Qternmet Xr Patent Expiration

Qternmet Xr is a drug owned by Astrazeneca Ab. It is protected by 10 US drug patents filed in 2019. Out of these, 6 drug patents are active and 4 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 12, 2030. Details of Qternmet 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7919598 Crystal structures of SGLT2 inhibitors and processes for preparing same
Dec, 2029

(4 years from now)

Active
US6515117 C-aryl glucoside SGLT2 inhibitors and method
Oct, 2025

(9 months from now)

Active
USRE44186 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
Jul, 2023

(1 year, 4 months ago)

Expired
US6414126 C-aryl glucoside SGLT2 inhibitors and method
Oct, 2020

(4 years ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9616028 Bilayer tablet formulations
Nov, 2030

(5 years from now)

Active
US8716251 Pharmaceutical formulations containing an SGLT2 inhibitor
Mar, 2028

(3 years from now)

Active
US8501698 Crystal structures of SGLT2 inhibitors and processes for preparing same
Jun, 2027

(2 years from now)

Active
US8628799 Coated tablet formulation and method
Jul, 2025

(6 months from now)

Active
US6936590 C-aryl glucoside SGLT2 inhibitors and method
Oct, 2020

(4 years ago)

Expired
US9198925 Pharmaceutical formulations containing an SGLT2 inhibitor
Oct, 2020

(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 Qternmet Xr's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 24 Sep, 2020 US9616028
Recordation of Patent Grant Mailed 11 Apr, 2017 US9616028
Patent Issue Date Used in PTA Calculation 11 Apr, 2017 US9616028
Email Notification 23 Mar, 2017 US9616028
Issue Notification Mailed 22 Mar, 2017 US9616028
Dispatch to FDC 02 Mar, 2017 US9616028
Application Is Considered Ready for Issue 02 Mar, 2017 US9616028
Issue Fee Payment Verified 24 Feb, 2017 US9616028
Issue Fee Payment Received 24 Feb, 2017 US9616028
Electronic Review 28 Nov, 2016 US9616028


FDA has granted several exclusivities to Qternmet Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Qternmet 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 Qternmet Xr.

Exclusivity Information

Qternmet Xr holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Qternmet Xr's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) May 02, 2022

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

Qternmet Xr's Oppositions Filed in EPO

Qternmet Xr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 30, 2015, by Lek Pharmaceuticals D.D.. This opposition was filed on patent number EP07784499A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP08732695A Dec, 2020 Stada-Arzneimittel Aktiengesellschaft Granted and Under Opposition
EP08732695A Dec, 2020 Kraus & Weisert Patentanwälte PartGmbB Granted and Under Opposition
EP08732695A Dec, 2020 Gedeon Richter Plc. Granted and Under Opposition
EP08732695A Dec, 2020 Galenicum Health S.L.U. Granted and Under Opposition
EP08732695A Dec, 2020 Generics [UK] Limited Granted and Under Opposition
EP08732695A Dec, 2020 Zentiva, k.s. Granted and Under Opposition
EP17203302A Aug, 2020 Generics (U.K.) Limited Granted and Under Opposition
EP10782113A Apr, 2019 Hoefer & Partner Patentanwälte mbB Granted and Under Opposition
EP15181545A Sep, 2018 Generics (U.K.) Limited Granted and Under Opposition
EP10179007A Mar, 2017 Galenicum Health S.L. Patent maintained as amended
EP05756474A Jan, 2017 Galenicum Health S.L. Patent maintained as amended
EP07784499A Apr, 2015 LEK Pharmaceuticals d.d. Patent maintained as amended


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

Qternmet Xr's Family Patents

Qternmet Xr has patent protection in a total of 48 countries. It's US patent count contributes only to 10.6% of its total global patent coverage. 11 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 Qternmet Xr.

Family Patents

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Generic Launch

Generic Release Date:

Qternmet Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 12, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Qternmet Xr Generics:

There are no approved generic versions for Qternmet Xr as of now.

Alternative Brands for Qternmet Xr

Qternmet Xr which is used for managing blood sugar levels in individuals with type 2 diabetes mellitus., has several other brand drugs in the same treatment category . 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
Astrazeneca Ab
Qtern Used for the treatment of type 2 diabetes mellitus in patients who have inadequate control with dapagliflozin.
Farxiga used for treating heart failure and type 2 diabetes.
Xigduo Xr used for managing type 2 diabetes mellitus when glycemic control is not achievable with other medications.
Boehringer Ingelheim
Tradjenta Used for treating type 2 diabetes, especially in patients with renal impairment and insufficient glycemic control.
Cosette
Welchol Used for lowering serum glucose levels in adults with type 2 diabetes mellitus and lowering cholesterol levels.
Janssen Pharms
Invokana used for the treatment of type 2 diabetes mellitus and reduction of cardiovascular and kidney-related risks.
Invokamet Used for reducing the risk of kidney disease, cardiovascular events, and treating type 2 diabetes mellitus patients.
Invokamet Xr used for treating type 2 diabetes and reducing the risk of kidney disease, cardiovascular events, and heart failure.
Sb Pharmco
Avandamet Used for managing and treating type 2 diabetes mellitus.





About Qternmet Xr

Qternmet Xr is a drug owned by Astrazeneca Ab. It is used for managing blood sugar levels in individuals with type 2 diabetes mellitus. Qternmet Xr uses Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride as an active ingredient. Qternmet Xr was launched by Astrazeneca Ab in 2019.

Approval Date:

Qternmet Xr was approved by FDA for market use on 02 May, 2019.

Active Ingredient:

Qternmet Xr uses Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dapagliflozin; Metformin Hydrochloride; Saxagliptin Hydrochloride ingredient

Treatment:

Qternmet Xr is used for managing blood sugar levels in individuals with type 2 diabetes mellitus.

Dosage:

Qternmet 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;EQ 2.5MG BASE TABLET, EXTENDED RELEASE Discontinued ORAL
5MG;1GM;EQ 5MG BASE TABLET, EXTENDED RELEASE Discontinued ORAL
2.5MG;1GM;EQ 2.5MG BASE TABLET, EXTENDED RELEASE Discontinued ORAL
10MG;1GM;EQ 5MG BASE TABLET, EXTENDED RELEASE Discontinued ORAL