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SYNJARDY XR Drug Profile

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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 four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-three patent family members in thirty-six countries.

The generic ingredient in SYNJARDY XR is empagliflozin; metformin hydrochloride. There are twenty-one 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 XR

International Patents:	143
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
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

Pharmacology for SYNJARDY XR

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

US Patents and Regulatory Information for 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	208658-001	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
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	Y
Boehringer Ingelheim	SYNJARDY XR	empagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208658-001	Dec 9, 2016		RX	Yes	No

Paragraph IV (Patent) Challenges for SYNJARDY XR

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	5 mg/1000 mg10 mg/1000 mg12.5 mg/1000 mg25 mg/1000 mg

International Patents for SYNJARDY XR

Country	Document Number	Estimated Expiration
Uruguay	29505
New Zealand	550464
Argentina	048041
World Intellectual Property Organization (WIPO)	2006064033
Hungary	S1400056

Supplementary Protection Certificates for SYNJARDY XR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
555	Luxembourg		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS,EN PARTICULIER EMPAGLIFLOZINE-L INGREDIENT ACTIF APPROUVE EST L EMPAGLIFLOZINE DE FORMULE(1S)-1,5-ANHYDRO-1-C-4-CHLORO-3-(4-(3S)OXOLAN-3-YLOXY PHENYL)METHYLPHENYL-D-GLUCITOL
2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
2014000099	Germany		PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
00696	Netherlands		PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
90061-7	Sweden		PRODUCT NAME: EMPAGLIFLOZIN AND SALTS THEREOF, IN PARTICULAR EMPAGLIFLOZIN; REG. NO/DATE: EU/1/14/930 20140522