➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
Moodys
AstraZeneca
Medtronic
McKesson

Last Updated: June 16, 2021

DrugPatentWatch Database Preview

JARDIANCE Drug Profile


Email this page to a colleague

« Back to Dashboard

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 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.

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 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

< Available with Subscription >

  Get Started Free

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
University Hospital, Basel, SwitzerlandPhase 4
Applied Health Research CentrePhase 4
Canadian Medical and Surgical Knowledge Translation Research GroupPhase 4

See all JARDIANCE clinical trials

Pharmacology for JARDIANCE
Paragraph IV (Patent) Challenges for JARDIANCE
Tradename Dosage Ingredient NDA Submissiondate
JARDIANCE TABLET;ORAL empagliflozin 204629 2018-08-01

US Patents and Regulatory Information for JARDIANCE

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

Supplementary Protection Certificates for JARDIANCE

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Colorcon
McKinsey
Merck
Medtronic

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.