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Last Updated: August 8, 2020

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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 eleven 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 sixty-three 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:263
US Patents:11
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 26
Suppliers / Packagers: 1
Clinical Trials: 81
DailyMed Link:dapagliflozin; metformin hydrochloride at DailyMed
Recent Clinical Trials for dapagliflozin; metformin hydrochloride

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SponsorPhase
The University of The West IndiesPhase 2/Phase 3
Dong-A ST Co., Ltd.Phase 3
Chang Gung Memorial HospitalPhase 2

See all dapagliflozin; metformin hydrochloride clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MG;500MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial5MG;1GMTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial5MG;500MGTABLET, 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 205649-002 Oct 29, 2014 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 XIGDUO XR dapagliflozin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 205649-002 Oct 29, 2014 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 dapagliflozin; metformin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 18/2013 Austria   Start Trial PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211 PA2014026 Lithuania   Start Trial PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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