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Last Updated: September 25, 2020

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QTERNMET XR Drug Profile

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Which patents cover Qternmet Xr, and what generic alternatives are available?

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

This drug has three hundred and eighty-nine 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. One supplier is listed for this compound. Additional details are available on the dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride profile page.

US ANDA Litigation and 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 twelve 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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Drug patent expirations by year for QTERNMET XR
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

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 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-001 May 2, 2019 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-002 May 2, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for QTERNMET XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 2013/013 Ireland   Start Trial PRODUCT NAME: DAPAGLIFLOZIN AND PHARACEUTICALLY ACCEPTABLE SALTS THREOF; REGISTRATION NO/DATE: EU/1/12/795/001-010 20121112
1506211 C01506211/01 Switzerland   Start Trial PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
1261586 2012C/016 Belgium   Start Trial 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
1506211 588 Finland   Start Trial
1506211 SPC/GB13/021 United Kingdom   Start Trial PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114
1506211 CA 2014 00037 Denmark   Start Trial 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
1261586 SZ 4/2010 Austria   Start Trial PRODUCT NAME: SAXAGLIPTIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND SAXAGLIPTINHYDROCHLORID
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
Moodys
Baxter
Johnson and Johnson
Express Scripts

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.