Dapagliflozin; metformin hydrochloride - Generic Drug Details

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What are the generic drug sources for dapagliflozin; metformin hydrochloride and what is the scope of patent protection?

Dapagliflozin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Astrazeneca Ab and is included in two NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; metformin hydrochloride has two hundred and thirty-six patent family members in forty-six countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for dapagliflozin; metformin hydrochloride

International Patents:	236
US Patents:	11
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	102
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dapagliflozin; metformin hydrochloride
DailyMed Link:	dapagliflozin; metformin hydrochloride at DailyMed

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

Generic Entry Date for dapagliflozin; metformin hydrochloride^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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

Sponsor	Phase
Eli Lilly and Company	Phase 3
Institute of Liver and Biliary Sciences, India	N/A
Ain Shams University	Phase 1/Phase 2

See all dapagliflozin; metformin hydrochloride clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	10MG;1GM	TABLET, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	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; metformin hydrochloride

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

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

A10BA	Biguanides
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

Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	2.5 mg/1000 mg	205649	1	2018-10-29
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg	205649	10	2018-01-08

US Patents and Regulatory Information for dapagliflozin; metformin hydrochloride

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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-002	May 2, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Astrazeneca Ab	QTERNMET XR	dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	210874-004	May 2, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ 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; metformin hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-004	Oct 29, 2014	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for dapagliflozin; metformin hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Norway	347770		⤷ Sign Up
Slovenia	1506211		⤷ Sign Up
Chile	2007001915	Compuesto cristalino de 6-[4-cloro-3-(4-etoxibencil)fenil]tetrahidropiran-2,3,4,5,-tetraol; procedimiento de preparacion; composicion farmaceutica que comprende a dicho compuesto; y su uso para preparar un medicamento para tratar diabetes, dislipidemia, obesidad, entre otras.	⤷ Sign Up
European Patent Office	3363807	COMPOSITION PHARMACEUTIQUE COMPRENANT SOLVATE DE (S)-PROPYLENE GLYCOL DE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ÉTHOXY-BENZYL)-PHÉNYL]-6-HYDROXYMÉTHYL-2-MÉTHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL CRISTALLINE (PHARMACEUTICAL COMPOSITION COMPRISING CRYSTALLINE (2S,3R,4S,5S,6R)-2-[4-CHLORO-3-(4-ETHOXY-BENZYL)-PHENYL]-6-HYDROXYMETHYL-2-METHOXY-TETRAHYDRO-PYRAN-3,4,5-TRIOL (S)-PROPYLENE GLYCOL SOLVATE)	⤷ Sign Up
Taiwan	200811127	Crystal structures of SGLT2 inhibitors and processes for preparing same	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for dapagliflozin; metformin hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	13C0022	France	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZINE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/795/001 20121112
2139494	122020000043	Germany	⤷ Sign Up	PRODUCT NAME: SAXAGLIPTIN UND DAPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/16/1108 20160715
2498758	2020C/509	Belgium	⤷ Sign Up	PRODUCT NAME: QTRILMET - 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
1506211	136 5005-2013	Slovakia	⤷ Sign Up	PRODUCT NAME: DAPAGLIFLOZIN; FIRST REGISTRATION NO/DATE: EU/1/12/795/001, EU/1/12/795/002, EU/1/12/795/003, EU/1/12/795/004, EU/1/12/795/005, EU/1/12/795/006, EU/1/12/795/007, EU/1/12/795/007, EU/1/12/795/008, EU/1/12/795/009, EU/1/12/795/010 20121112
2498758	C20200010 00328	Estonia	⤷ Sign Up	PRODUCT NAME: METFORMIIN/SAKSAGLIPTIIN/DAPAGLIFLOSIIN;REG NO/DATE: EU/1/19/1401 13.11.2019
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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