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Last Updated: December 2, 2020

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DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride and what is the scope of freedom to operate?

Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride has three hundred and ninety-four patent family members in forty-seven countries.

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

Recent Clinical Trials for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

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

SponsorPhase
Sabyasachi SenPhase 4
First People's Hospital, Shunde ChinaPhase 4
the Fifth Affiliated Hospital of Zunyi Medical UniversityPhase 4

See all DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE clinical trials

Pharmacology for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

US Patents and Regulatory Information for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN 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 QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 DISCN Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-001 May 2, 2019 DISCN 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 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-002 May 2, 2019 DISCN 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 DISCN 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 DISCN 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 DISCN 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

Expired US Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

International Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Country Patent Number Estimated Expiration
Hungary 230380   Start Trial
World Intellectual Property Organization (WIPO) 0168603   Start Trial
South Korea 20140124874   Start Trial
India 3573DE2004   Start Trial
European Patent Office 2139494   Start Trial
Taiwan I258468   Start Trial
Canada 2987757   Start Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 SPC/GB14/050 United Kingdom   Start Trial PRODUCT NAME: A COMBINATION OF DAPAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND METFORMIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/900 20140121
1261586 SPC/GB10/001 United Kingdom   Start Trial PRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001
2498758 LUC00152 Luxembourg   Start Trial PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1506211 92182 Luxembourg   Start Trial PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1261586 CA 2012 00014 Denmark   Start Trial
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
1506211 PA2014026 Lithuania   Start Trial PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; 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:

Boehringer Ingelheim
Dow
AstraZeneca
Johnson and Johnson
Mallinckrodt
Medtronic

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