EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details

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

Empagliflozin; metformin hydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Zydus Pharms, and is included in three NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Empagliflozin; metformin hydrochloride has two hundred and forty-nine patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

International Patents:	249
US Patents:	10
Tradenames:	3
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	62
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
DailyMed Link:	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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

Sponsor	Phase
Tanta University	Phase 3
Handok Inc.	Phase 3
Karolinska Institutet	N/A

See all EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE clinical trials

Pharmacology for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYNJARDY	Tablets	empagliflozin; metformin hydrochloride	5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg	206111	4	2018-08-01
SYNJARDY XR	Extended-release Tablets	empagliflozin; metformin hydrochloride	5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg	208658	3	2018-08-01

US Patents and Regulatory Information for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-001	Aug 26, 2015		RX	Yes	No
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-002	Aug 26, 2015		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes					Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-002	Aug 26, 2015		RX	Yes	No
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-001	Aug 26, 2015		RX	Yes	No					Y

Expired US Patents for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016

International Patents for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	027181	ТВЕРДАЯ ФАРМАЦЕВТИЧЕСКАЯ ДОЗИРОВАННАЯ ФОРМА, ВКЛЮЧАЮЩАЯ ИНГИБИТОР SGLT-2 И ГИДРОХЛОРИД МЕТФОРМИНА, ДЛЯ ЛЕЧЕНИЯ (SOLID PHARMACEUTICAL DOSAGE FORM COMPRISING SGLT-2 INHIBITOR AND METFORMIN HYDROCHLORIDE FOR TREATING)
Argentina	078517	COMPOSICION FARMACEUTICA, FORMA DE DOSIFICACION FARMACEUTICA, PROCEDIMIENTO PARA SU PREPARACION, METODOS PARA SU TRATAMIENTO Y SUS USOS
Canada	2826640	COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE LA METFORMINE ET UN INHIBITEUR DE DPP-4 OU UN INHIBITEUR DE SGLT-2 (PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP-4 INHIBITOR OR A SGLT-2 INHIBITOR)
World Intellectual Property Organization (WIPO)	2014161919
Eurasian Patent Organization	013079	КРИСТАЛЛИЧЕСКАЯ ФОРМА 1-ХЛОР-4-(β-D-ГЛЮКОПИРАНОЗ-1-ИЛ)-2-[4-((S)-ТЕТРАГИДРОФУРАН-3-ИЛОКСИ)БЕНЗИЛ]БЕНЗОЛА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ЕЕ ПРИМЕНЕНИЕ ДЛЯ ПРИГОТОВЛЕНИЯ ЛЕКАРСТВЕННЫХ СРЕДСТВ (CRYSTALLINE FORM OF 1-CHLORO-4(&bgr;-D-GLUCOPYRANOS-1-YL)-2-[4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL]-BENZENE, A METHOD FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS)
Ukraine	89040	ЗАМЕЩЕННЫЕ ГЛЮКОПИРАНОЗИЛОМ БЕНЗОЛЬНЫЕ ПРОИЗВОДНЫЕ, ЛЕКАРСТВЕННОЕ СРЕДСТВО, КОТОРОЕ СОДЕРЖИТ ЭТИ СОЕДИНЕНИЯ;ЗАМІЩЕНІ ГЛЮКОПІРАНОЗИЛОМ БЕНЗОЛЬНІ ПОХІДНІ, ЛІКАРСЬКИЙ ЗАСІБ, ЯКИЙ МІСТИТЬ ЦІ СПОЛУКИ (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS)
New Zealand	613301	Pharmaceutical compositions comprising metformin and a dpp-4 inhibitor or a sglt-2 inhibitor

Supplementary Protection Certificates for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	PA2014035	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1730131	122014000099	Germany		PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	C300696	Netherlands		PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
1730131	CR 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527
1730131	2014/055	Ireland		PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN ((1S)-1,5- ANHYDRO-1-C-(4-CHLORO-3-((4-(((3S)-OXOLAN-3-YL)OXY))PHENYL)METHYL)PHENYL)- D-GLUCITOL); REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	C01730131/04	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021