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Last Updated: October 20, 2021

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Dapagliflozin - Generic Drug Details

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What are the generic drug 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 nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin has three hundred and seventy-three patent family members in forty-eight countries.

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

Summary for dapagliflozin
International Patents:373
US Patents:19
Tradenames:4
Applicants:1
NDAs:4
Drug Master File Entries: 26
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 95
Clinical Trials: 298
Patent Applications: 3,636
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in dapagliflozin?dapagliflozin excipients list
DailyMed Link:dapagliflozin at DailyMed
Recent Clinical Trials for dapagliflozin

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

SponsorPhase
Washington University School of MedicinePhase 2
University Hospital, RouenPhase 2
Novartis PharmaceuticalsPhase 2

See all dapagliflozin clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial2.5MG;1GMTABLET, EXTENDED RELEASE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial10MG;1GMTABLET, EXTENDED RELEASE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial10MG;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
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 QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 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 210874-004 May 2, 2019 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 ⤷  Free Forever Trial ⤷  Free Forever 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 PA2014026 Lithuania ⤷  Free Forever Trial PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
2498758 CA 2020 00017 Denmark ⤷  Free Forever Trial PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113
1506211 42/2014 Austria ⤷  Free Forever Trial PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Merck
Express Scripts
McKesson
Moodys

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