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Last Updated: August 8, 2022

JARDIANCE Drug Patent Profile


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When do Jardiance patents expire, and what generic alternatives are available?

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

This drug has two hundred and thirty-two patent family members in forty-four 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 14, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $3.4bn, indicating a strong incentive for generic entry.

There have been fourteen 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 eight 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
Drug Prices for JARDIANCE

See drug prices for JARDIANCE

Drug Sales Revenue Trends for JARDIANCE

See drug sales revenues for JARDIANCE

DrugPatentWatch® Estimated Generic Entry Opportunity Date for JARDIANCE
Generic Entry Date for JARDIANCE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for JARDIANCE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Polish Medical Research AgencyPhase 3
Maria Sklodowska-Curie National Research Institute of OncologyPhase 3
Oregon State UniversityPhase 4

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 nine US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JARDIANCE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting JARDIANCE

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH PLUS HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS, HEART FAILURE AND REDUCED EJECTION FRACTION BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND HEART FAILURE BY ONCE DAILY ADMINISTRATION OF EMPAGLIFLOZIN

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF REDUCING THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND CARDIOVASCULAR DISEASE BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2

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: See Plans and Pricing

LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: See Plans and Pricing

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 204629-001 Aug 1, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-002 Aug 1, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim JARDIANCE empagliflozin TABLET;ORAL 204629-001 Aug 1, 2014 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 exercise - as monotherapy when metformin is considered inappropriate due to intolerance - in addition to other medicinal products for the treatment of diabetes For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. Heart failureJardiance is indicated in adults for the treatment of symptomatic chronic heart failure.
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: See Plans and Pricing

Patent: 7657
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08288407
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0815331
Estimated Expiration: See Plans and Pricing

Canada

Patent: 96558
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08002427
Estimated Expiration: See Plans and Pricing

China

Patent: 1784270
Estimated Expiration: See Plans and Pricing

Patent: 4288166
Estimated Expiration: See Plans and Pricing

Patent: 4353077
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 51239
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0170022
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18308
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 87879
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 109977
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8608
Estimated Expiration: See Plans and Pricing

Patent: 1000321
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 87879
Estimated Expiration: See Plans and Pricing

Patent: 98152
Estimated Expiration: See Plans and Pricing

Patent: 06156
Estimated Expiration: See Plans and Pricing

Patent: 39577
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 01721
Estimated Expiration: See Plans and Pricing

Patent: 03351
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 30158
Estimated Expiration: See Plans and Pricing

Patent: 700020
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2886
Estimated Expiration: See Plans and Pricing

Japan

Patent: 95914
Estimated Expiration: See Plans and Pricing

Patent: 10535850
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 187879
Estimated Expiration: See Plans and Pricing

Patent: 2017014
Estimated Expiration: See Plans and Pricing

Patent: 87879
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 2037
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10001696
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 573
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 612
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0872
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3242
Estimated Expiration: See Plans and Pricing

Norway

Patent: 17020
Estimated Expiration: See Plans and Pricing

Peru

Patent: 090938
Estimated Expiration: See Plans and Pricing

Poland

Patent: 87879
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 87879
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 205
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 87879
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0909105
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1491554
Estimated Expiration: See Plans and Pricing

Patent: 100049595
Estimated Expiration: See Plans and Pricing

Spain

Patent: 02748
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 72325
Estimated Expiration: See Plans and Pricing

Patent: 0914030
Estimated Expiration: See Plans and Pricing

Patent: 1436798
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000073
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 0384
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 296
Estimated Expiration: See Plans and Pricing

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
Hong Kong 1203351 包含吡喃葡萄糖基-取代的苯衍生物的藥物組合物 (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL SUBSTITUTED BENZENE DERIVATIVE) See Plans and Pricing
South Korea 102318207 See Plans and Pricing
European Patent Office 2395983 COMPOSITION PHARMACEUTIQUE CONTENANT UN INHIBITEUR SGLT2 EN COMBINAISON AVEC UN INHIBITEUR DPP-IV ET OPTIOENELLEMENT UN AUTRE AGENT ANTIDIABETIQUE (PHARMACEUTICAL COMPOSITION COMPRISNG A SGLT2 INHIBITOR, A DPP-IV INHIBITOR AND OPTIONALLY A FURTHER ANTIDIABETIC AGENT AND USES THEREOF) See Plans and Pricing
Poland 1888552 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JARDIANCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2187879 122017000024 Germany See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN MIT LINAGLIPTIN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ HIERVON; REGISTRATION NO/DATE: EU/1/16/1146/001-018 20161111
2187879 SPC/GB17/031 United Kingdom See Plans and Pricing 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 132017000050485 Italy See Plans and Pricing PRODUCT NAME: COMBINAZIONE DI EMPAGLIFLOZIN E LINAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GLYXAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1146, 20161115
1730131 CR 2014 00054 Denmark See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527
>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.