Tradjenta is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 24 US drug patents filed from 2013 to 2024. Out of these, 18 drug patents are active and 6 have expired. Tradjenta's patents will be open to challenges from 20 December, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 05, 2031. Details of Tradjenta's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7407955 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
May, 2025
(5 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US8853156 (Pediatric) | Treatment for diabetes in patients inappropriate for metformin therapy |
Sep, 2031
(6 years from now) | Active |
| US8853156 | Treatment for diabetes in patients inappropriate for metformin therapy |
Mar, 2031
(6 years from now) | Active |
|
US8846695 (Pediatric) | Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor |
Dec, 2030
(6 years from now) | Active |
| US8846695 | Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor |
Jun, 2030
(5 years from now) | Active |
| US11911388 | Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral or non-oral antidiabetic drug |
Apr, 2030
(5 years from now) | Active |
|
US10034877 (Pediatric) | Treatment for diabetes in patients inappropriate for metformin therapy |
Feb, 2030
(5 years from now) | Active |
|
US9486526 (Pediatric) | Treatment for diabetes in patients inappropriate for metformin therapy |
Feb, 2030
(5 years from now) | Active |
| US10034877 | Treatment for diabetes in patients inappropriate for metformin therapy |
Aug, 2029
(4 years from now) | Active |
| US9486526 | Treatment for diabetes in patients inappropriate for metformin therapy |
Aug, 2029
(4 years from now) | Active |
|
US11033552 (Pediatric) | DPP IV inhibitor formulations |
Nov, 2027
(2 years from now) | Active |
|
US8673927 (Pediatric) | Uses of DPP-IV inhibitors |
Nov, 2027
(2 years from now) | Active |
| US8673927 | Uses of DPP-IV inhibitors |
May, 2027
(2 years from now) | Active |
| US9173859 | Uses of DPP IV inhibitors |
May, 2027
(2 years from now) | Active |
| US11033552 | DPP IV inhibitor formulations |
May, 2027
(2 years from now) | Active |
|
US8883805 (Pediatric) | Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines |
May, 2026
(1 year, 6 months from now) | Active |
| US8883805 | Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines |
Nov, 2025
(1 year, 10 days from now) | Active |
|
US7407955 (Pediatric) | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Nov, 2025
(11 months from now) | Active |
| US8119648 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Aug, 2023
(1 year, 3 months ago) |
Expired
|
| US8178541 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Aug, 2023
(1 year, 3 months ago) |
Expired
|
| US6890898 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(5 years ago) |
Expired
|
| US7078381 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(5 years ago) |
Expired
|
| US7459428 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(5 years ago) |
Expired
|
| US6303661 | Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals |
Apr, 2017
(7 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tradjenta's patents.
Latest Legal Activities on Tradjenta's Patents
Given below is the list of recent legal activities going on the following patents of Tradjenta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 May, 2024 | US9486526 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Mar, 2022 | US8853156 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Jan, 2022 | US10034877 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Apr, 2020 | US9486526 |
| Recordation of Patent Grant Mailed Critical | 31 Jul, 2018 | US10034877 |
| Patent Issue Date Used in PTA Calculation Critical | 31 Jul, 2018 | US10034877 |
| Email Notification Critical | 13 Jul, 2018 | US10034877 |
| Issue Notification Mailed Critical | 11 Jul, 2018 | US10034877 |
| Dispatch to FDC | 02 Jul, 2018 | US10034877 |
| Mail Miscellaneous Communication to Applicant | 12 Jun, 2018 | US10034877 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Tradjenta and ongoing litigations to help you estimate the early arrival of Tradjenta generic.
Tradjenta's Litigations
Tradjenta been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 10, 2016, against patent number US9173859. The petitioner Mylan Pharmaceuticals Inc., challenged the validity of this patent, with Boehringer Ingelheim Pharmaceuticals Inc. as the respondent. Click below to track the latest information on how companies are challenging Tradjenta's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8853156 | August, 2016 |
Terminated
(01 Aug, 2017) | Boehringer Ingelheim Pharmaceuticals Inc. et al. | Mylan Pharmaceuticals Inc. et al. |
| US8673927 | August, 2016 |
Terminated
(18 Jul, 2017) | Boehringer Ingelheim Pharmaceuticals Inc. et al. | Mylan Pharmaceuticals Inc. et al. |
| US8846695 | August, 2016 |
Terminated
(18 Jul, 2017) | Boehringer Ingelheim Pharmaceuticals Inc. et al. | Mylan Pharmaceuticals Inc. et al. |
| US9173859 | August, 2016 |
Terminated-Denied
(03 Feb, 2017) | Boehringer Ingelheim Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. |
FDA has granted some exclusivities to Tradjenta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tradjenta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Tradjenta.
Exclusivity Information
Tradjenta holds 7 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Tradjenta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-118) | Aug 13, 2015 |
| M(M-121) | Aug 13, 2015 |
| New Chemical Entity Exclusivity(NCE) | May 02, 2016 |
| M(M-258) | Jul 03, 2022 |
| M(M-252) | Mar 30, 2023 |
| M(M-295) | Jun 20, 2026 |
| Pediatric Exclusivity(PED) | Dec 20, 2026 |
Several oppositions have been filed on Tradjenta's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tradjenta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tradjenta patents.
Tradjenta's Oppositions Filed in EPO
Tradjenta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 05, 2015, by Hexal Ag. This opposition was filed on patent number EP07728723A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP11179908A | Apr, 2023 | Generics [UK] Limited | Granted and Under Opposition |
| EP11179908A | Apr, 2023 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP11179908A | Apr, 2023 | Kraus & Weisert Patentanwälte PartGmbB | Granted and Under Opposition |
| EP11179908A | Apr, 2023 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP11179908A | Apr, 2023 | Sandoz AG | Granted and Under Opposition |
| EP10175188A | Dec, 2015 | Generics (UK) Limited | Revoked |
| EP10175188A | Dec, 2015 | Galenicum Health S.L. | Revoked |
| EP10175188A | Dec, 2015 | Hexal AG | Revoked |
| EP10175188A | Dec, 2015 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP10175188A | Dec, 2015 | STADA Arzneimittel AG | Revoked |
| EP10175638A | Jul, 2015 | Generics [UK] Limited (trading as Mylan) | Revoked |
| EP10175638A | Jul, 2015 | STADA Arzneimittel AG | Revoked |
| EP10175638A | Jul, 2015 | Teva Pharmaceutical Industries Ltd. | Revoked |
| EP10175638A | Jul, 2015 | Hexal AG | Revoked |
| EP07728723A | Jan, 2015 | Hexal AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Tradjenta is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Tradjenta's family patents as well as insights into ongoing legal events on those patents.
Tradjenta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tradjenta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 05, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tradjenta Generic API suppliers:
Linagliptin is the generic name for the brand Tradjenta. 3 different companies have already filed for the generic of Tradjenta, with Invagen Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tradjenta's generic
How can I launch a generic of Tradjenta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tradjenta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tradjenta's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Tradjenta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg | 04 May, 2015 | 11 | 31 Aug, 2021 | 04 Jun, 2030 | Deferred |
Alternative Brands for Tradjenta
Tradjenta which is used for treating type 2 diabetes, especially in patients with renal impairment and insufficient glycemic control., has several other brand drugs in the same treatment category and using the same active ingredient (Linagliptin). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca Ab |
| |||||||||
| Boehringer Ingelheim |
| |||||||||
| Cosette |
| |||||||||
| Janssen Pharms |
| |||||||||
| Merck Sharp Dohme |
| |||||||||
| Sb Pharmco |
| |||||||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Linagliptin. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Boehringer Ingelheim |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Linagliptin, Tradjenta's active ingredient. Check the complete list of approved generic manufacturers for Tradjenta
About Tradjenta
Tradjenta is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for treating type 2 diabetes, especially in patients with renal impairment and insufficient glycemic control. Tradjenta uses Linagliptin as an active ingredient. Tradjenta was launched by Boehringer Ingelheim in 2011.
Approval Date:
Tradjenta was approved by FDA for market use on 02 May, 2011.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Tradjenta is 02 May, 2011, its NCE-1 date is estimated to be 20 December, 2025.
Active Ingredient:
Tradjenta uses Linagliptin as the active ingredient. Check out other Drugs and Companies using Linagliptin ingredient
Treatment:
Tradjenta is used for treating type 2 diabetes, especially in patients with renal impairment and insufficient glycemic control.
Dosage:
Tradjenta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | TABLET | Prescription | ORAL |