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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 four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and ten patent family members in thirty-five countries.

The generic ingredient in SYNJARDY 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.

Summary for SYNJARDY

International Patents:	110
US Patents:	2
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SYNJARDY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYNJARDY
DailyMed Link:	SYNJARDY at DailyMed

Pharmacology for SYNJARDY

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

Synonyms for SYNJARDY

Empagliflozin / metformin

Empagliflozin and metformin HCl

Empagliflozin and metformin hydrochloride

Empagliflozin mixture with metformin hydrochloride

Metformin / Empagliflozin

S900006750

Synjardy XR

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	208658-003	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				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	208658-001	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			Y
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	206111-002	Aug 26, 2015		RX	Yes	No				Y

Paragraph IV (Patent) Challenges for SYNJARDY

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	5 mg/1000 mg10 mg/1000 mg12.5 mg/1000 mg25 mg/1000 mg
	Tablets	5 mg/500 mg5 mg/1000 mg12.5 mg/500 mg12.5 mg/1000 mg

International Patents for SYNJARDY

Country	Patent Number	Estimated Expiration
Germany	102004012676
Hong Kong	1188775
Germany	602005009745
Austria	407938
South Africa	200705883
Croatia	P20120627
Croatia	P20100033

Supplementary Protection Certificates for SYNJARDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	CA 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140522
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 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	1490061-7	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526
1730131	PA2014035,C1730131	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	122014000099	Germany		PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
1730131	PA2014035	Lithuania		PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522