Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride - Generic Drug Details

What are the generic sources for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride and what is the scope of freedom to operate?

Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride has three hundred and forty-three patent family members in forty-eight countries.

Summary for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

International Patents:	343
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	19
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride
DailyMed Link:	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Dosage:

TABLET, EXTENDED RELEASE;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; metformin hydrochloride; saxagliptin hydrochloride

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

Sponsor	Phase
Sabyasachi Sen	Phase 4
The Fifth Affiliated Hospital of Zunyi Medical College	Phase 4
First People's Hospital, Shunde China	Phase 4

See all dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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

US Patents and Regulatory Information for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

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	210874-002	May 2, 2019		DISCN	Yes	No			Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No			Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No			Y	Y
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No			Y	Y

Expired US Patents for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-001	May 2, 2019

International Patents for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2013510873
Montenegro	02643	FORMULACIJA I METOD OBLOŽENE TABLETE (COATED T ABLET FORMULATION AND METHOD)
New Zealand	589202	CRYSTALLINE SOLVATES AND COMPLEXES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
Ukraine	96765	КРИСТАЛЛИЧЕСКИЕ СОЛЬВАТЫ И КОМПЛЕКСЫ ПРОИЗВОДНЫХ (IS)-1,5-АНГИДРО-L-C-(3-((ФЕНИЛ)МЕТИЛ)ФЕНИЛ)-D-ГЛЮЦИТОЛА С АМИНОКИСЛОТАМИ КАК ИНГИБИТОРЫ БЕЛКА SGLT2, ПРИГОДНЫЕ В ЛЕЧЕНИИ ДИАБЕТА;КРИСТАЛІЧНІ СОЛЬВАТИ І КОМПЛЕКСИ ПОХІДНИХ (IS)-1,5-АНГІДРО-L-C-(3-((ФЕНІЛ)МЕТИЛ)ФЕНІЛ)-D-ГЛЮЦИТОЛУ З АМІНОКИСЛОТАМИ ЯК ІНГІБІТОРИ БІЛКА SGLT2, ПРИДАТНІ У ЛІКУВАННІ ДІАБЕТУ (CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ((PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)

Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	18/2013	Austria		PRODUCT NAME: DAPAGLIFLOZIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	588	Finland
2139494	301054	Netherlands		PRODUCT NAME: SAXAGLIPTIN AND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160719
2139494	34/2020	Austria		PRODUCT NAME: DAPAGLIFLOZIN PROPYLENGYLKOL HYDRAT/SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/16/1108 (MITTEILUNG) 20160715