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SYNJARDY Drug Profile

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When do Synjardy patents expire, and when can generic versions of Synjardy launch?

Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are three patents protecting this drug.

This drug has one hundred and eight patent family members in thirty-four countries.

The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are fourteen 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.

Summary for SYNJARDY

International Patents:	108
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	SYNJARDY at DailyMed

Pharmacology for SYNJARDY

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

US Patents and Regulatory Information for SYNJARDY

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	Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No			Y	Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-002	Dec 9, 2016		RX	Yes	No

Non-Orange Book US Patents for SYNJARDY

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,687,469	Glucopyranosyl-substituted benzene derivatives, medicaments containing such compounds, their use and process for their manufacture

International Patents for SYNJARDY

Country	Document Number	Estimated Expiration
Japan	2007246544
Croatia	P20100033
South Africa	200605511
Taiwan	200716586

Supplementary Protection Certificates for SYNJARDY

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131/01	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
00696	Netherlands		PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522