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Last Updated: February 3, 2023

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 five branded drugs marketed by Zydus Pharms and Astrazeneca Ab, and is included in five NDAs. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for dapagliflozin
International Patents:388
US Patents:19
Tradenames:5
Applicants:2
NDAs:5
Drug Master File Entries: 26
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 102
Clinical Trials: 374
Patent Applications: 4,747
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
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 4
Universitas Sebelas MaretPhase 3
Children's Discovery InstitutePhase 1

See all dapagliflozin clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing2.5MG;1GMTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing10MG;1GMTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing10MG;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 202293-001 Jan 8, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-002 May 2, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab QTERNMET XR dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 210874-003 May 2, 2019 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 See Plans and Pricing See Plans and Pricing
>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
Forxiga 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.Heart failureForxiga is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.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 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 failureEdistride is indicated in adults for the treatment of symptomatic chronic heart failure with reduced ejection fraction.Chronic kidney diseaseEdistride is indicated in adults for the treatment of chronic kidney disease. 
Authorised no no no 2015-11-09
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for dapagliflozin

Country Patent Number Title Estimated Expiration
Israel 195882 צורות גבישיות של נגזרות של (1 s)-1, 5-אנהידרו-1- c -(3-((פניל)מתיל)פניל)-d-גלוציטול עם חומצות אמיניות ושימוש בהן לטיפול בסכרת (Crystalline forms of (1s)-1,5-anhydro-1-c-(3-(phenyl)methyl)phenyl)-d-glucitol derivatives with amino acids and use thereof for the treatment of diabetes) See Plans and Pricing
South Korea 102359799 See Plans and Pricing
European Patent Office 3524261 PROCÉDÉS DE TRAITEMENT DU DIABÈTE ET DE RÉDUCTION DU POIDS CORPOREL (EXENDIN FOR TREATING DIABETES AND REDUCING BODY WEIGHT) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dapagliflozin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 CA 2014 00037 Denmark See Plans and Pricing 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
2498758 LUC00152 Luxembourg See Plans and Pricing 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
1734971 16/2012 Austria See Plans and Pricing PRODUCT NAME: EXENATID; REGISTRATION NO/DATE: EU/1/11/696/001-002 (MITTEILUNG) 20110623
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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