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Last Updated: September 25, 2022

QTERN Drug Patent 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 sixty-two 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 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

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Drug patent expirations by year for QTERN
Drug Prices for QTERN

See drug prices for QTERN

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 Strength NDA ANDAs Submitted Submissiondate
QTERN Tablets dapagliflozin; saxagliptin hydrochloride 5 mg/5 mg 209091 1 2020-07-29
QTERN Tablets dapagliflozin; saxagliptin hydrochloride 10 mg/5 mg 209091 5 2018-01-08

US Patents and Regulatory Information for QTERN

QTERN is protected by twelve US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QTERN 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 QTERN

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

Pharmaceutical formulations containing an SGLT2 inhibitor
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
Patented Use: TREATMENT OF TYPE 2 DIABETES MELLITUS

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN

Pharmaceutical formulations containing an SGLT2 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN

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

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN

Crystal structures of SGLT2 inhibitors and processes for preparing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN

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

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 QTERN

NEW STRENGTH
Exclusivity Expiration: See Plans and Pricing

EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
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 210874-003 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 210874-002 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 210874-003 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 QTERN

International Patents for QTERN

When does loss-of-exclusivity occur for QTERN?

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

Argentina

Patent: 1730
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07265246
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0713544
Estimated Expiration: See Plans and Pricing

Patent: 2017015106
Estimated Expiration: See Plans and Pricing

Patent: 2017021516
Estimated Expiration: See Plans and Pricing

Canada

Patent: 53344
Estimated Expiration: See Plans and Pricing

Patent: 24318
Estimated Expiration: See Plans and Pricing

Patent: 85797
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07001915
Estimated Expiration: See Plans and Pricing

China

Patent: 1479287
Estimated Expiration: See Plans and Pricing

Patent: 3145773
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60299
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0141007
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15738
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 69374
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8229
Estimated Expiration: See Plans and Pricing

Patent: 0428
Estimated Expiration: See Plans and Pricing

Patent: 8259
Estimated Expiration: See Plans and Pricing

Patent: 5999
Estimated Expiration: See Plans and Pricing

Patent: 0900066
Estimated Expiration: See Plans and Pricing

Patent: 1171333
Estimated Expiration: See Plans and Pricing

Patent: 1490902
Estimated Expiration: See Plans and Pricing

Patent: 1791254
Estimated Expiration: See Plans and Pricing

Patent: 2091391
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 69374
Estimated Expiration: See Plans and Pricing

Patent: 57918
Estimated Expiration: See Plans and Pricing

Patent: 45466
Estimated Expiration: See Plans and Pricing

Patent: 63807
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 27359
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5882
Estimated Expiration: See Plans and Pricing

Patent: 4180
Estimated Expiration: See Plans and Pricing

Patent: 4181
Estimated Expiration: See Plans and Pricing

Patent: 4182
Estimated Expiration: See Plans and Pricing

Patent: 5688
Estimated Expiration: See Plans and Pricing

Japan

Patent: 13889
Estimated Expiration: See Plans and Pricing

Patent: 66651
Estimated Expiration: See Plans and Pricing

Patent: 37187
Estimated Expiration: See Plans and Pricing

Patent: 09545525
Estimated Expiration: See Plans and Pricing

Patent: 13209394
Estimated Expiration: See Plans and Pricing

Patent: 15071636
Estimated Expiration: See Plans and Pricing

Patent: 16172758
Estimated Expiration: See Plans and Pricing

Patent: 17222681
Estimated Expiration: See Plans and Pricing

Patent: 19059779
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8566
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9143
Estimated Expiration: See Plans and Pricing

Patent: 7155
Estimated Expiration: See Plans and Pricing

Patent: 08015377
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4346
Estimated Expiration: See Plans and Pricing

Patent: 9190
Estimated Expiration: See Plans and Pricing

Patent: 9195
Estimated Expiration: See Plans and Pricing

Patent: 9202
Estimated Expiration: See Plans and Pricing

Norway

Patent: 085169
Estimated Expiration: See Plans and Pricing

Peru

Patent: 080349
Estimated Expiration: See Plans and Pricing

Patent: 120776
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 012500168
Estimated Expiration: See Plans and Pricing

Poland

Patent: 69374
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 69374
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 638
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 2741
Estimated Expiration: See Plans and Pricing

Patent: 201402181S
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 69374
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0810475
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1493102
Estimated Expiration: See Plans and Pricing

Patent: 090023643
Estimated Expiration: See Plans and Pricing

Spain

Patent: 21665
Estimated Expiration: See Plans and Pricing

Patent: 59862
Estimated Expiration: See Plans and Pricing

Patent: 69130
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 21245
Estimated Expiration: See Plans and Pricing

Patent: 66876
Estimated Expiration: See Plans and Pricing

Patent: 19528
Estimated Expiration: See Plans and Pricing

Patent: 0811127
Estimated Expiration: See Plans and Pricing

Patent: 1406743
Estimated Expiration: See Plans and Pricing

Patent: 1509927
Estimated Expiration: See Plans and Pricing

Patent: 1546054
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 765
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 QTERN around the world.

Country Patent Number Title Estimated Expiration
Argentina 065809 FORMULACIONES FARMACEUTICAS QUE CONTIENEN UN INHIBIDOR SGLT2 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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for QTERN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2139494 132020000000115 Italy See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN E DAPAGLIFLOZIN(QTERN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1108, 20160719
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
2139494 CA 2020 00035 Denmark See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN OG DAPAGLIFLOZIN; REG. NO/DATE: EU/1/16/1108 20160719
>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

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.