingelheim
Jardiance US10406172 Pharmaceutical composition, methods for treating and uses thereof Jun 15, 2030 Boehringer Ingelheim
Jardiance US8551957

(Pediatric)

 Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate Apr 14, 2030 Boehringer Ingelheim
Jardiance US12115179 Pharmaceutical composition, methods for treating and uses thereof Feb 11, 2030 Boehringer Ingelheim
Jardiance US8551957 Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate Oct 14, 2029 Boehringer Ingelheim
Jardiance US7579449

(Pediatric)

 Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Feb 01, 2029 Boehringer Ingelheim
Jardiance US7579449 Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture Aug 01, 2028 Boehringer Ingelheim
Jardiance US7713938

(Pediatric)

 Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments Oct 15, 2027 Boehringer Ingelheim
Jardiance US7713938 Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments Apr 15, 2027 Boehringer Ingelheim



Empagliflozin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Empagliflozin:

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. Empagliflozin has 1 clinical trial that has been verified in 2024.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus Inventiva Pharma NA COMPLETED
(Sep 1, 2026)
PHASE2
Empagliflozin in Patients With Cirrhosis and Ascites Yale University NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF) Colorado Prevention Center NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure Boehringer Ingelheim NA RECRUITING
(Sep 1, 2026)
PHASE3
Short-term Effects of an SGLT2 Inhibitor on Divalent Ions in Autosomal Dominant Polycystic Kidney Disease Cantonal Hospital Graubuenden NA COMPLETED
(Sep 1, 2026)
PHASE2
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) Boehringer Ingelheim NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease Boehringer Ingelheim NA COMPLETED
(Sep 1, 2026)
PHASE2
A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart Boehringer Ingelheim NA RECRUITING
(Sep 1, 2026)
PHASE3
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease Boehringer Ingelheim NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids) Boehringer Ingelheim NA RECRUITING
(Sep 1, 2026)
PHASE3
Cardioprotective Effect of Empagliflozin in Breast Cancer Patients Tanta University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD) NYU Langone Health NA COMPLETED
(Aug 1, 2026)
PHASE2
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Vanderbilt University Medical Center NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes University of Minnesota NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure Subodh Verma NA RECRUITING
(Aug 1, 2026)
PHASE3
Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure Christian Schulze NA RECRUITING
(Aug 1, 2026)
PHASE3
Vascular Effects of SGLT2i in Non-diabetic CKD VA Office of Research and Development NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Sodium/Glucose Cotransporter-2 Inhibitors (SGLT2i) Therapy in Duchenne Cardiomyopathy Vanderbilt University Medical Center NA RECRUITING
(Aug 1, 2026)
PHASE1
SGLTi, Hepatic Glucose Production and Ketogenesis The University of Texas Health Science Center at San Antonio NA RECRUITING
(Jul 1, 2026)
PHASE1
Polypill for Prevention of Cardiomyopathy University of Texas Southwestern Medical Center NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
The Role of SGLT2i in Management of Moderate AS University of East Anglia NA COMPLETED
(Jul 1, 2026)
PHASE2, PHASE3
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention Insel Gruppe AG, University Hospital Bern NA RECRUITING
(Jul 1, 2026)
PHASE3
Pioglitazone Versus Empagliflozin for Chronic Pancreatitis/Recurrent Acute Pancreatitis/Acute Pancreatitis Associated Diabetes Mellitus Mayo Clinic NA RECRUITING
(Jul 1, 2026)
PHASE2
Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension Gustavo A Heresi, MD, MS NA RECRUITING
(Jul 1, 2026)
PHASE2
SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia The University of Texas Health Science Center at San Antonio NA RECRUITING
(Jul 1, 2026)
PHASE1
SGLT2i, Pioglitazone, and Ketone Production in T2D The University of Texas Health Science Center at San Antonio NA RECRUITING
(Jul 1, 2026)
PHASE1
Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR 25 mg/5 mg/1000 mg Extended- Release Tablets Humanis Saglık Anonim Sirketi NA COMPLETED
(Jul 1, 2026)
PHASE1
Bioequivalence Study to Compare Empagliflozin/ Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg Humanis Saglık Anonim Sirketi NA COMPLETED
(Jul 1, 2026)
PHASE1
Timing of Empagliflozin in Primary PCI: Pre-Reperfusion Versus Post-Reperfusion Versus Placebo in South Asian STEMI Patients Rehman Medical Institute - RMI NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes Bayer NA COMPLETED
(Jun 1, 2026)
PHASE2
Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines Maria Sklodowska-Curie National Research Institute of Oncology NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
Effects of Acute and Chronic Empagliflozin Heart Failure Yale University NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE1
The Treatment Effects of Empagliflozin on Renal Outcomes in Cardiorenal Syndrome Type 1 Chulalongkorn University NA RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
New Triple Combination Therapy in Newly Diagnosed Type 2 Diabetes Sun Yat-sen University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Efficacy and Safety of Pioglitazone Combination Therapy in Type 2 Diabetes Patients on a Background of Empagliflozin With Metformin Celltrion NA COMPLETED
(May 1, 2026)
PHASE3
Targeting the Pathophysiology of Sickle Cell-Related Kidney Disease Using the SGLT2 Inhibitors, Empagliflozin University of Illinois at Chicago NA RECRUITING
(May 1, 2026)
PHASE2
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS) University Medical Center Groningen NA RECRUITING
(May 1, 2026)
PHASE2
Proteinuria in Normotensive Diabetic Patients: ARBs Alone or in Combination of SGLT2i Dr Mudassar Saeed Pansota NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2, PHASE3
SGLT2 Adjunct in T1D Ain Shams University NA COMPLETED
(May 1, 2026)
PHASE2, PHASE3
SGLT2i and KNO3 in HFpEF - The SAK HFpEF Trial University of Pennsylvania NA RECRUITING
(Apr 1, 2026)
PHASE2
Empagliflozin for No-reflow Phenomenon in PCI for STEMI Instituto Nacional de Cardiologia Ignacio Chavez NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF National Medical Research Center for Cardiology, Ministry of Health of Russian Federation NA RECRUITING
(Apr 1, 2026)
PHASE2
PRECISE Phenotyping to Guide Therapies for Coronary Microvascular Dysfunction King's College London NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3
Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes Mostafa Bahaa NA COMPLETED
(Mar 1, 2026)
PHASE2
Daily Use of JARDIANCE® Tablets in Japanese Elderly Patients With Type 2 Diabetes Mellitus Boehringer Ingelheim Eli Lilly and Company COMPLETED
(Feb, 2024)
Empagliflozin in Treatment of Peripheral Diabetic Neuropathy Tanta University NA COMPLETED
(Nov, 2023)
PHASE1, PHASE2
Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects. Chipscreen Biosciences, Ltd. NA COMPLETED
(Dec, 2022)
PHASE1
Effects of Empagliflozin on Cardiac Microvasculature and Insulin Sensitivity in Subjects With Type 2 Diabetes University of Virginia National Heart, Lung, and Blood Institute (NHLBI) UNKNOWN
(Feb, 2022)
EARLY PHASE1
A Study of Empagliflozin in Patients With Refractory Diabetes Mellitus With Insulin Resistance Kobe University Boehringer Ingelheim UNKNOWN
(Mar, 2021)
PHASE3
Empagliflozin on Cardiac-renal Injury in Patients With STEAMI Patients After Primary PCI Chinese PLA General Hospital NA UNKNOWN
(Jul, 2018)
NA
BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME). Boehringer Ingelheim Eli Lilly and Company COMPLETED
(Apr, 2016)
PHASE3
Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin Boehringer Ingelheim NA COMPLETED
(Jul, 2014)
PHASE1
BI 10773 Administered as Oral Solution to Healthy Male Volunteers Boehringer Ingelheim NA COMPLETED
(Jun, 2014)
PHASE1
Bioavailability of BI 10773 and Pioglitazone in Healthy Male Volunteers Boehringer Ingelheim NA COMPLETED
(May, 2014)
PHASE1


Empagliflozin Generic API Manufacturers

Several generic applications have been filed for Empagliflozin. The first generic version for Empagliflozin was by Zydus Pharmaceuticals Usa Inc and was approved on Aug 3, 2022. And the latest generic version is by Invagen Pharmaceuticals Inc and was approved on Sep 22, 2026.

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