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-eight 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.
Annual sales in 2021 were $7.6bn, indicating a strong incentive for generic entry.
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
Summary for jardiance
International Patents: | 278 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 91 |
Clinical Trials: | 68 |
Patent Applications: | 686 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for jardiance |
Drug Sales Revenues: | Drug sales revenues for jardiance |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for jardiance |
What excipients (inactive ingredients) are in jardiance? | jardiance excipients list |
DailyMed Link: | jardiance at DailyMed |
Recent Clinical Trials for jardiance
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 2 |
University Health Network, Toronto | Phase 3 |
NYU Langone Health | Phase 2 |
Pharmacology for jardiance
Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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
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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
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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
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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
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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
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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
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NEW PATIENT POPULATION
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LABELING REVISIONS RELATED TO CLINICAL STUDIES
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PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
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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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Boehringer Ingelheim | JARDIANCE | empagliflozin | TABLET;ORAL | 204629-002 | Aug 1, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Boehringer Ingelheim | JARDIANCE | empagliflozin | TABLET;ORAL | 204629-001 | Aug 1, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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
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Patent: 7657
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Australia
Patent: 08288407
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Brazil
Patent: 0815331
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Canada
Patent: 96558
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Chile
Patent: 08002427
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China
Patent: 1784270
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Patent: 4288166
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Patent: 4353077
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Colombia
Patent: 51239
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Croatia
Patent: 0170022
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Cyprus
Patent: 18308
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Patent: 17017
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Denmark
Patent: 87879
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Ecuador
Patent: 109977
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Eurasian Patent Organization
Patent: 8608
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Patent: 1000321
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European Patent Office
Patent: 87879
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Patent: 98152
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Patent: 06156
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Patent: 39577
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Hong Kong
Patent: 01721
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Patent: 03351
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Hungary
Patent: 30158
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Patent: 700020
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Israel
Patent: 2886
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Japan
Patent: 95914
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Patent: 10535850
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Lithuania
Patent: 187879
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Patent: 2017014
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Patent: 87879
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Malaysia
Patent: 2037
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Mexico
Patent: 10001696
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Montenegro
Patent: 573
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Morocco
Patent: 612
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Netherlands
Patent: 0872
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New Zealand
Patent: 3242
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Norway
Patent: 17020
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Peru
Patent: 090938
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Poland
Patent: 87879
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Portugal
Patent: 87879
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Serbia
Patent: 205
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Slovenia
Patent: 87879
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South Africa
Patent: 0909105
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South Korea
Patent: 1491554
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Patent: 100049595
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Spain
Patent: 02748
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Taiwan
Patent: 72325
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Patent: 0914030
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Patent: 1436798
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Tunisia
Patent: 10000073
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Ukraine
Patent: 0384
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Uruguay
Patent: 296
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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 |
---|---|---|---|
Spain | 2702174 | ⤷ Sign Up | |
European Patent Office | 1888552 | FORME CRISTALLINE DE 1-CHLORO-4-(ß-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, SON PROCEDE DE PREPARATION ET SON UTILISATION DANS LA PREPARATION DE MEDICAMENTS (CRYSTALLINE FORM OF 1-CHLORO-4-(ß-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS) | ⤷ Sign Up |
Croatia | P20190101 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for jardiance
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1730131 | C01730131/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015 |
2187879 | CA 2017 00019 | Denmark | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115 |
2187879 | 20/2017 | Austria | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |