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. 2 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.

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 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 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 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
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 COMPLETED
(Nov, 2023)
PHASE1, PHASE2
Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects. Chipscreen Biosciences, Ltd. 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 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 COMPLETED
(Jul, 2014)
PHASE1
BI 10773 Administered as Oral Solution to Healthy Male Volunteers Boehringer Ingelheim COMPLETED
(Jun, 2014)
PHASE1
Bioavailability of BI 10773 and Pioglitazone in Healthy Male Volunteers Boehringer Ingelheim COMPLETED
(May, 2014)
PHASE1


Empagliflozin Generic API Manufacturers

Several generic applications have been filed for Empagliflozin.

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


1. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Empagliflozin. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Discontinued ORAL N/A Aug 3, 2022
25MG

tablet Discontinued ORAL N/A Aug 3, 2022