Jentadueto Patent Expiration

Jentadueto 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. Jentadueto'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 Dec 04, 2030. Details of Jentadueto'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

(4 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).
US8846695

(Pediatric)

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

(5 years from now)

Active
US9155705

(Pediatric)

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Nov, 2030

(5 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
US9155705 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
May, 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
US10973827

(Pediatric)

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

(4 years from now)

Active
US9415016

(Pediatric)

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

(4 years from now)

Active
US10022379

(Pediatric)

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

(4 years from now)

Active
US10973827 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Apr, 2029

(4 years from now)

Active
US10022379 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Apr, 2029

(4 years from now)

Active
US9415016 DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Apr, 2029

(4 years from now)

Active
US8673927

(Pediatric)

Uses of DPP-IV inhibitors
Nov, 2027

(2 years from now)

Active
US9173859 Uses of DPP IV inhibitors
May, 2027

(2 years from now)

Active
US8673927 Uses of DPP-IV inhibitors
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, 5 months from now)

Active
US8883805 Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Nov, 2025

(11 months from now)

Active
US7407955

(Pediatric)

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Nov, 2025

(10 months from now)

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

(1 year, 4 months ago)

Expired
US8119648 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Aug, 2023

(1 year, 4 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 Jentadueto's patents.

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

Activity Date Patent Number
Patent litigations
Expire Patent 17 Jun, 2024 US8178541
Expire Patent 25 Mar, 2024 US8119648
Patent eGrant Notification 27 Feb, 2024 US11911388
Patent Issue Date Used in PTA Calculation 27 Feb, 2024 US11911388
Recordation of Patent eGrant 27 Feb, 2024 US11911388
Mail Patent eGrant Notification 27 Feb, 2024 US11911388
Email Notification 27 Feb, 2024 US11911388
Recordation of Patent Grant Mailed 27 Feb, 2024 US11911388
Email Notification 08 Feb, 2024 US11911388
Payment of Maintenance Fee, 8th Year, Large Entity 08 Feb, 2024 US9415016 (Litigated)


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 Jentadueto and ongoing litigations to help you estimate the early arrival of Jentadueto generic.

Jentadueto's Litigations

Jentadueto 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 Jentadueto's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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 Jentadueto. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jentadueto, 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 Jentadueto.

Exclusivity Information

Jentadueto holds 7 exclusivities out of which 5 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Jentadueto's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Combination(NC) Jan 30, 2015
New Chemical Entity Exclusivity(NCE) May 02, 2016
M(M-146) Jul 30, 2017
M(M-258) Jul 03, 2022
M(M-252) Mar 30, 2023
M(M-295) Jun 20, 2026
Pediatric Exclusivity(PED) Dec 20, 2026

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Several oppositions have been filed on Jentadueto'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 Jentadueto's generic, the next section provides detailed information on ongoing and past EP oppositions related to Jentadueto patents.

Jentadueto's Oppositions Filed in EPO

Jentadueto 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
Patent litigations
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
EP09728065A Jun, 2019 isarpatent - Patent- und Rechtsanwälte Behnisch Barth Charles Hassa Peckmann und Partner mbB Revoked
EP09728065A Jun, 2019 HGF Limited Revoked
EP09728065A Jun, 2019 Galenicum Health S.L.U. Revoked
EP09728065A Jun, 2019 Hexal AG Revoked
EP07728723A Jan, 2015 Hexal AG Revoked


US patents provide insights into the exclusivity only within the United States, but Jentadueto 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 Jentadueto's family patents as well as insights into ongoing legal events on those patents.

Jentadueto's Family Patents

Jentadueto has patent protection in a total of 47 countries. It's US patent count contributes only to 11.4% of its total global patent coverage. 4 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Jentadueto.

Family Patents

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Generic Launch

Generic Release Date:

Jentadueto's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 04, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Jentadueto Generic API suppliers:

Linagliptin; Metformin Hydrochloride is the generic name for the brand Jentadueto. 2 different companies have already filed for the generic of Jentadueto, with Sunshine having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Jentadueto's generic

How can I launch a generic of Jentadueto before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Jentadueto's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Jentadueto'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 Jentadueto -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg 04 May, 2015 8 30 Aug, 2021 04 Jun, 2030 Deferred

Alternative Brands for Jentadueto

Jentadueto which is used for treating type 2 diabetes mellitus., has several other brand drugs in the same treatment category and using the same active ingredient (Linagliptin; Metformin Hydrochloride). 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
Boehringer Ingelheim
Tradjenta Used for treating type 2 diabetes, especially in patients with renal impairment and insufficient glycemic control.
Jentadueto Xr

(uses Linagliptin; Metformin Hydrochloride)

used for managing type 2 diabetes with renal impairment and inadequate glycemic control.
Merck Sharp Dohme
Januvia Used for managing glycemic control in adults with type 2 diabetes mellitus, often in combination with other medications like metformin or insulin.
Msd Sub Merck
Janumet used for managing type 2 diabetes mellitus.

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; Metformin Hydrochloride. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Boehringer Ingelheim
Trijardy Xr


Apart from brand drugs containing the same ingredient, some generics have also been filed for Linagliptin; Metformin Hydrochloride, Jentadueto's active ingredient. Check the complete list of approved generic manufacturers for Jentadueto





About Jentadueto

Jentadueto is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for treating type 2 diabetes mellitus. Jentadueto uses Linagliptin; Metformin Hydrochloride as an active ingredient. Jentadueto was launched by Boehringer Ingelheim in 2012.

Approval Date:

Jentadueto was approved by FDA for market use on 30 January, 2012.

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 Jentadueto is 30 January, 2012, its NCE-1 date is estimated to be 20 December, 2025.

Active Ingredient:

Jentadueto uses Linagliptin; Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Linagliptin; Metformin Hydrochloride ingredient

Treatment:

Jentadueto is used for treating type 2 diabetes mellitus.

Dosage:

Jentadueto is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
2.5MG;850MG TABLET Prescription ORAL
2.5MG;500MG TABLET Prescription ORAL
2.5MG;1GM TABLET Prescription ORAL