Trijardy Xr Patent Expiration

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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7407955 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
May, 2025

(9 months 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
US7579449 Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Aug, 2028

(4 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6488962 Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms
Jun, 2020

(4 years ago)

Expired
US8178541 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Aug, 2023

(11 months ago)

Expired
US8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Aug, 2023

(11 months ago)

Expired
US7407955

(Pediatric)

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Nov, 2025

(1 year, 3 months from now)

Active
US8883805 Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Nov, 2025

(1 year, 4 months from now)

Active
US8883805

(Pediatric)

Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
May, 2026

(1 year, 10 months 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
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

(3 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
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
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
US8551957 Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Oct, 2029

(5 years from now)

Active
US8551957

(Pediatric)

Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Apr, 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
US10406172 Pharmaceutical composition, methods for treating and uses thereof
Jun, 2030

(5 years from now)

Active
US10596120 Pharmaceutical compositions
Mar, 2032

(7 years from now)

Active
US11564886 Pharmaceutical compositions
Mar, 2032

(7 years from now)

Active
US10258637 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
US11833166 Pharmaceutical composition, methods for treating and uses thereof
Apr, 2034

(9 years from now)

Active
US9949998 Pharmaceutical composition, methods for treating and uses thereof
Jun, 2034

(9 years from now)

Active
US11090323

(Pediatric)

Pharmaceutical composition, methods for treating and uses thereof
Oct, 2034

(10 years from now)

Active
US10258637

(Pediatric)

Pharmaceutical composition, methods for treating and uses thereof
Oct, 2034

(10 years from now)

Active
US9949998

(Pediatric)

Pharmaceutical composition, methods for treating and uses thereof
Dec, 2034

(10 years from now)

Active


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 has 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 or infringement 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
Patent litigations
US8673927 August, 2016 Terminated-Adverse Judgment Boehringer Ingelheim Pharmaceuticals Inc. Mylan Pharmaceuticals Inc.
US9173859 August, 2016 Terminated-Denied Boehringer Ingelheim Pharmaceuticals Inc. Mylan Pharmaceuticals Inc.

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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
Patent litigations
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

Trijardy Xr has patent protection in a total of 50 countries. It's US patent count contributes only to 11.1% of its total global patent coverage. 2 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Trijardy Xr.

Family Patents

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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




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.

Market Authorisation 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
25MG;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
5MG;2.5MG;1GM TABLET, EXTENDED RELEASE Prescription ORAL