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Last Updated: March 29, 2024

jardiance Drug Patent Profile


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Which patents cover Jardiance, and what generic alternatives are available?

Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-seven patent family members in forty-five countries.

The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.

DrugPatentWatch® Generic Entry Outlook for Jardiance

Jardiance was eligible for patent challenges on August 1, 2018.

There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are thirteen tentative approvals for the generic drug (empagliflozin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for jardiance
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Drug Sales Revenue Trends for jardiance

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Recent Clinical Trials for jardiance

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SponsorPhase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2
University Health Network, TorontoPhase 3
NYU Langone HealthPhase 2

See all jardiance clinical trials

Pharmacology for jardiance
Paragraph IV (Patent) Challenges for JARDIANCE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JARDIANCE Tablets empagliflozin 10 mg and 25 mg 204629 14 2018-08-01

US Patents and Regulatory Information for jardiance

jardiance is protected by twelve US patents and six FDA Regulatory Exclusivities.

Patents protecting jardiance

Pharmaceutical composition, methods for treating and uses thereof
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Pharmaceutical composition, methods for treating and uses thereof
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Patented Use: TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN PATIENTS WITH HEART FAILURE AND TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION IN PATIENTS WITH HEART FAILURE BY ADMINISTRATION OF EMPAGLIFLOZIN


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Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND


Patent Number: ⤷  Try a Trial
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Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments
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Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
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Pharmaceutical composition, methods for treating and uses thereof
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Pharmaceutical composition, methods for treating and uses thereof
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FDA Regulatory Exclusivity protecting jardiance

REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE AND REDUCED EJECTION FRACTION
Exclusivity Expiration: ⤷  Try a Trial

USE OF EMPAGLIFLOZIN TO REDUCE THE RISK OF SUSTAINED DECLINE IN EGFR, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION
Exclusivity Expiration: ⤷  Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for jardiance

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Jardiance empagliflozin EMEA/H/C/002677
Type 2 diabetes mellitusJardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesFor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the annex.Heart failureJardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney diseaseJardiance is indicated in adults for the treatment of chronic kidney disease. 
Authorised no no no 2014-05-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for jardiance

When does loss-of-exclusivity occur for jardiance?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 7970
Estimated Expiration: ⤷  Try a Trial

Patent: 7657
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 08288407
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0815331
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 96558
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 08002427
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1784270
Estimated Expiration: ⤷  Try a Trial

Patent: 4288166
Estimated Expiration: ⤷  Try a Trial

Patent: 4353077
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 51239
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0170022
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18308
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 109977
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 8608
Estimated Expiration: ⤷  Try a Trial

Patent: 1000321
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

Patent: 98152
Estimated Expiration: ⤷  Try a Trial

Patent: 06156
Estimated Expiration: ⤷  Try a Trial

Patent: 39577
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 01721
Estimated Expiration: ⤷  Try a Trial

Patent: 03351
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 30158
Estimated Expiration: ⤷  Try a Trial

Patent: 700020
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2886
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 95914
Estimated Expiration: ⤷  Try a Trial

Patent: 10535850
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 187879
Estimated Expiration: ⤷  Try a Trial

Patent: 2017014
Estimated Expiration: ⤷  Try a Trial

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 2037
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10001696
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 573
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 612
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 0872
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 3242
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 17020
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 090938
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 205
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0909105
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1491554
Estimated Expiration: ⤷  Try a Trial

Patent: 100049595
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 02748
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 72325
Estimated Expiration: ⤷  Try a Trial

Patent: 0914030
Estimated Expiration: ⤷  Try a Trial

Patent: 1436798
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 10000073
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 0384
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 296
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering jardiance around the world.

Country Patent Number Title Estimated Expiration
Singapore 151271 GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF ⤷  Try a Trial
Canada 2587639 DERIVES DE BENZENE SUBSTITUES PAR GLUCOPYRANOSYLE, MEDICAMENTS CONTENANT CES COMPOSES, LEUR UTILISATION ET LEUR PROCEDE DE FABRICATION (GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVES, MEDICAMENTS CONTAINING SUCH COMPOUNDS, THEIR USE AND PROCESS FOR THEIR MANUFACTURE) ⤷  Try a Trial
European Patent Office 2981271 USAGES THÉRAPEUTIQUES D'EMPAGLIFLOZINE (THERAPEUTIC USES OF EMPAGLIFLOZIN) ⤷  Try a Trial
New Zealand 711661 Therapeutic uses of empagliflozin ⤷  Try a Trial
China 110075301 依帕列净的治疗用途 (Therapeutic uses of empagliflozin) ⤷  Try a Trial
Peru 20091588 DERIVADOS DE BENCENO SUSTITUIDOS POR GLUCOPIRANOSILO, MEDICAMENTOS QUE CONTIENEN ESOS COMPUESTOS, SU APLICACION Y PROCEDIMIENTOS PARA SU PREPARACION ⤷  Try a Trial
Lithuania 2981255 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for jardiance

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 122014000099 Germany ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
2187879 SPC/GB17/031 United Kingdom ⤷  Try a Trial PRODUCT NAME: 1-CHLORO-4-(SS-D-GLUCOPYRANOS-1-YL)-2-(4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL)-BENZENE (I.E. EMPAGLIFLOZIN) IN COMBINATION WITH 1-((4 METHYL-QUINAZOLIN-2-YL)METHYL)-3-METHYL-7-(2-BUTYN-1-YL)-8-(3-(R)-AMINO-PIPERIDIN-1-YL)-XANTHINE (I.E. LINAGLIPTIN) OR A P; REGISTERED: UK PLGB 14598/0191 (GB) 20161115; UK EU/1/16/1146/014(NI) 20161115; UK EU/1/16/1146/015(NI) 20161115; UK EU/1/16/1146/016(NI) 20161115; UK EU/1/16/1146/017(NI) 20161115; UK EU/1/16/1146/018(NI) 20161115; UK EU/1/16/1146/007(NI) 20161115; UK EU/1/16/1146/001(NI) 20161115; UK EU/1/16/1146/013(NI) 20161115; UK EU/1/16/1146/002(NI) 20161115; UK EU/1/16/1146/003(NI) 20161115; UK EU/1/16/1146/004(NI) 20161115; UK...
2187879 20/2017 Austria ⤷  Try a Trial PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115
2187879 2017/018 Ireland ⤷  Try a Trial PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111
1730131 2014/055 Ireland ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131 PA2014035,C1730131 Lithuania ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
2187879 276 10-2017 Slovakia ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN/LINAGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1146 20161115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.