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 in its drug Tradjenta on May 2, 2011. 3 different companies have introduced drugs containing Linagliptin.


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 US10034877 Treatment for diabetes in patients inappropriate for metformin therapy Aug 05, 2029 Boehringer Ingelheim
Tradjenta US10034877

(Pediatric)

Treatment for diabetes in patients inappropriate for metformin therapy Feb 05, 2030 Boehringer Ingelheim
Tradjenta US11033552 DPP IV inhibitor formulations May 04, 2027 Boehringer Ingelheim
Tradjenta US11033552

(Pediatric)

DPP IV inhibitor formulations Nov 04, 2027 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 US6303661 Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals Apr 24, 2017

(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 US7407955 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions May 02, 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 US7459428 Method of regulating glucose metabolism, and reagents related thereto Feb 02, 2019

(Expired)

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 US8673927 Uses of DPP-IV inhibitors May 04, 2027 Boehringer Ingelheim
Tradjenta US8673927

(Pediatric)

Uses of DPP-IV inhibitors Nov 04, 2027 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 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 US8853156 Treatment for diabetes in patients inappropriate for metformin therapy Mar 05, 2031 Boehringer Ingelheim
Tradjenta US8853156

(Pediatric)

Treatment for diabetes in patients inappropriate for metformin therapy Sep 05, 2031 Boehringer Ingelheim
Tradjenta US8883805 Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Nov 26, 2025 Boehringer Ingelheim
Tradjenta US8883805

(Pediatric)

Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines May 26, 2026 Boehringer Ingelheim
Tradjenta US9173859 Uses of DPP IV inhibitors May 04, 2027 Boehringer Ingelheim
Tradjenta US9486526 Treatment for diabetes in patients inappropriate for metformin therapy Aug 05, 2029 Boehringer Ingelheim
Tradjenta US9486526

(Pediatric)

Treatment for diabetes in patients inappropriate for metformin therapy Feb 05, 2030 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.

Given below is the list recent legal activities going on the following patents of Linagliptin.

Event Date Patent/Publication
Patent litigations
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 31 Jul, 2018 US10034877
Patent Issue Date Used in PTA Calculation 31 Jul, 2018 US10034877
Email Notification 13 Jul, 2018 US10034877
Issue Notification Mailed 11 Jul, 2018 US10034877
Dispatch to FDC 02 Jul, 2018 US10034877
Mail Miscellaneous Communication to Applicant 12 Jun, 2018 US10034877



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Linagliptin Generics

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 Zydus Pharmaceuticals Usa Inc and was approved on Mar 30, 2023.

Given below is the list of companies who have filed for Linagliptin generic.


1. 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


2. 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