Jardiance is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 18 US drug patents filed from 2014 to 2023 out of which none have expired yet. Jardiance's patents will be open to challenges from 20 December, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 11, 2034. Details of Jardiance's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7579449 | Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture |
Aug, 2028
(3 years from now) | Active |
| US7713938 | Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments |
Apr, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9949998 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Dec, 2034
(9 years from now) | Active |
|
US9949997 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Nov, 2034
(9 years from now) | Active |
|
US11090323 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Oct, 2034
(9 years from now) | Active |
|
US10258637 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Oct, 2034
(9 years from now) | Active |
| US9949998 | Pharmaceutical composition, methods for treating and uses thereof |
Jun, 2034
(9 years from now) | Active |
| US9949997 | Pharmaceutical composition, methods for treating and uses thereof |
May, 2034
(9 years from now) | Active |
| US11833166 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US11813275 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US11666590 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US11090323 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US10258637 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US10406172 | Pharmaceutical composition, methods for treating and uses thereof |
Jun, 2030
(5 years from now) | Active |
|
US8551957 (Pediatric) | Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate |
Apr, 2030
(5 years from now) | Active |
| US8551957 | Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate |
Oct, 2029
(4 years from now) | Active |
|
US7579449 (Pediatric) | Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture |
Feb, 2029
(4 years from now) | Active |
|
US7713938 (Pediatric) | Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments |
Oct, 2027
(2 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Jardiance's patents.
Latest Legal Activities on Jardiance's Patents
Given below is the list of recent legal activities going on the following patents of Jardiance.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 05 Dec, 2023 | US11833166 |
| Email Notification Critical | 05 Dec, 2023 | US11833166 |
| Patent eGrant Notification | 05 Dec, 2023 | US11833166 |
| Recordation of Patent eGrant | 05 Dec, 2023 | US11833166 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Dec, 2023 | US11833166 |
| Mail Patent eGrant Notification | 05 Dec, 2023 | US11833166 |
| Email Notification Critical | 16 Nov, 2023 | US11833166 |
| Issue Notification Mailed Critical | 15 Nov, 2023 | US11833166 |
| Recordation of Patent Grant Mailed Critical | 14 Nov, 2023 | US11813275 |
| Email Notification Critical | 14 Nov, 2023 | US11813275 |
FDA has granted several exclusivities to Jardiance. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jardiance, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Jardiance.
Exclusivity Information
Jardiance holds 11 exclusivities out of which 7 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Jardiance's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-159) | Jun 26, 2018 |
| M(M-160) | Jun 26, 2018 |
| M(M-161) | Jun 26, 2018 |
| M(M-174) | Mar 18, 2019 |
| New Chemical Entity Exclusivity(NCE) | Aug 01, 2019 |
| New Indication(I-739) | Dec 02, 2019 |
| New Indication(I-869) | Aug 18, 2024 |
| M(M-82) | Feb 24, 2025 |
| Pediatric Exclusivity(PED) | Dec 20, 2026 |
| New Patient Population(NPP) | Jun 20, 2026 |
| New Indication(I-922) | Sep 21, 2026 |
Several oppositions have been filed on Jardiance's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Jardiance's generic, the next section provides detailed information on ongoing and past EP oppositions related to Jardiance patents.
Jardiance's Oppositions Filed in EPO
Jardiance has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jul 11, 2017, by Generics (U.K.) Limited. This opposition was filed on patent number EP08787264A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14715274A | Apr, 2023 | TEVA PHARMACEUTICAL INDUSTRIES, LTD. | Granted and Under Opposition |
| EP10703288A | Jan, 2021 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP10703288A | Jan, 2021 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP10703288A | Dec, 2020 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Stada-Arzneimittel Aktiengesellschaft | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Gillard, Richard Edward | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | EGIS Gyógyszergyár Zártkörüen Müködö Részvénytársaság | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | KRKA, d.d., Novo mesto | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | Hexal AG | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | Generics (U.K.) Limited | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Jardiance is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Jardiance's family patents as well as insights into ongoing legal events on those patents.
Jardiance's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Jardiance:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Jardiance(Empagliflozin) has 1 clinical trial that has been verified in 2024.
Generic Launch
Generic Release Date:
Jardiance's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 11, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jardiance Generic API suppliers:
Empagliflozin is the generic name for the brand Jardiance. 1 company has already filed for the generic of Jardiance. Check out the entire list of companies who have already received approval for Jardiance's generic
How can I launch a generic of Jardiance before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Jardiance's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Jardiance's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Jardiance -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg and 25 mg | 01 Aug, 2018 | 14 | 03 Aug, 2022 | 11 Jun, 2034 | Eligible |
Alternative Brands for Jardiance
Jardiance which is used for reducing cardiovascular risk and treating type 2 diabetes, heart failure, and chronic kidney disease with empagliflozin., has several other brand drugs in the same treatment category and using the same active ingredient (Empagliflozin). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim |
| |||||||||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Empagliflozin, Jardiance's active ingredient. Check the complete list of approved generic manufacturers for Jardiance
About Jardiance
Jardiance is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for reducing cardiovascular risk and treating type 2 diabetes, heart failure, and chronic kidney disease with empagliflozin. Jardiance uses Empagliflozin as an active ingredient. Jardiance was launched by Boehringer Ingelheim in 2014.
Approval Date:
Jardiance was approved by FDA for market use on 01 August, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Jardiance is 01 August, 2014, its NCE-1 date is estimated to be 20 December, 2025.
Active Ingredient:
Jardiance uses Empagliflozin as the active ingredient. Check out other Drugs and Companies using Empagliflozin ingredient
Treatment:
Jardiance is used for reducing cardiovascular risk and treating type 2 diabetes, heart failure, and chronic kidney disease with empagliflozin.
Dosage:
Jardiance is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |