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Last Updated: September 28, 2021

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Dapagliflozin; metformin hydrochloride - Generic Drug Details

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What are the generic drug sources for dapagliflozin; metformin hydrochloride and what is the scope of patent protection?

Dapagliflozin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Astrazeneca Ab and is included in two NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; metformin hydrochloride has two hundred and thirty-one patent family members in forty-six countries.

There are twenty-six drug master file entries for dapagliflozin; metformin hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for dapagliflozin; metformin hydrochloride
International Patents:231
US Patents:8
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 26
Finished Product Suppliers / Packagers: 1
Clinical Trials: 86
DailyMed Link:dapagliflozin; metformin hydrochloride at DailyMed
Recent Clinical Trials for dapagliflozin; metformin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novartis PharmaceuticalsPhase 2
Boryung Pharmaceutical Co., LtdPhase 3
Germán Ramón Bautista LópezN/A

See all dapagliflozin; metformin hydrochloride clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial10MG;1GMTABLET, EXTENDED RELEASE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial10MG;500MGTABLET, EXTENDED RELEASE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial5MG;1GMTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dapagliflozin; metformin hydrochloride
Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
XIGDUO XR TABLET, EXTENDED RELEASE;ORAL dapagliflozin; metformin hydrochloride 205649 2018-10-29
XIGDUO XR TABLET, EXTENDED RELEASE;ORAL dapagliflozin; metformin hydrochloride 205649 2018-01-08

US Patents and Regulatory Information for dapagliflozin; metformin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-003 Oct 29, 2014 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-001 May 2, 2019 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-004 May 2, 2019 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-001 May 2, 2019 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Astrazeneca Ab XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-001 Oct 29, 2014 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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 dapagliflozin; metformin hydrochloride

International Patents for dapagliflozin; metformin hydrochloride

Country Patent Number Estimated Expiration
Eurasian Patent Organization 201490902 ⤷  Free Forever Trial
Israel 245688 ⤷  Free Forever Trial
Norway 20044915 ⤷  Free Forever Trial
World Intellectual Property Organization (WIPO) 03099836 ⤷  Free Forever Trial
China 1407990 ⤷  Free Forever Trial
Russian Federation 2489151 ⤷  Free Forever Trial
China 102711739 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 2014C/041 Belgium ⤷  Free Forever Trial PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121
1506211 588 Finland ⤷  Free Forever Trial
1506211 C300677 Netherlands ⤷  Free Forever Trial PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
1506211 132014902277722 Italy ⤷  Free Forever Trial 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 92496 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
1506211 CA 2013 00019 Denmark ⤷  Free Forever Trial
1506211 13C0022 France ⤷  Free Forever Trial PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Mallinckrodt
Dow
McKinsey
Colorcon

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