Glyxambi is a drug owned by Boehringer Ingelheim. It is protected by 29 US drug patents filed from 2015 to 2023. Out of these, 23 drug patents are active and 6 have expired. Glyxambi's patents have been open to challenges since 01 August, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 03, 2034. Details of Glyxambi'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. | |||
| US7579449 | Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture |
Aug, 2028
(3 years from now) | Active |
| US7713938 | Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments |
Apr, 2027
(2 years from now) | Active |
| 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). | |||
|
US10258637 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Oct, 2034
(9 years from now) | Active |
|
US11090323 (Pediatric) | Pharmaceutical composition, methods for treating and uses thereof |
Oct, 2034
(9 years from now) | Active |
| US9949998 | Pharmaceutical composition, methods for treating and uses thereof |
Jun, 2034
(9 years from now) | Active |
| US10258637 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US11833166 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US11090323 | Pharmaceutical composition, methods for treating and uses thereof |
Apr, 2034
(9 years from now) | Active |
| US10406172 | Pharmaceutical composition, methods for treating and uses thereof |
Jun, 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 |
|
US8551957 (Pediatric) | Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate |
Apr, 2030
(5 years from now) | Active |
| US8551957 | Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate |
Oct, 2029
(4 years from now) | Active |
|
US7579449 (Pediatric) | Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture |
Feb, 2029
(4 years from now) | Active |
|
US11033552 (Pediatric) | DPP IV inhibitor formulations |
Nov, 2027
(2 years from now) | Active |
|
US8673927 (Pediatric) | Uses of DPP-IV inhibitors |
Nov, 2027
(2 years from now) | Active |
|
US7713938 (Pediatric) | Crystalline form of 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments |
Oct, 2027
(2 years from now) | Active |
| US8673927 | Uses of DPP-IV inhibitors |
May, 2027
(2 years from now) | Active |
| US9173859 | Uses of DPP IV inhibitors |
May, 2027
(2 years from now) | Active |
| US11033552 | DPP IV inhibitor formulations |
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 |
| 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
|
| 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
|
| US7459428 | Method of regulating glucose metabolism, and reagents related thereto |
Feb, 2019
(5 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
|
| 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 Glyxambi's patents.
Latest Legal Activities on Glyxambi's Patents
Given below is the list of recent legal activities going on the following patents of Glyxambi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 17 Jun, 2024 | US8178541 |
| Expire Patent Critical | 25 Mar, 2024 | US8119648 |
| Maintenance Fee Reminder Mailed Critical | 01 Jan, 2024 | US8178541 |
| Recordation of Patent eGrant | 05 Dec, 2023 | US11833166 |
| Patent eGrant Notification | 05 Dec, 2023 | US11833166 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Dec, 2023 | US11833166 |
| Recordation of Patent Grant Mailed Critical | 05 Dec, 2023 | US11833166 |
| Email Notification Critical | 05 Dec, 2023 | US11833166 |
| Mail Patent eGrant Notification | 05 Dec, 2023 | US11833166 |
| Email Notification Critical | 16 Nov, 2023 | US11833166 |
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 Glyxambi and ongoing litigations to help you estimate the early arrival of Glyxambi generic.
Glyxambi's Litigations
Glyxambi 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 Glyxambi's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| 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 Glyxambi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Glyxambi, 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 Glyxambi.
Exclusivity Information
Glyxambi holds 5 exclusivities. All of its exclusivities have expired in 2023. Details of Glyxambi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Jan 30, 2018 |
| New Chemical Entity Exclusivity(NCE) | Aug 01, 2019 |
| New Indication(I-739) | Dec 02, 2019 |
| M(M-258) | Jul 03, 2022 |
| M(M-252) | Mar 30, 2023 |
Several oppositions have been filed on Glyxambi'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 Glyxambi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Glyxambi patents.
Glyxambi's Oppositions Filed in EPO
Glyxambi 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 |
| EP10703288A | Jan, 2021 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP10703288A | Jan, 2021 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP10703288A | Dec, 2020 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Gillard, Richard Edward | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Stada-Arzneimittel Aktiengesellschaft | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | EGIS Gyógyszergyár Zártkörüen Müködö Részvénytársaság | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Granted and Under Opposition |
| EP14715578A | Aug, 2019 | KRKA, d.d., Novo mesto | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | Hexal AG | Granted and Under Opposition |
| EP08787264A | Jul, 2017 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP10175188A | Dec, 2015 | Galenicum Health S.L. | Revoked |
| EP10175188A | Dec, 2015 | Generics (UK) Limited | Revoked |
| EP10175188A | Dec, 2015 | STADA Arzneimittel AG | Revoked |
| EP10175188A | Dec, 2015 | Hexal AG | Revoked |
| EP10175188A | Dec, 2015 | Teva Pharmaceutical Industries LTD. | Revoked |
| EP10175638A | Jul, 2015 | STADA Arzneimittel AG | Revoked |
| EP10175638A | Jul, 2015 | Generics [UK] Limited (trading as Mylan) | Revoked |
| EP10175638A | Jul, 2015 | Hexal AG | Revoked |
| EP10175638A | Jul, 2015 | Teva Pharmaceutical Industries Ltd. | Revoked |
| EP07728723A | Jan, 2015 | Hexal AG | Revoked |
US patents provide insights into the exclusivity only within the United States, but Glyxambi 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 Glyxambi's family patents as well as insights into ongoing legal events on those patents.
Glyxambi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Glyxambi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 03, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Glyxambi Generics:
There are no approved generic versions for Glyxambi as of now.
How can I launch a generic of Glyxambi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Glyxambi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Glyxambi'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 Glyxambi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 10 mg/5 mg and 25 mg/5 mg | 01 Aug, 2018 | 9 | 11 Jun, 2034 |
Alternative Brands for Glyxambi
Glyxambi which is used for managing type 2 diabetes mellitus, including in patients with renal impairment, through the administration of drugs such as linagliptin and empagliflozin., has several other brand drugs in the same treatment category and using the same active ingredient (Empagliflozin; Linagliptin). 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 |
| |||||||||
About Glyxambi
Glyxambi is a drug owned by Boehringer Ingelheim. It is used for managing type 2 diabetes mellitus, including in patients with renal impairment, through the administration of drugs such as linagliptin and empagliflozin. Glyxambi uses Empagliflozin; Linagliptin as an active ingredient. Glyxambi was launched by Boehringer Ingelheim in 2015.
Approval Date:
Glyxambi was approved by FDA for market use on 30 January, 2015.
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 Glyxambi is 30 January, 2015, its NCE-1 date is estimated to be 01 August, 2018.
Active Ingredient:
Glyxambi uses Empagliflozin; Linagliptin as the active ingredient. Check out other Drugs and Companies using Empagliflozin; Linagliptin ingredient
Treatment:
Glyxambi is used for managing type 2 diabetes mellitus, including in patients with renal impairment, through the administration of drugs such as linagliptin and empagliflozin.
Dosage:
Glyxambi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG;5MG | TABLET | Prescription | ORAL |
| 25MG;5MG | TABLET | Prescription | ORAL |