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Last Updated: June 22, 2021

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QTERN Drug Profile


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Which patents cover Qtern, and what generic alternatives are available?

Qtern is a drug marketed by Astrazeneca Ab and is included in two NDAs. There are nine patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in QTERN 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 Qtern

Qtern was eligible for patent challenges on January 8, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 16, 2029. This may change due to patent challenges or generic licensing.

There have been thirteen 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 QTERN
Drug Prices for QTERN

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for QTERN
Generic Entry Date for QTERN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.

Paragraph IV (Patent) Challenges for QTERN
Tradename Dosage Ingredient NDA Submissiondate
QTERN TABLET;ORAL dapagliflozin; saxagliptin hydrochloride 209091 2020-07-29
QTERN TABLET;ORAL dapagliflozin; saxagliptin hydrochloride 209091 2018-01-08

US Patents and Regulatory Information for QTERN

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 210874-003 May 2, 2019 DISCN Yes No   Try Before You Buy   Try Before You Buy Y Y   Try Before You Buy
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-002 May 2, 2019 DISCN Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-004 May 2, 2019 DISCN Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 DISCN Yes No   Try Before You Buy   Try Before You Buy Y   Try Before You Buy
>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 QTERN

Supplementary Protection Certificates for QTERN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 C20140021 00131 Estonia   Try Before You Buy PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
1506211 13C0022 France   Try Before You Buy PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
1506211 C01506211/01 Switzerland   Try Before You Buy PRODUCT NAME: DAPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 65176 19.08.2014
1506211 122014000070 Germany   Try Before You Buy PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
McKinsey
Baxter
Boehringer Ingelheim
Dow

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