JARDIANCE Drug Patent Profile
✉ Email this page to a colleague
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 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 |
NYU Langone Health | Phase 2 |
American Society of Clinical Psychopharmacology | 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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
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
Patent: 17017
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 |
---|---|---|---|
China | 104906582 | Pharmaceutical composition comprising a SGLT2 inhibitor, a DPP-IV inhibitor and optionally a further antidiabetic agent and uses thereof | ⤷ Try a Trial |
Uruguay | 31296 | COMPOSICION FARMACÉUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO | ⤷ Try a Trial |
Austria | E407938 | ⤷ Try a Trial | |
Poland | 1888552 | ⤷ Try a Trial | |
Poland | 1730131 | ⤷ Try a Trial | |
Philippines | 12015502276 | THERAPEUTIC USES OF EMPAGLIFLOZIN | ⤷ Try a Trial |
Poland | 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 |
---|---|---|---|---|
2187879 | 17C1016 | France | ⤷ Try a Trial | PRODUCT NAME: COMBINAISON D'EMPAGLIFLOZINE ET DE LINAGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/16/1146 20161115 |
2187879 | 1790019-2 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF EMPAGLIFLOZIN AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1146 20161115 |
1730131 | C20140033 00134 | Estonia | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014 |
1730131 | 1490061-7 | Sweden | ⤷ Try a Trial | PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526 |
1730131 | 92555 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS,EN PARTICULIER EMPAGLIFLOZINE-L INGREDIENT ACTIF APPROUVE EST L EMPAGLIFLOZINE DE FORMULE(1S)-1,5-ANHYDRO-1-C-4-CHLORO-3-(4-(3S)OXOLAN-3-YLOXY PHENYL)METHYLPHENYL-D-GLUCITOL |
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 |
1730131 | 122014000099 | Germany | ⤷ Try a Trial | PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |