EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details

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

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 University Hospital	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 XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-004	Dec 9, 2016		RX	Yes	Yes
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		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

International Patents for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	4226070
European Patent Office	2360165	Derives du benzol substitues par un glucopyranosyle, medicaments renfermant ces composes, leur utilisation et leur procede de production (Glucopyranosyl-substituted benzene derivatives, medicaments containing such compounds, their use and process for their manufacture)
Chile	2013002505	Composicion farmaceutica oral solida que comprende a) un nucleo de liberacion prolongada que contiene metformina, b) un recubrimiento sellador opcional, y c) un recubrimiento externo de liberacion inmediata que comprende a un agente activo, tal como un inhibidor de dpp-4 o de sglt-2; uso para tratar diabetes mellitus tipo 2.

Supplementary Protection Certificates for EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	C01730131/05	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022
1730131	568	Finland
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015