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Last Updated: September 27, 2023

TRADJENTA Drug Patent Profile


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When do Tradjenta patents expire, and what generic alternatives are available?

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

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

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this compound. Two 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

See drug prices for TRADJENTA

Drug Sales Revenue Trends for TRADJENTA

See drug sales revenues for TRADJENTA

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 fourteen US patents and three FDA Regulatory Exclusivities.

Patents protecting TRADJENTA

Treatment for diabetes in patients inappropriate for metformin therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

DPP IV inhibitor formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH SULFONYLUREA

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH PIOGLITAZONE

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)

Uses of DPP-IV inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treatment for diabetes in patients inappropriate for metformin therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Treatment for diabetes in patients inappropriate for metformin therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting TRADJENTA

ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
Exclusivity Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Patent: 9930
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 07247193
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 0228
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0711179
Estimated Expiration: ⤷  Try a Trial

Patent: 0722388
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 49922
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 12002521
Estimated Expiration: ⤷  Try a Trial

Patent: 12002522
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1437493
Estimated Expiration: ⤷  Try a Trial

Patent: 2526737
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0100507
Estimated Expiration: ⤷  Try a Trial

Patent: 0150003
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 11354
Estimated Expiration: ⤷  Try a Trial

Patent: 16064
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 23902
Estimated Expiration: ⤷  Try a Trial

Patent: 77509
Estimated Expiration: ⤷  Try a Trial

Patent: 83819
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 088800
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 6559
Estimated Expiration: ⤷  Try a Trial

Patent: 9890
Estimated Expiration: ⤷  Try a Trial

Patent: 0802184
Estimated Expiration: ⤷  Try a Trial

Patent: 1100958
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 52108
Estimated Expiration: ⤷  Try a Trial

Patent: 23902
Estimated Expiration: ⤷  Try a Trial

Patent: 77509
Estimated Expiration: ⤷  Try a Trial

Patent: 83819
Estimated Expiration: ⤷  Try a Trial

Patent: 10241
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2007009091
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 30442
Estimated Expiration: ⤷  Try a Trial

Patent: 72549
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 25210
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 5030
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 78244
Estimated Expiration: ⤷  Try a Trial

Patent: 00998
Estimated Expiration: ⤷  Try a Trial

Patent: 64720
Estimated Expiration: ⤷  Try a Trial

Patent: 87908
Estimated Expiration: ⤷  Try a Trial

Patent: 84711
Estimated Expiration: ⤷  Try a Trial

Patent: 09535376
Estimated Expiration: ⤷  Try a Trial

Patent: 12072187
Estimated Expiration: ⤷  Try a Trial

Patent: 13227338
Estimated Expiration: ⤷  Try a Trial

Patent: 16104811
Estimated Expiration: ⤷  Try a Trial

Patent: 18021082
Estimated Expiration: ⤷  Try a Trial

Patent: 20079316
Estimated Expiration: ⤷  Try a Trial

Patent: 22075826
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 6969
Estimated Expiration: ⤷  Try a Trial

Patent: 8496
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 8617
Estimated Expiration: ⤷  Try a Trial

Patent: 08013958
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 170
Estimated Expiration: ⤷  Try a Trial

Patent: 941
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 2862
Estimated Expiration: ⤷  Try a Trial

Patent: 5983
Estimated Expiration: ⤷  Try a Trial

Patent: 3426
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 3067
Estimated Expiration: ⤷  Try a Trial

Patent: 084256
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 080698
Estimated Expiration: ⤷  Try a Trial

Patent: 110666
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 23902
Estimated Expiration: ⤷  Try a Trial

Patent: 77509
Estimated Expiration: ⤷  Try a Trial

Patent: 83819
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 23902
Estimated Expiration: ⤷  Try a Trial

Patent: 83819
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 466
Estimated Expiration: ⤷  Try a Trial

Patent: 570
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 1649
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 23902
Estimated Expiration: ⤷  Try a Trial

Patent: 83819
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0808361
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1478983
Estimated Expiration: ⤷  Try a Trial

Patent: 1710881
Estimated Expiration: ⤷  Try a Trial

Patent: 1855323
Estimated Expiration: ⤷  Try a Trial

Patent: 2051281
Estimated Expiration: ⤷  Try a Trial

Patent: 090009226
Estimated Expiration: ⤷  Try a Trial

Patent: 140063896
Estimated Expiration: ⤷  Try a Trial

Patent: 150100957
Estimated Expiration: ⤷  Try a Trial

Patent: 160128446
Estimated Expiration: ⤷  Try a Trial

Patent: 170141812
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 48576
Estimated Expiration: ⤷  Try a Trial

Patent: 27409
Estimated Expiration: ⤷  Try a Trial

Patent: 38818
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 74843
Estimated Expiration: ⤷  Try a Trial

Patent: 20753
Estimated Expiration: ⤷  Try a Trial

Patent: 0812648
Estimated Expiration: ⤷  Try a Trial

Patent: 1417844
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 942
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 319
Estimated Expiration: ⤷  Try a Trial

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
China 1216468 ⤷  Try a Trial
Spain 2158562 ⤷  Try a Trial
Eurasian Patent Organization 201101037 ЛЕЧЕНИЕ ДИАБЕТА У ПАЦИЕНТОВ С НЕАДЕКВАТНЫМ ГЛИКЕМИЧЕСКИМ КОНТРОЛЕМ, НЕСМОТРЯ НА ЛЕЧЕНИЕ МЕТФОРМИНОМ ⤷  Try a Trial
China 102526737 DPP IV inhibitor formulations ⤷  Try a Trial
European Patent Office 3539956 PROCEDE DE FABRICATION DE CHIRALE 8-(3-AMINO-PIPERIDINE-1-YL)-XANTHINE (METHOD FOR PRODUCING CHIRAL 8- (3-AMINO-PIPERIDIN-1-YL) -XANTHINES) ⤷  Try a Trial
Germany 50312295 ⤷  Try a Trial
Japan 2017105849 DPP IVインヒビターの使用 (USES OF DPP IV INHIBITORS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRADJENTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2187879 1790019-2 Sweden ⤷  Try a Trial PRODUCT NAME: COMBINATION OF EMPAGLIFLOZIN AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1146 20161115
0896538 08C0008 France ⤷  Try a Trial 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
1084705 C300706 Netherlands ⤷  Try a Trial PRODUCT NAME: VILDAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/414/001-017 20070926
2187879 132017000050485 Italy ⤷  Try a Trial PRODUCT NAME: COMBINAZIONE DI EMPAGLIFLOZIN E LINAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(GLYXAMBI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1146, 20161115
1532149 1190035-4 Sweden ⤷  Try a Trial PERIOD OF VALIDITY (FROM - UNTIL): 20230819 - 20260829
2187879 276 10-2017 Slovakia ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN/LINAGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1146 20161115
1084705 SPC/GB14/082 United Kingdom ⤷  Try a Trial PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323
>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.