Trijardy Xr is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 28 US drug patents filed from 2020 to 2023. Out of these, 25 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 11, 2034. Details of Trijardy Xr'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 |
| US7407955 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
May, 2025
(6 months 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
(10 years from now) | Active |
|
US10258637 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Oct, 2034
(9 years from now) | Active |
|
US11090323 (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 |
| US11090323 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US11833166 | 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 |
| US11564886 | Pharmaceutical compositions |
Mar, 2032
(7 years from now) | Active |
| US10596120 | Pharmaceutical compositions |
Mar, 2032
(7 years from now) | Active |
| US10406172 | Pharmaceutical composition, methods for treating and uses thereof |
Jun, 2030
(5 years from now) | Active |
| US9155705 | DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation |
May, 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 |
| US10022379 | DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation |
Apr, 2029
(4 years from now) | Active |
| US9415016 | DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation |
Apr, 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 |
| US8673927 | Uses of DPP-IV inhibitors |
May, 2027
(2 years from now) | Active |
| US9173859 | Uses of DPP IV inhibitors |
May, 2027
(2 years from now) | Active |
|
US8883805 (Pediatric) | Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines |
May, 2026
(1 year, 6 months from now) | Active |
| US8883805 | Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines |
Nov, 2025
(1 year, 1 month from now) | Active |
|
US7407955 (Pediatric) | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Nov, 2025
(1 year, 8 days from now) | Active |
| US8119648 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Aug, 2023
(1 year, 2 months ago) |
Expired
|
| US8178541 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Aug, 2023
(1 year, 2 months ago) |
Expired
|
| US6488962 | Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms |
Jun, 2020
(4 years ago) |
Expired
|
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 Trijardy Xr's patents.
Latest Legal Activities on Trijardy Xr's Patents
Given below is the list of recent legal activities going on the following patents of Trijardy Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Sep, 2023 | US10596120 |
| Recordation of Patent Grant Mailed Critical | 31 Jan, 2023 | US11564886 |
| Patent Issue Date Used in PTA Calculation Critical | 31 Jan, 2023 | US11564886 |
| Email Notification Critical | 12 Jan, 2023 | US11564886 |
| Issue Notification Mailed Critical | 11 Jan, 2023 | US11564886 |
| Application Is Considered Ready for Issue Critical | 27 Dec, 2022 | US11564886 |
| Dispatch to FDC | 27 Dec, 2022 | US11564886 |
| Issue Fee Payment Received Critical | 21 Dec, 2022 | US11564886 |
| Issue Fee Payment Verified Critical | 21 Dec, 2022 | US11564886 |
| Mail Notice of Allowance Critical | 27 Sep, 2022 | US11564886 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Trijardy Xr and ongoing litigations to help you estimate the early arrival of Trijardy Xr generic.
Trijardy Xr's Litigations
Trijardy Xr been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 10, 2016, against patent number US9173859. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with Boehringer Ingelheim Pharmaceuticals Inc. as the respondent. Click below to track the latest information on how companies are challenging Trijardy Xr's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8673927 | August, 2016 |
Terminated
(18 Jul, 2017) | Boehringer Ingelheim Pharmaceuticals Inc. et al. | Mylan Pharmaceuticals Inc. et al. |
| US9173859 | August, 2016 |
Terminated-Denied
(03 Feb, 2017) | Boehringer Ingelheim Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. |
Several oppositions have been filed on Trijardy Xr'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 Trijardy Xr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Trijardy Xr patents.
Trijardy Xr's Oppositions Filed in EPO
Trijardy Xr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 05, 2015, by Hexal Ag. This opposition was filed on patent number EP07728723A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP11179908A | Apr, 2023 | Generics [UK] Limited | Granted and Under Opposition |
| EP11179908A | Apr, 2023 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP11179908A | Apr, 2023 | Kraus & Weisert Patentanwälte PartGmbB | Granted and Under Opposition |
| EP11179908A | Apr, 2023 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP11179908A | Apr, 2023 | Sandoz AG | 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 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Stada-Arzneimittel Aktiengesellschaft | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Gillard, Richard Edward | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | 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 |
| EP09728065A | Jun, 2019 | isarpatent - Patent- und Rechtsanwälte Behnisch Barth Charles Hassa Peckmann und Partner mbB | Revoked |
| EP09728065A | Jun, 2019 | Galenicum Health S.L.U. | Revoked |
| EP09728065A | Jun, 2019 | HGF Limited | Revoked |
| EP09728065A | Jun, 2019 | Hexal AG | Revoked |
| EP08787264A | Jul, 2017 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | Hexal AG | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP07728723A | Jan, 2015 | Hexal AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Trijardy Xr 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 Trijardy Xr's family patents as well as insights into ongoing legal events on those patents.
Trijardy Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Trijardy Xr's generic launch date based on the expiry of its last outstanding patent 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)
Trijardy Xr Generics:
There are no approved generic versions for Trijardy Xr as of now.
How can I launch a generic of Trijardy Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Trijardy Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Trijardy Xr'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 Trijardy Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/2.5 mg/1 g, 10 mg/5 mg/1 g, 12.5 mg/5 mg/1 g, 25 mg/5 mg/1 g | 26 May, 2020 | 1 | 03 Apr, 2034 |
Alternative Brands for Trijardy Xr
Trijardy Xr which is used for treating Type 2 diabetes mellitus with insufficient glycemic control despite metformin therapy., has several other brand drugs in the same treatment category . 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 |
| |||||||||
About Trijardy Xr
Trijardy Xr is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for treating Type 2 diabetes mellitus with insufficient glycemic control despite metformin therapy. Trijardy Xr uses Empagliflozin; Linagliptin; Metformin Hydrochloride as an active ingredient. Trijardy Xr was launched by Boehringer Ingelheim in 2020.
Approval Date:
Trijardy Xr was approved by FDA for market use on 27 January, 2020.
Active Ingredient:
Trijardy Xr uses Empagliflozin; Linagliptin; Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Empagliflozin; Linagliptin; Metformin Hydrochloride ingredient
Treatment:
Trijardy Xr is used for treating Type 2 diabetes mellitus with insufficient glycemic control despite metformin therapy.
Dosage:
Trijardy Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG;2.5MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 10MG;5MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 12.5MG;2.5MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 25MG;5MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |