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Last Updated: August 13, 2020

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DAPAGLIFLOZIN - Generic Drug Details

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What are the generic sources for dapagliflozin and what is the scope of patent protection?

Dapagliflozin is the generic ingredient in four branded drugs marketed by Astrazeneca Ab and is included in four NDAs. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin has three hundred and fifty-one patent family members in forty-six countries.

There are twenty-six drug master file entries for dapagliflozin. Three suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for DAPAGLIFLOZIN
Recent Clinical Trials for DAPAGLIFLOZIN

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

SponsorPhase
ParexelPhase 2
George Clinical Pty LtdPhase 2
The University of Texas Health Science Center at San AntonioPhase 1/Phase 2

See all DAPAGLIFLOZIN clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MG;500MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial2.5MG;1GMTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial10MG;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
Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN
Tradename Dosage Ingredient NDA Submissiondate
FARXIGA TABLET;ORAL dapagliflozin 202293 2018-01-08

US Patents and Regulatory Information for DAPAGLIFLOZIN

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 210874-001 May 2, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes   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 Y 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014   Start Trial   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014   Start Trial   Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DAPAGLIFLOZIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 2014C/041 Belgium   Start Trial PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121
2498758 PA2020003 Lithuania   Start Trial PRODUCT NAME: METFORMINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111
1506211 122014000071 Germany   Start Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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