Linagliptin; Metformin Hydrochloride Patent Expiration

Linagliptin; Metformin Hydrochloride is used for managing type 2 diabetes with renal impairment and inadequate glycemic control. It was first introduced by Boehringer Ingelheim Pharmaceuticals Inc in its drug Jentadueto on Jan 30, 2012. Another drug containing Linagliptin; Metformin Hydrochloride is Jentadueto Xr. 3 different companies have introduced drugs containing Linagliptin; Metformin Hydrochloride.


Linagliptin; Metformin Hydrochloride Patents

Given below is the list of patents protecting Linagliptin; Metformin Hydrochloride, 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
Jentadueto Xr US9555001

(Pediatric)

Pharmaceutical composition and uses thereof Sep 06, 2033 Boehringer Ingelheim
Jentadueto Xr US9555001 Pharmaceutical composition and uses thereof Mar 06, 2033 Boehringer Ingelheim
Jentadueto US8846695

(Pediatric)

Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor Dec 04, 2030 Boehringer Ingelheim
Jentadueto US9155705

(Pediatric)

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Nov 21, 2030 Boehringer Ingelheim
Jentadueto Xr US9155705

(Pediatric)

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Nov 21, 2030 Boehringer Ingelheim
Jentadueto US8846695 Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor Jun 04, 2030 Boehringer Ingelheim
Jentadueto Xr US8846695 Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor Jun 04, 2030 Boehringer Ingelheim
Jentadueto US9155705 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation May 21, 2030 Boehringer Ingelheim
Jentadueto Xr US9155705 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation May 21, 2030 Boehringer Ingelheim
Jentadueto 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
Jentadueto Xr 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
Jentadueto US10022379

(Pediatric)

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Oct 02, 2029 Boehringer Ingelheim
Jentadueto US10973827

(Pediatric)

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Oct 02, 2029 Boehringer Ingelheim
Jentadueto US9415016

(Pediatric)

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Oct 02, 2029 Boehringer Ingelheim
Jentadueto Xr US10022379

(Pediatric)

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Oct 02, 2029 Boehringer Ingelheim
Jentadueto Xr US9415016

(Pediatric)

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Oct 02, 2029 Boehringer Ingelheim
Jentadueto US10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Apr 02, 2029 Boehringer Ingelheim
Jentadueto US10973827 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Apr 02, 2029 Boehringer Ingelheim
Jentadueto US9415016 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Apr 02, 2029 Boehringer Ingelheim
Jentadueto Xr US10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Apr 02, 2029 Boehringer Ingelheim
Jentadueto Xr US9415016 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation Apr 02, 2029 Boehringer Ingelheim
Jentadueto US8673927

(Pediatric)

Uses of DPP-IV inhibitors Nov 04, 2027 Boehringer Ingelheim
Jentadueto Xr US8673927

(Pediatric)

Uses of DPP-IV inhibitors Nov 04, 2027 Boehringer Ingelheim
Jentadueto Xr US9173859

(Pediatric)

Uses of DPP IV inhibitors Nov 04, 2027 Boehringer Ingelheim
Jentadueto US8673927 Uses of DPP-IV inhibitors May 04, 2027 Boehringer Ingelheim
Jentadueto US9173859 Uses of DPP IV inhibitors May 04, 2027 Boehringer Ingelheim
Jentadueto Xr US8673927 Uses of DPP-IV inhibitors May 04, 2027 Boehringer Ingelheim
Jentadueto Xr US9173859 Uses of DPP IV inhibitors May 04, 2027 Boehringer Ingelheim
Jentadueto US8883805

(Pediatric)

Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines May 26, 2026 Boehringer Ingelheim
Jentadueto Xr US8883805

(Pediatric)

Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines May 26, 2026 Boehringer Ingelheim
Jentadueto US8883805 Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Nov 26, 2025 Boehringer Ingelheim
Jentadueto Xr US8883805 Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines Nov 26, 2025 Boehringer Ingelheim
Jentadueto US7407955

(Pediatric)

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Nov 02, 2025 Boehringer Ingelheim
Jentadueto Xr US7407955

(Pediatric)

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Nov 02, 2025 Boehringer Ingelheim
Jentadueto US7407955 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions May 02, 2025 Boehringer Ingelheim
Jentadueto Xr US7407955 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions May 02, 2025 Boehringer Ingelheim
Jentadueto US8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Aug 12, 2023

(Expired)

Boehringer Ingelheim
Jentadueto US8178541 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Aug 12, 2023

(Expired)

Boehringer Ingelheim
Jentadueto Xr US8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Aug 12, 2023

(Expired)

Boehringer Ingelheim
Jentadueto Xr US8178541 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions Aug 12, 2023

(Expired)

Boehringer Ingelheim
Jentadueto Xr US6488962 Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms Jun 20, 2020

(Expired)

Boehringer Ingelheim
Jentadueto US6890898 Method of regulating glucose metabolism, and reagents related thereto Feb 02, 2019

(Expired)

Boehringer Ingelheim
Jentadueto US7078381 Method of regulating glucose metabolism, and reagents related thereto Feb 02, 2019

(Expired)

Boehringer Ingelheim
Jentadueto US7459428 Method of regulating glucose metabolism, and reagents related thereto Feb 02, 2019

(Expired)

Boehringer Ingelheim
Jentadueto Xr US6890898 Method of regulating glucose metabolism, and reagents related thereto Feb 02, 2019

(Expired)

Boehringer Ingelheim
Jentadueto Xr US7078381 Method of regulating glucose metabolism, and reagents related thereto Feb 02, 2019

(Expired)

Boehringer Ingelheim
Jentadueto Xr US7459428 Method of regulating glucose metabolism, and reagents related thereto Feb 02, 2019

(Expired)

Boehringer Ingelheim
Jentadueto US6303661 Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals Apr 24, 2017

(Expired)

Boehringer Ingelheim
Jentadueto Xr US6303661 Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals Apr 24, 2017

(Expired)

Boehringer Ingelheim
Jentadueto Xr US6340475 Extending the duration of drug release within the stomach during the fed mode Sep 19, 2016

(Expired)

Boehringer Ingelheim
Jentadueto Xr US6635280 Extending the duration of drug release within the stomach during the fed mode Sep 19, 2016

(Expired)

Boehringer Ingelheim



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Linagliptin; Metformin Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Linagliptin; Metformin Hydrochloride. The first generic version for Linagliptin; Metformin Hydrochloride was by Sunshine Lake Pharma Co Ltd and was approved on Aug 30, 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; Metformin Hydrochloride generic, along with the locations of their manufacturing plants worldwide.


1. SUNSHINE

Sunshine Lake Pharma Co Ltd has filed for 3 different strengths of generic version for Linagliptin; Metformin Hydrochloride. All of these versions come by the name LINAGLIPTIN AND METFORMIN HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Sunshine.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2.5MG; 500MG

tablet Prescription ORAL AB Aug 30, 2021
2.5MG; 850MG

tablet Prescription ORAL AB Aug 30, 2021
2.5MG; 1GM

tablet Prescription ORAL AB Aug 30, 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
United States
Methuen Sunshine International Foods, Inc.
Portland Sunshine Dairy Foods Management LLC
Glenwood Springs Sunshine & Moons, LLC
Doral Sunshine Bottling Co, Inc.
Bridgeville Sunshine Burger & Specialty Food Company, LLC
Jacksonville Sunshine Peanut Company
Indianapolis SUNSHINE INTERNATIONAL LLC
Dublin Sunshine Mills, Inc
Alhambra Sunshine Bakery
Halifax Sunshine Mills, Inc.
Augusta Sunshine Honey Inc.
Columbus Sunshine Apiaries
Rochester Sunshine Fund Raising Co.
Artesia Sunshine Evergreen Inc.
North Las Vegas Sunshine Fresh Nevada LLC
Maumee Sunshine Inc Of Nw Ohio
Red Bay Sunshine Mills aka World Pet Care
Andrews Sunshine Dairy, LLC
Evergreen Sunshine Honey Bees LLC
Tupelo Sunshine Mills, Inc.
Peru
Tambogrande Sunshine Export S.A.C
India
Surat Sunshine Global Hospital
Thailand
Tha Mai Sunshine International
China
Dongguan Sunshine Lake Pharma Co., Ltd
Mozambique
Boane Sunshine Nut Limitada





2. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Linagliptin; Metformin Hydrochloride. All of these versions come by the name LINAGLIPTIN AND METFORMIN HYDROCHLORIDE. 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
2.5MG; 500MG

tablet Discontinued ORAL N/A Mar 30, 2023
2.5MG; 850MG

tablet Discontinued ORAL N/A Mar 30, 2023
2.5MG; 1GM

tablet Discontinued ORAL N/A Mar 30, 2023