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Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and twenty-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.
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 2018 were $1.7bn, indicating a strong incentive for generic entry.
There have been five 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 four tentative approvals for the generic drug (empagliflozin), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for JARDIANCE
|Finished Product Suppliers / Packagers:||4|
|Raw Ingredient (Bulk) Api Vendors:||75|
|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|
DrugPatentWatch® Estimated Generic Entry Opportunity Date for JARDIANCE
*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
|University Hospital, Basel, Switzerland||Phase 4|
|Applied Health Research Centre||Phase 4|
|Canadian Medical and Surgical Knowledge Translation Research Group||Phase 4|
Pharmacology for JARDIANCE
|Country||Patent Number||Estimated Expiration|
|Montenegro||01173||Get Started Free|
|Eurasian Patent Organization||201101191||Get Started Free|
|European Patent Office||2360164||Get Started Free|
|Japan||2016515600||Get Started Free|
|Lithuania||2187879||Get Started Free|
|Argentina||048041||Get Started Free|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|2187879||LUC00017||Luxembourg||Get Started Free||PRODUCT NAME: GLYXAMBI- EMPAGLIFLOZINE/LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1146 20161115|
|2187879||PA2017014,C2187879||Lithuania||Get Started Free||PRODUCT NAME: EMPAGLIFLOZINO IR LINAGLIPTINO ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/16/1146/001 - EU/1/16/1146/018 20161111|
|2187879||132017000050485||Italy||Get Started Free||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||92555||Luxembourg||Get Started Free||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|
|1730131||CR 2014 00054||Denmark||Get Started Free||PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527|
|1730131||C01730131/03||Switzerland||Get Started Free||PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|