Unlock all Features See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Moodys
Baxter
Johnson and Johnson
Boehringer Ingelheim
Mallinckrodt
Colorcon

Last Updated: September 25, 2022

QTERNMET XR Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


When do Qternmet Xr patents expire, and when can generic versions of Qternmet Xr launch?

Qternmet Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are seven patents protecting this drug.

This drug has three hundred and ninety-eight patent family members in forty-seven countries.

The generic ingredient in QTERNMET XR is dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride. There are twenty-six drug master file entries for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Qternmet Xr

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 12, 2030. This may change due to patent challenges or generic licensing.

There have been sixteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

< Available with Subscription >

  Try it Free

Summary for QTERNMET XR
Drug patent expirations by year for QTERNMET XR
DrugPatentWatch® Estimated Generic Entry Opportunity Date for QTERNMET XR
Generic Entry Date for QTERNMET XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for QTERNMET XR

QTERNMET XR is protected by seven US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QTERNMET XR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QTERNMET XR

C-aryl glucoside SGLT2 inhibitors and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Coated tablet formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Bilayer tablet formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

FDA Regulatory Exclusivity protecting QTERNMET XR

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-004 May 2, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-004 May 2, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-004 May 2, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-001 May 2, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for QTERNMET XR

International Patents for QTERNMET XR

When does loss-of-exclusivity occur for QTERNMET XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 10319343
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012011726
Estimated Expiration: See Plans and Pricing

Canada

Patent: 80939
Estimated Expiration: See Plans and Pricing

Patent: 87757
Estimated Expiration: See Plans and Pricing

China

Patent: 2711739
Estimated Expiration: See Plans and Pricing

Patent: 5193761
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0181347
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 98758
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 98758
Estimated Expiration: See Plans and Pricing

Patent: 15124
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 40486
Estimated Expiration: See Plans and Pricing

Patent: 000009
Estimated Expiration: See Plans and Pricing

Japan

Patent: 75522
Estimated Expiration: See Plans and Pricing

Patent: 67299
Estimated Expiration: See Plans and Pricing

Patent: 22862
Estimated Expiration: See Plans and Pricing

Patent: 13510873
Estimated Expiration: See Plans and Pricing

Patent: 15110630
Estimated Expiration: See Plans and Pricing

Patent: 17081943
Estimated Expiration: See Plans and Pricing

Patent: 18172418
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 498758
Estimated Expiration: See Plans and Pricing

Patent: 2020003
Estimated Expiration: See Plans and Pricing

Patent: 98758
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 5777
Estimated Expiration: See Plans and Pricing

Patent: 12005416
Estimated Expiration: See Plans and Pricing

Norway

Patent: 20009
Estimated Expiration: See Plans and Pricing

Poland

Patent: 98758
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 98758
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 83920
Estimated Expiration: See Plans and Pricing

Patent: 12757
Estimated Expiration: See Plans and Pricing

Patent: 12123947
Estimated Expiration: See Plans and Pricing

Patent: 16112599
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 756
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 98758
Estimated Expiration: See Plans and Pricing

Spain

Patent: 89107
Estimated Expiration: See Plans and Pricing

Patent: 56888
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QTERNMET XR around the world.

Country Patent Number Title Estimated Expiration
Japan 2017081943 二層錠製剤 (BILAYER TABLET FORMULATIONS) See Plans and Pricing
Ukraine 77306 С-АРИЛ ГЛЮКОЗИДНЫЕ ИНГИБИТОРЫ SGLT2 И СПОСОБ ИХ ПРИМЕНЕНИЯ;С-АРИЛ ГЛЮКОЗИДНІ SGLT2 ІНГІБІТОРИ ТА СПОСІБ ЇХ ЗАСТОСУВАННЯ (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD FOR THEIR USE) See Plans and Pricing
Japan 2005531588 See Plans and Pricing
Montenegro 00091 C-ARIL GLUKOZID SGLT2 INHIBITORI I POSTUPAK ZA NJIHOVU UPOTREBU (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD) See Plans and Pricing
Portugal 1506211 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for QTERNMET XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2139494 301054 Netherlands See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
2498758 PA2020003,C2498758 Lithuania See Plans and Pricing PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1261586 CA 2010 00007 Denmark See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER SAXAGLIPTIN HCL
1261586 91650 Luxembourg See Plans and Pricing 91650, EXPIRES: 20241001
2498758 PA2020003 Lithuania See Plans and Pricing PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Colorcon
Medtronic
McKinsey
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.