Dapagliflozin - Generic Drug Details

What are the generic 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

International Patents:	439
US Patents:	20
Tradenames:	4
Applicants:	1
NDAs:	4
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	427
Patent Applications:	3,227
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for dapagliflozin
What excipients (inactive ingredients) are in dapagliflozin?	dapagliflozin excipients list
DailyMed Link:	dapagliflozin at DailyMed

See drug prices for dapagliflozin

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dapagliflozin

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

Sponsor	Phase
Yale University	Phase 1
Yale University	Phase 2
American Heart Association	Phase 2

See all dapagliflozin clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN

Applicant	Application No.	Strength	Dosage Form
		2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;500MG	TABLET, 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

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014		RX	Yes	No			Y
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-001	Jan 8, 2014		RX	Yes	No
Astrazeneca Ab	FARXIGA	dapagliflozin	TABLET;ORAL	202293-002	Jan 8, 2014		RX	Yes	Yes
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019		DISCN	Yes	No				Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014		RX	Yes	No			Y

Expired US Patents for dapagliflozin

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

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

International Patents for dapagliflozin

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2435033	MÉTHODES POUR LE TRAITEMENT DE DIABÈTE DE TYPE 2 CHEZ DES PATIENTS RÉSISTANT À UN TRAITEMENT PRÉCÉDENT AVEC D'AUTRES MÉDICAMENTS ANTI-DIABÉTIQUES EMPLOYANT UN INHIBITEUR SGLT2 ET COMPOSITIONS ASSOCIÉES (METHODS FOR TREATING TYPE 2 DIABETES IN PATIENTS RESISTANT TO PREVIOUS TREATMENT WITH OTHER ANTI-DIABETIC DRUGS EMPLOYING AN SGLT2 INHIBITOR AND COMPOSITIONS THEREOF)
Singapore	11202100417R	METHODS OF TREATING HFPEF EMPLOYING DAPAGLIFLOZIN AND COMPOSITIONS COMPRISING THE SAME
World Intellectual Property Organization (WIPO)	2009143641
Australia	2008228714	Pharmaceutical formulations containing dapagliflozin propylene glycol hydrate
Australia	2020202887	Methods of treating heart failure with reduced ejection fraction with dapagliflozin

Supplementary Protection Certificates for dapagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2139494	PA2020522	Lithuania		PRODUCT NAME: SASAGLIPTINAS IR DAPAGLIFLOZINAS; REGISTRATION NO/DATE: EU/1/16/1108 20160715
1506211	PA2013008	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1734971	300526	Netherlands		PRODUCT NAME: EXENATIDE; REGISTRATION NO/DATE: EU/1/11/696/001-002 20110617
1506211	CR 2014 00037	Denmark		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	122020000018	Germany		PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111