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.
Summary for TRADJENTA
International Patents: | 415 |
US Patents: | 10 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 92 |
Clinical Trials: | 10 |
Patent Applications: | 1,898 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TRADJENTA |
Drug Sales Revenues: | Drug sales revenues for TRADJENTA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRADJENTA |
What excipients (inactive ingredients) are in TRADJENTA? | TRADJENTA excipients list |
DailyMed Link: | TRADJENTA at DailyMed |



Recent Clinical Trials for TRADJENTA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
EMS | Phase 3 |
University of Miami | Phase 4 |
Northwell Health | Phase 4 |
Pharmacology for TRADJENTA
Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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
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 |