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Last Updated: October 4, 2024

QTERNMET XR Drug Patent Profile


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Which patents cover Qternmet Xr, 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 six patents protecting this drug.

This drug has three hundred and forty-six patent family members in forty-eight 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 eighteen 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

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Summary for QTERNMET XR
International Patents:346
US Patents:6
Applicants:1
NDAs:1
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for QTERNMET XR
DailyMed Link:QTERNMET XR at DailyMed
Drug patent expirations by year for QTERNMET XR
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QTERNMET XR is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Coated tablet formulation and method
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Bilayer tablet formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 210874-001 May 2, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-004 May 2, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-002 May 2, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-001 May 2, 2019 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Patent: Bilayer tablet formulations
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012011726
Patent: comprimidos de duas camadas, seu uso, e suas combinações farmacêuticas
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 80939
Patent: FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 87757
Patent: FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2711739
Patent: Bilayer tablet formulations
Estimated Expiration: ⤷  Sign Up

Patent: 5193761
Patent: BILAYER TABLET FORMULATIONS
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0181347
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 98758
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 98758
Patent: FORMULATIONS DE COMPRIMÉ BICOUCHE (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 15124
Patent: FORMULATIONS DE COMPRIMÉS BICOUCHES (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 40486
Estimated Expiration: ⤷  Sign Up

Patent: 000009
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 75522
Estimated Expiration: ⤷  Sign Up

Patent: 67299
Estimated Expiration: ⤷  Sign Up

Patent: 22862
Estimated Expiration: ⤷  Sign Up

Patent: 13510873
Estimated Expiration: ⤷  Sign Up

Patent: 15110630
Patent: 二層錠製剤 (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 17081943
Patent: 二層錠製剤 (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 18172418
Patent: 二層錠製剤 (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 498758
Estimated Expiration: ⤷  Sign Up

Patent: 2020003
Estimated Expiration: ⤷  Sign Up

Patent: 98758
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 5777
Patent: FORMULACIONES DE TABLETAS BICAPA. (BILAYER TABLET FORMULATIONS.)
Estimated Expiration: ⤷  Sign Up

Patent: 12005416
Patent: FORMULACIONES DE TABLETAS BICAPA. (BILAYER TABLET FORMULATIONS.)
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 20009
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 98758
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 98758
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 83920
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ (BI-LAYER TABLET COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 12757
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ (DOUBLE-LAYER TABLET COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 12123947
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ
Estimated Expiration: ⤷  Sign Up

Patent: 16112599
Patent: КОМПОЗИЦИЯ ДВУХСЛОЙНОЙ ТАБЛЕТКИ
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 756
Patent: FORMULACIJE TABLETA SA DVA SLOJA (BILAYER TABLET FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 98758
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 89107
Estimated Expiration: ⤷  Sign Up

Patent: 56888
Estimated Expiration: ⤷  Sign Up

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
Austria 295848 ⤷  Sign Up
Taiwan 201546054 Crystal structures of SGLT2 inhibitors and processes for preparing same ⤷  Sign Up
Mexico PA06013711 FORMULACION DE TABLETA REVESTIDA Y METODO. (COATED TABLET FORMULATION AND METHOD.) ⤷  Sign Up
Uruguay 26613 INHIBIDORES A BASE DE PIRROLIDINA FUSIONADA CON CICLOPROPILO DE DIPEPTIDIL PEPTIDASA IV Y MÉTODO ⤷  Sign Up
New Zealand 574346 CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for QTERNMET XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 122013000033 Germany ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1261586 2012C/016 Belgium ⤷  Sign Up PRODUCT NAME: UNE COMBINAISON DE PRODUITS DE SAXAGLIPTINE ET DE METFORMINE AINSI QUE TOUT SELS PHARMACEUTIQUEMENT ACCEPTABLES, DONT LES SELS DE CHLORHYDRATE DE SAXAGLIPTINE ET DE METFORMINE; AUTHORISATION NUMBER AND DATE: EU/1/11/731/001 20111128
2498758 PA2020003,C2498758 Lithuania ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER SAXAGLIPTIN HCL
1506211 CR 2014 00037 Denmark ⤷  Sign Up PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.