Linagliptin Patent Expiration
Linagliptin is Used for treating type 2 diabetes, especially in patients with renal impairment and insufficient glycemic control. It was first introduced by Boehringer Ingelheim Pharmaceuticals Inc
Linagliptin Patents
Given below is the list of patents protecting Linagliptin, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Tradjenta |
US8853156 (Pediatric) | Treatment for diabetes in patients inappropriate for metformin therapy | Sep 05, 2031 | Boehringer Ingelheim |
| Tradjenta | US8853156 | Treatment for diabetes in patients inappropriate for metformin therapy | Mar 05, 2031 | Boehringer Ingelheim |
| Tradjenta |
US8846695 (Pediatric) | Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor | Dec 04, 2030 | Boehringer Ingelheim |
| Tradjenta | US8846695 | Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor | Jun 04, 2030 | Boehringer Ingelheim |
| Tradjenta | US11911388 | Treatment for diabetes in patients with insufficient glycemic control despite therapy with an oral or non-oral antidiabetic drug | Apr 10, 2030 | Boehringer Ingelheim |
| Tradjenta |
US10034877 (Pediatric) | Treatment for diabetes in patients inappropriate for metformin therapy | Feb 05, 2030 | Boehringer Ingelheim |
| Tradjenta |
US9486526 (Pediatric) | Treatment for diabetes in patients inappropriate for metformin therapy | Feb 05, 2030 | Boehringer Ingelheim |
| Tradjenta | US10034877 | Treatment for diabetes in patients inappropriate for metformin therapy | Aug 05, 2029 | Boehringer Ingelheim |
| Tradjenta | US9486526 | Treatment for diabetes in patients inappropriate for metformin therapy | Aug 05, 2029 | Boehringer Ingelheim |
| Tradjenta |
US11033552 (Pediatric) | DPP IV inhibitor formulations | Nov 04, 2027 | Boehringer Ingelheim |
| Tradjenta |
US8673927 (Pediatric) | Uses of DPP-IV inhibitors | Nov 04, 2027 | Boehringer Ingelheim |
| Tradjenta | US11033552 | DPP IV inhibitor formulations | May 04, 2027 | Boehringer Ingelheim |
| Tradjenta | US8673927 | Uses of DPP-IV inhibitors | May 04, 2027 | Boehringer Ingelheim |
| Tradjenta | US9173859 | Uses of DPP IV inhibitors | May 04, 2027 | Boehringer Ingelheim |
| Tradjenta |
US8883805 (Pediatric) | Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines | May 26, 2026 | Boehringer Ingelheim |
| Tradjenta | US8883805 | Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines | Nov 26, 2025 | Boehringer Ingelheim |
| Tradjenta |
US7407955 (Pediatric) | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions | Nov 02, 2025 | Boehringer Ingelheim |
| Tradjenta | US7407955 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions | May 02, 2025 | Boehringer Ingelheim |
| Tradjenta | US8119648 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Aug 12, 2023
(Expired) | Boehringer Ingelheim |
| Tradjenta | US8178541 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Aug 12, 2023
(Expired) | Boehringer Ingelheim |
| Tradjenta | US6890898 | Method of regulating glucose metabolism, and reagents related thereto |
Feb 02, 2019
(Expired) | Boehringer Ingelheim |
| Tradjenta | US7078381 | Method of regulating glucose metabolism, and reagents related thereto |
Feb 02, 2019
(Expired) | Boehringer Ingelheim |
| Tradjenta | US7459428 | Method of regulating glucose metabolism, and reagents related thereto |
Feb 02, 2019
(Expired) | Boehringer Ingelheim |
| Tradjenta | US6303661 | Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals |
Apr 24, 2017
(Expired) | Boehringer Ingelheim |
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 Linagliptin's patents.
Latest Legal Activities on Linagliptin's Patents
Given below is the list recent legal activities going on the following patents of Linagliptin.
| 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 |
Linagliptin's Family Patents
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Linagliptin Generic API Manufacturers
Several generic applications have been filed for Linagliptin. The first generic version for Linagliptin was by Sunshine Lake Pharma Co Ltd and was approved on Aug 31, 2021. And the latest generic version is by Invagen Pharmaceuticals Inc and was approved on Sep 3, 2024.
Given below is the list of companies who have filed for Linagliptin generic, along with the locations of their manufacturing plants worldwide.
1. INVAGEN PHARMS
Invagen Pharmaceuticals Inc has filed for 1 generic for Linagliptin. Given below are the details of the strengths of this generic introduced by Invagen Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Sep 3, 2024 |
2. SUNSHINE
Sunshine Lake Pharma Co Ltd has filed for 1 generic for Linagliptin. Given below are the details of the strengths of this generic introduced by Sunshine.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Aug 31, 2021 |
Manufacturing Plant Locations New
Sunshine's manufacturing plants are situated in 6 countries - United States, Peru, India, Thailand, China, Mozambique. Given below are the details of these plant locations as well as the firm names of Sunshine as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||||||||||||||
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| United States |
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| Peru |
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| India |
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| Thailand |
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| China |
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| Mozambique |
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3. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Linagliptin. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 5MG | tablet | Discontinued | ORAL | N/A | Mar 30, 2023 |