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Last Updated: June 21, 2024

DAPAGLIFLOZIN - Generic Drug Details


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

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

Dapagliflozin has four hundred and thirty-nine patent family members in fifty-one countries.

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

Summary for DAPAGLIFLOZIN
Drug Prices for DAPAGLIFLOZIN

See drug prices for DAPAGLIFLOZIN

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAPAGLIFLOZIN
Generic Entry Date for DAPAGLIFLOZIN*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DAPAGLIFLOZIN

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

SponsorPhase
EMSPhase 3
Odense University HospitalPhase 4
Göteborg UniversityPhase 4

See all DAPAGLIFLOZIN clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up2.5MG;1GMTABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up10MG;1GMTABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up10MG;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 Strength NDA ANDAs Submitted Submissiondate
FARXIGA Tablets dapagliflozin 5 mg and 10 mg 202293 20 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 FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-001 Feb 27, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Astrazeneca Ab QTERN dapagliflozin; saxagliptin hydrochloride TABLET;ORAL 209091-002 May 2, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for DAPAGLIFLOZIN

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AstraZeneca AB Forxiga dapagliflozin EMEA/H/C/002322
Type 2 diabetes mellitusForxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureForxiga is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseForxiga is indicated in adults for the treatment of chronic kidney disease.
Authorised no no no 2012-11-11
AstraZeneca AB Edistride dapagliflozin EMEA/H/C/004161
Type 2 diabetes mellitusEdistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance.in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureEdistride is indicated in adults for the treatment of symptomatic chronic heart failure.Chronic kidney diseaseEdistride is indicated in adults for the treatment of chronic kidney disease.
Authorised no no no 2015-11-09
Viatris Limited Dapagliflozin Viatris dapagliflozin EMEA/H/C/006006
Type 2 diabetes mellitusDapagliflozin Viatris is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise- as monotherapy when metformin is considered inappropriate due to intolerance.- in addition to other medicinal products for the treatment of type 2 diabetes.For study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1.Heart failureDapagliflozin Viatris is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.Chronic kidney diseaseDapagliflozin Viatris is indicated in adults for the treatment of chronic kidney disease.
Authorised yes no no 2023-03-24
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for DAPAGLIFLOZIN

Country Patent Number Title Estimated Expiration
Argentina 065809 FORMULACIONES FARMACEUTICAS QUE CONTIENEN UN INHIBIDOR SGLT2 ⤷  Sign Up
South Korea 20220044234 다파글리플로진으로 박출률이 감소된 심부전을 치료하는 방법 (METHODS OF TREATING HEART FAILURE WITH REDUCED EJECTION FRACTION WITH DAPAGLIFLOZIN) ⤷  Sign Up
South Korea 101454051 ⤷  Sign Up
Finland 3524261 ⤷  Sign Up
China 104382880 Poly (lactide-co-glycolide)-based sustained release microcapsules comprising a polypeptide and a sugar ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DAPAGLIFLOZIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 C20140021 00131 Estonia ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOSIIN/METFORMIIN;REG NO/DATE: K(2014)308 (LOPLIK) 21.01.2014
1506211 13C0022 France ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
1734971 2012C/017 Belgium ⤷  Sign Up PRODUCT NAME: EXENATIDE; AUTHORISATION NUMBER AND DATE: EU/1/11/696/001 20110617
1506211 122014000070 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211 C01506211/02 Switzerland ⤷  Sign Up PRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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