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Last Updated: June 20, 2024

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TRIJARDY XR Drug Patent Profile


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When do Trijardy Xr patents expire, and when can generic versions of Trijardy Xr launch?

Trijardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and eighty-five patent family members in forty-eight countries.

The generic ingredient in TRIJARDY XR is empagliflozin; linagliptin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin; metformin hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Trijardy Xr

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 21, 2030. This may change due to patent challenges or generic licensing.

There have been twenty-one 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.

Indicators of Generic Entry

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Drug patent expirations by year for TRIJARDY XR
Drug Prices for TRIJARDY XR

See drug prices for TRIJARDY XR

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TRIJARDY XR
Generic Entry Date for TRIJARDY XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;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.

Paragraph IV (Patent) Challenges for TRIJARDY XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRIJARDY XR Extended-release Tablets empagliflozin; linagliptin; metformin hydrochloride 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 212614 1 2020-05-26

US Patents and Regulatory Information for TRIJARDY XR

TRIJARDY XR is protected by seventeen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRIJARDY XR is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TRIJARDY XR

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN

Pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF A TYPE 2 DIABETES PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN THERAPY USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISING METFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-003 Jan 27, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TRIJARDY XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 Jan 27, 2020 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-001 Jan 27, 2020 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TRIJARDY XR

When does loss-of-exclusivity occur for TRIJARDY XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1175
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09232043
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0911273
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 20450
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 09000809
Estimated Expiration: ⤷  Sign Up

China

Patent: 1983073
Estimated Expiration: ⤷  Sign Up

Patent: 3083672
Estimated Expiration: ⤷  Sign Up

Patent: 6215190
Estimated Expiration: ⤷  Sign Up

Patent: 3648422
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 51277
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 85410
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 10010489
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 9395
Estimated Expiration: ⤷  Sign Up

Patent: 8435
Estimated Expiration: ⤷  Sign Up

Patent: 1001577
Estimated Expiration: ⤷  Sign Up

Patent: 1300121
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 85410
Estimated Expiration: ⤷  Sign Up

Patent: 53403
Estimated Expiration: ⤷  Sign Up

Patent: 44374
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 49485
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 41649
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 88428
Estimated Expiration: ⤷  Sign Up

Patent: 22068
Estimated Expiration: ⤷  Sign Up

Patent: 11516456
Estimated Expiration: ⤷  Sign Up

Patent: 13237707
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 1232
Estimated Expiration: ⤷  Sign Up

Patent: 10010819
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 200
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 7747
Estimated Expiration: ⤷  Sign Up

Patent: 9580
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 091730
Estimated Expiration: ⤷  Sign Up

Patent: 140960
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 85410
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1005664
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1611314
Estimated Expiration: ⤷  Sign Up

Patent: 1775942
Estimated Expiration: ⤷  Sign Up

Patent: 110005690
Estimated Expiration: ⤷  Sign Up

Patent: 160042174
Estimated Expiration: ⤷  Sign Up

Patent: 170056021
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 96124
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 27816
Estimated Expiration: ⤷  Sign Up

Patent: 0946534
Estimated Expiration: ⤷  Sign Up

Patent: 1509941
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 10000431
Estimated Expiration: ⤷  Sign Up

Turkey

Patent: 1818886
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4136
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 747
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRIJARDY XR around the world.

Country Patent Number Title Estimated Expiration
Serbia 51216 KRISTALNI OBLIK-HLORO-4-(ß-D-GLUKOPIRANOZ-1-IL) -2 - [4-((S)-TETRAHIDROFURAN-3-ILOKSI)-BENZIL]-BENZOLA, POSTUPAK ZA NJEGOVO DOBIJANJE I NJEGOVA PRIMENA ZA DOBIJANJE LEKOVA (CRYSTALLINE FORM OF-CHLORO-4- ß-D-GLUKOPYRANOS-1-YL) -2 - [4-((S)-TETRAHYDROFURAN-3-YLOKSI)-BENZIL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS) ⤷  Sign Up
Denmark 2287164 ⤷  Sign Up
Taiwan I524894 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRIJARDY XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 CA 2011 00030 Denmark ⤷  Sign Up
2187879 LUC00017 Luxembourg ⤷  Sign Up PRODUCT NAME: GLYXAMBI- EMPAGLIFLOZINE/LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1146 20161115
1730131 C01730131/03 Switzerland ⤷  Sign Up 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

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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.