Jentadueto Xr is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is protected by 27 US drug patents filed from 2016 to 2024. Out of these, 18 drug patents are active and 9 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 06, 2033. Details of Jentadueto Xr's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US7407955 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
May, 2025
(9 months from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6635280 | Extending the duration of drug release within the stomach during the fed mode |
Sep, 2016
(7 years ago) |
Expired
|
| US6340475 | Extending the duration of drug release within the stomach during the fed mode |
Sep, 2016
(7 years ago) |
Expired
|
| US6303661 | Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals |
Apr, 2017
(7 years 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
|
| US6488962 | Tablet shapes to enhance gastric retention of swellable controlled-release oral dosage forms |
Jun, 2020
(4 years ago) |
Expired
|
| US8178541 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Aug, 2023
(11 months ago) |
Expired
|
| US8119648 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Aug, 2023
(11 months ago) |
Expired
|
|
US7407955 (Pediatric) | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions |
Nov, 2025
(1 year, 3 months from now) | Active |
| US8883805 | Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines |
Nov, 2025
(1 year, 3 months from now) | Active |
|
US8883805 (Pediatric) | Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines |
May, 2026
(1 year, 9 months 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 |
|
US8673927 (Pediatric) | Uses of DPP-IV inhibitors |
Nov, 2027
(3 years from now) | Active |
|
US9173859 (Pediatric) | Uses of DPP IV inhibitors |
Nov, 2027
(3 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 |
|
US10022379 (Pediatric) | DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation |
Oct, 2029
(5 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
(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 |
| 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 |
| 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 (Pediatric) | DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation |
Nov, 2030
(6 years from now) | Active |
| US9555001 | Pharmaceutical composition and uses thereof |
Mar, 2033
(8 years from now) | Active |
|
US9555001 (Pediatric) | Pharmaceutical composition and uses thereof |
Sep, 2033
(9 years from now) | Active |
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 Xr's patents.
Latest Legal Activities on Jentadueto Xr's Patents
Given below is the list of recent legal activities going on the following patents of Jentadueto Xr.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 Xr and ongoing litigations to help you estimate the early arrival of Jentadueto Xr generic.
Jentadueto Xr's Litigations
Jentadueto Xr has 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 or infringement of this patent, with Boehringer Ingelheim Pharmaceuticals Inc. as the respondent. Click below to track the latest information on how companies are challenging Jentadueto Xr's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8673927 | August, 2016 | Terminated-Adverse Judgment | Boehringer Ingelheim Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. |
| US8846695 | August, 2016 | Terminated-Adverse Judgment | Boehringer Ingelheim Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. |
| US9173859 | August, 2016 | Terminated-Denied | Boehringer Ingelheim Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. |
FDA has granted some exclusivities to Jentadueto Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jentadueto Xr, 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 Xr.
Exclusivity Information
Jentadueto Xr holds 4 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Jentadueto Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| 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 Jentadueto Xr'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 Xr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Jentadueto Xr patents.
Jentadueto Xr's oppositions filed in EPO
Jentadueto Xr 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 |
| 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 Xr 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 Xr's family patents as well as insights into ongoing legal events on those patents.
Jentadueto Xr's family patents
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Generic Launch
Generic Release Date:
Jentadueto Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 06, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jentadueto Xr Generics:
Linagliptin; Metformin Hydrochloride is the generic name for the brand Jentadueto Xr. 2 different companies have already filed for the generic of Jentadueto Xr, with Sunshine having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Jentadueto Xr's generic
How can I launch a generic of Jentadueto Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Jentadueto Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Jentadueto Xr'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 Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2.5 mg/1000 mg 5 mg/1000 mg | 28 Mar, 2018 | 1 | 21 May, 2030 |
About Jentadueto Xr
Jentadueto Xr is a drug owned by Boehringer Ingelheim Pharmaceuticals Inc. It is used for managing type 2 diabetes with renal impairment and inadequate glycemic control. Jentadueto Xr uses Linagliptin; Metformin Hydrochloride as an active ingredient. Jentadueto Xr was launched by Boehringer Ingelheim in 2016.
Market Authorisation Date:
Jentadueto Xr was approved by FDA for market use on 27 May, 2016.
Active Ingredient:
Jentadueto Xr uses Linagliptin; Metformin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Linagliptin; Metformin Hydrochloride ingredient
Treatment:
Jentadueto Xr is used for managing type 2 diabetes with renal impairment and inadequate glycemic control.
Dosage:
Jentadueto Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 2.5MG;1GM | TABLET, EXTENDED RELEASE | Prescription | ORAL |