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SYNJARDY Drug Profile

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Which patents cover Synjardy, and what generic alternatives are available?

Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are five patents protecting this drug and two Paragraph IV challenges.

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

US ANDA Litigation and Generic Entry Outlook for Synjardy

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

There have been two 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

International Patents:	142
US Patents:	3
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

See drug prices for SYNJARDY

Recent Litigation for SYNJARDY

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited	2019-08-28
Boehringer Ingelheim Pharmaceuticals Inc. v. Cadila Healthcare Limited	2019-07-11
Boehringer Ingelheim Pharmaceuticals Inc. v. Annora Pharma Private Limited

See all SYNJARDY litigation

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

Paragraph IV (Patent) Challenges for SYNJARDY

Tradename	Dosage	Ingredient	NDA	Submissiondate
SYNJARDY	TABLET;ORAL	empagliflozin; metformin hydrochloride	206111	2018-08-01

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
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	208658-004	Dec 9, 2016		RX	Yes	Yes			Y	Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-002	Aug 26, 2015		RX	Yes	No				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	208658-003	Dec 9, 2016		RX	Yes	No				Y
Boehringer Ingelheim	SYNJARDY	empagliflozin; metformin hydrochloride	TABLET;ORAL	206111-004	Aug 26, 2015		RX	Yes	Yes				Y

International Patents for SYNJARDY

Country	Patent Number	Estimated Expiration
Hong Kong	1188777
South Korea	20060133021
World Intellectual Property Organization (WIPO)	2014161919
European Patent Office	2360164
Japan	5147469
China	103467423
Eurasian Patent Organization	013079

Supplementary Protection Certificates for SYNJARDY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1730131	568	Finland
1730131	14C0074	France		PRODUCT NAME: EMPAGLIFLOZINE ET SES SELS, EN PARTICULIER L'EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930 20140527
1730131	CR 2014 00054	Denmark		PRODUCT NAME: EMPAGLIFLOZIN OG SALTE DERAF, SAERLIGT EMPAGLIFLOZIN; REG. NO/DATE: EU1/14/930/001/018 20140527
1730131	92555	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
1730131	122014000099	Germany		PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
2187879	2017/018	Ireland		PRODUCT NAME: COMBINATION OF: EMPAGLIFLOZIN; AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1146 20161111
1730131	C300696	Netherlands		PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522