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Last Updated: May 26, 2022

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-four patent family members in forty-seven 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 Generic Entry Opportunity 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 sixteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRIJARDY XR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A TREATMENT-NAIVE PATIENT WITH INADEQUATELY CONTROLLED TYPE 2 DIABETES USING A COMPOSITION COMPRISING AN EXTENDED RELEASE CORE COMPRISINGMETFORMIN AND AN OUTER COATING COMPRISING EMPAGLIFLOZIN AND LINAGLIPTIN

Pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (EGFR=45 ML/MIN/1.73 M2 AND DISCONTINUATION IF EGFR

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

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN

Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN

Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

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

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2

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 212614-003 Jan 27, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-002 Jan 27, 2020 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRIJARDY XR empagliflozin; linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 212614-004 Jan 27, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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: See Plans and Pricing

Australia

Patent: 09232043
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0911273
Estimated Expiration: See Plans and Pricing

Canada

Patent: 20450
Estimated Expiration: See Plans and Pricing

Chile

Patent: 09000809
Estimated Expiration: See Plans and Pricing

China

Patent: 1983073
Estimated Expiration: See Plans and Pricing

Patent: 3083672
Estimated Expiration: See Plans and Pricing

Patent: 6215190
Estimated Expiration: See Plans and Pricing

Patent: 3648422
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 51277
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 85410
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010489
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 9395
Estimated Expiration: See Plans and Pricing

Patent: 8435
Estimated Expiration: See Plans and Pricing

Patent: 1001577
Estimated Expiration: See Plans and Pricing

Patent: 1300121
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 85410
Estimated Expiration: See Plans and Pricing

Patent: 53403
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 49485
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 41649
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7497
Estimated Expiration: See Plans and Pricing

Patent: 5637
Estimated Expiration: See Plans and Pricing

Japan

Patent: 88428
Estimated Expiration: See Plans and Pricing

Patent: 22068
Estimated Expiration: See Plans and Pricing

Patent: 11516456
Estimated Expiration: See Plans and Pricing

Patent: 13237707
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 1232
Estimated Expiration: See Plans and Pricing

Patent: 10010819
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 200
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7747
Estimated Expiration: See Plans and Pricing

Patent: 9580
Estimated Expiration: See Plans and Pricing

Peru

Patent: 091730
Estimated Expiration: See Plans and Pricing

Patent: 140960
Estimated Expiration: See Plans and Pricing

Poland

Patent: 85410
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1005664
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1611314
Estimated Expiration: See Plans and Pricing

Patent: 1775942
Estimated Expiration: See Plans and Pricing

Patent: 110005690
Estimated Expiration: See Plans and Pricing

Patent: 160042174
Estimated Expiration: See Plans and Pricing

Patent: 170056021
Estimated Expiration: See Plans and Pricing

Spain

Patent: 96124
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 27816
Estimated Expiration: See Plans and Pricing

Patent: 0946534
Estimated Expiration: See Plans and Pricing

Patent: 1509941
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000431
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1818886
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4136
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 747
Estimated Expiration: See Plans and Pricing

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
Japan 6662970 See Plans and Pricing
Hong Kong 1149485 DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION See Plans and Pricing
South Korea 101174726 See Plans and Pricing
China 102964347 8-[3-amino-piperidin-1-yl]-xanthines, the production thereof and the use of the same as medicaments See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRIJARDY XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 8/2012 Austria See Plans and Pricing PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830
1730131 92555 Luxembourg See Plans and Pricing 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
1532149 CR 2011 00030 Denmark See Plans and Pricing PRODUCT NAME: LINAGLIPTIN OG SALTE DERAF; NAT. REG. NO/DATE: EU/1/11/707/001-011 20110830; FIRST REG. NO/DATE: EU EU/1/11/707/001-0011 20110830
1532149 C20110018 00046 Estonia See Plans and Pricing PRODUCT NAME: TRAJENTA-LINAGLIPTIN; REG NO/DATE: FINAL 24.08.2011
>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:

Johnson and Johnson
Boehringer Ingelheim
Dow
Medtronic
AstraZeneca
Mallinckrodt

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.