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Last Updated: September 25, 2022

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 thirteen 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 two FDA Regulatory Exclusivities.

Patents protecting TRADJENTA

Treatment for diabetes in patients inappropriate for metformin therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN WITHOUT DOSE ADJUSTMENT

DPP IV inhibitor formulations
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

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 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH SULFONLYUREA

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 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: 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 INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)

Uses of DPP-IV inhibitors
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 METFORMIN

Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
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 METFORMIN

Treatment for diabetes in patients inappropriate for metformin therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN

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

Treatment for diabetes in patients inappropriate for metformin therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL IMPAIRMENT AND WHO ARE INELIGIBLE FOR METFORMIN THERAPY BY ADMINISTERING LINAGLIPTIN

FDA Regulatory Exclusivity protecting TRADJENTA

ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
Exclusivity Expiration: See Plans and Pricing

INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
Exclusivity Expiration: 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
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 TRADJENTA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 9930
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07247193
Estimated Expiration: See Plans and Pricing

Austria

Patent: 0228
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0711179
Estimated Expiration: See Plans and Pricing

Patent: 0722388
Estimated Expiration: See Plans and Pricing

Canada

Patent: 49922
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12002521
Estimated Expiration: See Plans and Pricing

Patent: 12002522
Estimated Expiration: See Plans and Pricing

China

Patent: 1437493
Estimated Expiration: See Plans and Pricing

Patent: 2526737
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0100507
Estimated Expiration: See Plans and Pricing

Patent: 0150003
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 11354
Estimated Expiration: See Plans and Pricing

Patent: 16064
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 23902
Estimated Expiration: See Plans and Pricing

Patent: 77509
Estimated Expiration: See Plans and Pricing

Patent: 83819
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 088800
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 6559
Estimated Expiration: See Plans and Pricing

Patent: 9890
Estimated Expiration: See Plans and Pricing

Patent: 0802184
Estimated Expiration: See Plans and Pricing

Patent: 1100958
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 52108
Estimated Expiration: See Plans and Pricing

Patent: 23902
Estimated Expiration: See Plans and Pricing

Patent: 77509
Estimated Expiration: See Plans and Pricing

Patent: 83819
Estimated Expiration: See Plans and Pricing

Patent: 10241
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2007009091
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 30442
Estimated Expiration: See Plans and Pricing

Patent: 72549
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 25210
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5030
Estimated Expiration: See Plans and Pricing

Patent: 2841
Estimated Expiration: See Plans and Pricing

Japan

Patent: 78244
Estimated Expiration: See Plans and Pricing

Patent: 00998
Estimated Expiration: See Plans and Pricing

Patent: 64720
Estimated Expiration: See Plans and Pricing

Patent: 87908
Estimated Expiration: See Plans and Pricing

Patent: 84711
Estimated Expiration: See Plans and Pricing

Patent: 09535376
Estimated Expiration: See Plans and Pricing

Patent: 12072187
Estimated Expiration: See Plans and Pricing

Patent: 13227338
Estimated Expiration: See Plans and Pricing

Patent: 16104811
Estimated Expiration: See Plans and Pricing

Patent: 18021082
Estimated Expiration: See Plans and Pricing

Patent: 20079316
Estimated Expiration: See Plans and Pricing

Patent: 22075826
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 6969
Estimated Expiration: See Plans and Pricing

Patent: 8496
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 8617
Estimated Expiration: See Plans and Pricing

Patent: 08013958
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 170
Estimated Expiration: See Plans and Pricing

Patent: 941
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2862
Estimated Expiration: See Plans and Pricing

Patent: 5983
Estimated Expiration: See Plans and Pricing

Patent: 3426
Estimated Expiration: See Plans and Pricing

Norway

Patent: 3067
Estimated Expiration: See Plans and Pricing

Patent: 084256
Estimated Expiration: See Plans and Pricing

Peru

Patent: 080698
Estimated Expiration: See Plans and Pricing

Patent: 110666
Estimated Expiration: See Plans and Pricing

Poland

Patent: 23902
Estimated Expiration: See Plans and Pricing

Patent: 77509
Estimated Expiration: See Plans and Pricing

Patent: 83819
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 23902
Estimated Expiration: See Plans and Pricing

Patent: 83819
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 466
Estimated Expiration: See Plans and Pricing

Patent: 570
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 1649
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 23902
Estimated Expiration: See Plans and Pricing

Patent: 83819
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0808361
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1478983
Estimated Expiration: See Plans and Pricing

Patent: 1710881
Estimated Expiration: See Plans and Pricing

Patent: 1855323
Estimated Expiration: See Plans and Pricing

Patent: 2051281
Estimated Expiration: See Plans and Pricing

Patent: 090009226
Estimated Expiration: See Plans and Pricing

Patent: 140063896
Estimated Expiration: See Plans and Pricing

Patent: 150100957
Estimated Expiration: See Plans and Pricing

Patent: 160128446
Estimated Expiration: See Plans and Pricing

Patent: 170141812
Estimated Expiration: See Plans and Pricing

Spain

Patent: 48576
Estimated Expiration: See Plans and Pricing

Patent: 27409
Estimated Expiration: See Plans and Pricing

Patent: 38818
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 74843
Estimated Expiration: See Plans and Pricing

Patent: 20753
Estimated Expiration: See Plans and Pricing

Patent: 0812648
Estimated Expiration: See Plans and Pricing

Patent: 1417844
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 942
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 319
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 TRADJENTA around the world.

Country Patent Number Title Estimated Expiration
Mexico PA05001684 8-[3-AMINO-PIPERIDIN-1-IL]-XANTINAS, LA PREPARACION DEL MISMO Y SU USO COMO COMPOSICIONES FARMACEUTICAS. (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS.) See Plans and Pricing
Eurasian Patent Organization 200900536 СПОСОБ ПОЛУЧЕНИЯ ХИРАЛЬНЫХ 8-(3-АМИНОПИПЕРИДИН-1-ИЛ) КСАНТИНОВ See Plans and Pricing
Montenegro 01941 Formulacije DPP IV inhibitora (DPP IV inhibitor formulations) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRADJENTA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 2011C/038 Belgium 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-DIONE SES ENANTIOMERES OU L'UN DES SES SELS, EN PARTICULIER LA LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/11/707/001 20110830
2187879 132017000050485 Italy See Plans and Pricing 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
1084705 C300705 Netherlands See Plans and Pricing PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Colorcon
Merck
Dow
Harvard Business School

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.