QTERNMET XR Drug Patent Profile

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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 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 nineteen 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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 210874 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

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Glossary

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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
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			⤷ 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-003	May 2, 2019	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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.

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Country	Patent Number	Title	Estimated Expiration
Croatia	P20141007		⤷ Sign Up
Portugal	1261586		⤷ Sign Up
Spain	2553573		⤷ Sign Up
Peru	20040760	C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2	⤷ Sign Up
Spain	2582646		⤷ Sign Up
Denmark	2508188		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for QTERNMET XR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	13C0022	France	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
2139494	C20200028 00358	Estonia	⤷ Sign Up	PRODUCT NAME: SAKSAGLIPTIIN JA DAPAGLIFLOSIIN;REG NO/DATE: EU/1/16/1108; 19.07.2016
1506211	C01506211/02	Switzerland	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
1261586	SZ 4/2010	Austria	⤷ Sign Up	PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID
1506211	132014902277722	Italy	⤷ Sign Up	PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
1506211	136 5005-2013	Slovakia	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

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Summary for QTERNMET XR

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QTERNMET XR

Patents protecting QTERNMET XR

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

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for QTERNMET XR