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SYNJARDY XR Drug Patent Profile

Which patents cover Synjardy Xr, and when can generic versions of Synjardy Xr launch?

Synjardy Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eight patent family members in forty-one countries.

The generic ingredient in SYNJARDY XR is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Synjardy Xr

Synjardy Xr was eligible for patent challenges on August 1, 2018.

There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SYNJARDY XR

International Patents:	208
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	5
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SYNJARDY XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYNJARDY XR
DailyMed Link:	SYNJARDY XR at DailyMed

See drug prices for SYNJARDY XR

Recent Clinical Trials for SYNJARDY XR

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

Sponsor	Phase
Genuine Research Center, Egypt	Phase 1
Hikma Pharma	Phase 1

See all SYNJARDY XR clinical trials

Pharmacology for SYNJARDY XR

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

Anatomical Therapeutic Chemical (ATC) Classes for SYNJARDY XR

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 SYNJARDY XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 SYNJARDY XR

SYNJARDY XR is protected by ten US patents and two FDA Regulatory Exclusivities.

Patents protecting SYNJARDY XR

FDA Regulatory Exclusivity protecting SYNJARDY XR

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					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No					Y
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	208658-003	Dec 9, 2016		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No					Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-003	Dec 9, 2016		RX	Yes	No					Y

Expired US Patents for SYNJARDY XR

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 SYNJARDY XR

See the table below for patents covering SYNJARDY XR around the world.

Country	Patent Number	Title	Estimated Expiration
Uruguay	37817	DERIVADOS DE BENCENO SUSTITUIDOS POR GLUCOPIRANOSILO, MEDICAMENTOS QUE CONTIENEN ESOS COMPUESTOS, SU APLICACIÓN Y PROCEDIMIENTO PARA SU PREPARACIÓN
Austria	E557013
Japan	2008524162
Israel	177043	GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF
Eurasian Patent Organization	033397	СПОСОБ ЛЕЧЕНИЯ ПРЕДДИАБЕТА, САХАРНОГО ДИАБЕТА 1 ТИПА ИЛИ 2 ТИПА ИЛИ УЛУЧШЕНИЯ ГЛИКЕМИЧЕСКОГО КОНТРОЛЯ У ПАЦИЕНТА С УКАЗАННЫМИ НАРУШЕНИЯМИ (METHOD OF TREATING PREDIABETES, TYPE 1 OR TYPE 2 DIABETES MELLITUS OR IMPROVING GLYCEMIC CONTROL IN A PATIENT WITH SAID DISORDERS)
Germany	102004040168	Glucopyranosyl-substituierte Phenyle, diese Verbindungen enthaltende Arzneimittel, deren Verwendung und Verfahren zu ihrer Herstellung (New glucopyranosyl-substituted benzene derivatives are sodium-dependent glucose cotransporter inhibitors, useful for treating e.g. metabolic disorders (type 1 and type 2 diabetes mellitus or metabolic acidosis))

Supplementary Protection Certificates for SYNJARDY XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	122014000099	Germany		PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	C01730131/05	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131	C01730131/03	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
1730131	PA2014035,C1730131	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	C 2014 039	Romania		PRODUCT NAME: EMPAGLIFOZIN SI SARURILE ACESTUIA, IN SPECIAL EMPAGLIFOZIN(1S)-1,5-ANHIDRO-1-C-{4-CLORO-3-[(4-{[(3S)-OXOLAN-3-IL]OXI}FENIL)METIL}-D-GLUCITOL; NATIONAL AUTHORISATION NUMBER: EU/1/14/930; DATE OF NATIONAL AUTHORISATION: 20140522; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/930; DATE OF FIRST AUTHORISATION IN EEA: 20140522