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Last Updated: June 21, 2024

TRADJENTA Drug Patent Profile


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

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

This drug has four hundred and fifty-nine patent family members in forty-five countries.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the linagliptin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tradjenta

A generic version of TRADJENTA was approved as linagliptin by SUNSHINE on August 31st, 2021.

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Drug patent expirations by year for TRADJENTA
Drug Prices for TRADJENTA

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Drug Sales Revenue Trends for TRADJENTA

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Recent Clinical Trials for TRADJENTA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
EMSPhase 3
University of MiamiPhase 4
Northwell HealthPhase 4

See all TRADJENTA clinical trials

Pharmacology for TRADJENTA
Paragraph IV (Patent) Challenges for TRADJENTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRADJENTA Tablets linagliptin 5 mg 201280 11 2015-05-04

US Patents and Regulatory Information for TRADJENTA

TRADJENTA is protected by nine US patents and two FDA Regulatory Exclusivities.

Patents protecting TRADJENTA

Treatment for diabetes in patients inappropriate for metformin therapy
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DPP IV inhibitor formulations
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Patent Number: ⤷  Sign Up
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Patented Use: LINAGLIPTIN (5 MG DAILY DOSE) AND METFORMIN (WITH OR WITHOUT INSULIN) FOR TREATING TYPE 2 DIABETES PATIENTS WITH RENAL IMPAIRMENT AND INSUFFICIENT GLYCEMIC CONTROL DESPITE PREVIOUS TREATMENT WITH METFORMIN ALONE OR IN COMBINATION WITH INSULIN

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
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Uses of DPP-IV inhibitors
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Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
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Treatment for diabetes in patients inappropriate for metformin therapy
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Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
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Treatment for diabetes in patients inappropriate for metformin therapy
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FDA Regulatory Exclusivity protecting TRADJENTA

REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB 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 TRADJENTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TRADJENTA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Trajenta linagliptin EMEA/H/C/002110
Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Authorised no no no 2011-08-23
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TRADJENTA

When does loss-of-exclusivity occur for TRADJENTA?

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

Argentina

Patent: 0755
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Patent: 9930
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Australia

Patent: 07247193
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Austria

Patent: 80228
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Brazil

Patent: 0711179
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Patent: 0722388
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Canada

Patent: 49922
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Chile

Patent: 12002521
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Patent: 12002522
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China

Patent: 1437493
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Patent: 2526737
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Croatia

Patent: 0100507
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Patent: 0150003
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Cyprus

Patent: 11354
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Patent: 16064
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Denmark

Patent: 23902
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Patent: 77509
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Patent: 83819
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Ecuador

Patent: 088800
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Eurasian Patent Organization

Patent: 6559
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Patent: 9890
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Patent: 0802184
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Patent: 1100958
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European Patent Office

Patent: 52108
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Patent: 23902
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Patent: 77509
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Patent: 83819
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Patent: 10241
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Germany

Patent: 2007009091
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Hong Kong

Patent: 30442
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Patent: 72549
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Hungary

Patent: 25210
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Israel

Patent: 5030
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Japan

Patent: 78244
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Patent: 00998
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Patent: 64720
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Patent: 87908
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Patent: 84711
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Patent: 09535376
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Patent: 12072187
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Patent: 13227338
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Patent: 16104811
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Patent: 18021082
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Patent: 20079316
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Patent: 22075826
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Malaysia

Patent: 6969
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Patent: 8496
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Mexico

Patent: 8617
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Patent: 08013958
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Montenegro

Patent: 170
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Patent: 941
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New Zealand

Patent: 2862
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Patent: 5983
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Patent: 3426
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Norway

Patent: 3067
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Patent: 084256
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Peru

Patent: 080698
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Patent: 110666
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Poland

Patent: 23902
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Patent: 77509
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Patent: 83819
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Portugal

Patent: 23902
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Patent: 83819
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Serbia

Patent: 466
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Patent: 570
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Singapore

Patent: 1649
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Slovenia

Patent: 23902
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Patent: 83819
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South Africa

Patent: 0808361
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South Korea

Patent: 1478983
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Patent: 1710881
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Patent: 1855323
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Patent: 2051281
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Patent: 090009226
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Patent: 140063896
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Patent: 150100957
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Patent: 160128446
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Patent: 170141812
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Spain

Patent: 48576
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Patent: 27409
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Patent: 38818
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Taiwan

Patent: 74843
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Patent: 20753
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Patent: 0812648
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Patent: 1417844
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Ukraine

Patent: 942
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Uruguay

Patent: 319
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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 TRADJENTA around the world.

Country Patent Number Title Estimated Expiration
Canada 2755452 PROCEDE DE REGULATION DU METABOLISME DU GLUCOSE ET REACTIFS AFFERENTS (METHOD OF REGULATING GLUCOSE METABOLISM, AND REAGENTS RELATED THERETO) ⤷  Sign Up
Japan 2010159305 USE OF DPP-IV INHIBITOR ⤷  Sign Up
Cyprus 1115036 ⤷  Sign Up
Spain 2158562 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRADJENTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0896538 08C0008 France ⤷  Sign Up PRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926
1532149 PA2012022 Lithuania ⤷  Sign Up PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1084705 C01084705/01 Switzerland ⤷  Sign Up PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
0896538 300280 Netherlands ⤷  Sign Up 300280, 20170424, EXPIRES: 20220320
>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.