Kombiglyze Xr is a drug owned by Astrazeneca Ab. It is protected by 4 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 2 have expired. Kombiglyze Xr's patents have been open to challenges since 31 July, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 13, 2025. Details of Kombiglyze 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 focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8628799 | Coated tablet formulation and method |
Jul, 2025
(a month from now) | Active |
| US9339472 | Coated tablet formulation and method |
Jul, 2025
(a month from now) | Active |
| USRE44186 | Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method |
Jul, 2023
(1 year, 9 months ago) |
Expired
|
| US6395767 | Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method |
Feb, 2021
(4 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 Kombiglyze Xr's patents.
Latest Legal Activities on Kombiglyze Xr's Patents
Given below is the list of recent legal activities going on the following patents of Kombiglyze Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Nov, 2023 | US9339472 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Jun, 2021 | US8628799 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 31 Oct, 2019 | US9339472 |
| Recordation of Patent Grant Mailed Critical | 17 May, 2016 | US9339472 |
| Patent Issue Date Used in PTA Calculation Critical | 17 May, 2016 | US9339472 |
| Email Notification Critical | 28 Apr, 2016 | US9339472 |
| Issue Notification Mailed Critical | 27 Apr, 2016 | US9339472 |
| Application Is Considered Ready for Issue Critical | 19 Apr, 2016 | US9339472 |
| Dispatch to FDC | 19 Apr, 2016 | US9339472 |
| Issue Fee Payment Received Critical | 18 Apr, 2016 | US9339472 |
FDA has granted several exclusivities to Kombiglyze Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kombiglyze 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 Kombiglyze Xr.
Exclusivity Information
Kombiglyze Xr holds 4 exclusivities. All of its exclusivities have expired in 2020. Details of Kombiglyze Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 31, 2014 |
| M(M-134) | May 24, 2016 |
| M(M-175) | Apr 05, 2019 |
| M(M-198) | Feb 27, 2020 |
Several oppositions have been filed on Kombiglyze 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 Kombiglyze Xr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Kombiglyze Xr patents.
Kombiglyze Xr's Oppositions Filed in EPO
Kombiglyze Xr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 20, 2017, by Galenicum Health S.L.. This opposition was filed on patent number EP05756474A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP10179007A | Mar, 2017 | Galenicum Health S.L. | Patent maintained as amended |
| EP05756474A | Jan, 2017 | Galenicum Health S.L. | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Kombiglyze 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 Kombiglyze Xr's family patents as well as insights into ongoing legal events on those patents.
Kombiglyze Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kombiglyze Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 13, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kombiglyze Xr Generic API suppliers:
Metformin Hydrochloride; Saxagliptin Hydrochloride is the generic name for the brand Kombiglyze Xr. 3 different companies have already filed for the generic of Kombiglyze Xr, with Dr Reddys Labs Sa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kombiglyze Xr's generic
How can I launch a generic of Kombiglyze Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kombiglyze Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kombiglyze 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 Kombiglyze Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg | 31 Jul, 2013 | 3 | 31 Jul, 2023 | Extinguished |
Alternative Brands for Kombiglyze Xr
Kombiglyze Xr which is used for improving glycemic control in adults with type 2 diabetes mellitus., has several other brand drugs using the same active ingredient (Metformin Hydrochloride; Saxagliptin 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 | |
|---|---|---|
| Astrazeneca Ab |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Metformin Hydrochloride; Saxagliptin Hydrochloride, Kombiglyze Xr's active ingredient. Check the complete list of approved generic manufacturers for Kombiglyze Xr
About Kombiglyze Xr
Kombiglyze Xr is a drug owned by Astrazeneca Ab. It is used for improving glycemic control in adults with type 2 diabetes mellitus. Kombiglyze Xr uses Metformin Hydrochloride; Saxagliptin Hydrochloride as an active ingredient. Kombiglyze Xr was launched by Astrazeneca Ab in 2010.
Approval Date:
Kombiglyze Xr was approved by FDA for market use on 05 November, 2010.
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 Kombiglyze Xr is 05 November, 2010, its NCE-1 date is estimated to be 31 July, 2013.
Active Ingredient:
Kombiglyze Xr uses Metformin Hydrochloride; Saxagliptin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Metformin Hydrochloride; Saxagliptin Hydrochloride ingredient
Treatment:
Kombiglyze Xr is used for improving glycemic control in adults with type 2 diabetes mellitus.
Dosage:
Kombiglyze Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| 500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE | Discontinued | ORAL |